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Background: The delivery of combination contraceptive steroids from a skin patch or vaginal ring offers potential advantages over the traditional oral route. The skin patch and vaginal ring could require a lower dose due to increased bioavailability and improved user compliance., Objectives: To compare the contraceptive effectiveness, cycle control, compliance, and safety of the skin patch or the vaginal ring versus combination oral contraceptives (COCs)., Search Strategy: We searched MEDLINE, POPLINE, CENTRAL, EMBASE, and LILACS for trials of the contraceptive patch or the vaginal ring. We contacted manufacturers and researchers to identify other trials., Selection Criteria: All randomized controlled trials comparing the skin patch or vaginal ring with a COC., Data Collection and Analysis: Data were abstracted by two authors and entered into RevMan. For dichotomous variables, the Peto odds ratio (OR) with 95% confidence intervals (CI) was calculated. For continuous variables, the weighted mean difference was computed., Main Results: We found three trials of the skin patch and eight of the vaginal ring. Contraceptive effectiveness was similar for the patch or ring and the comparison COC. Patch users reported more compliant cycles than COC users; ORs were 2.05 (95% CI 1.83 to 2.29) and 2.76 (95% CI 2.35 to 3.24) in two trials. One crossover ring trial had more noncompliance for the ring users. Satisfaction with method was higher for ring users than COC users in two studies. More patch users discontinued early than COC users: OR 1.58 (95% CI 1.25 to 1.99) and 1.45 (95% CI 1.11 to 1.90) in two trials. Patch users also had more discontinuation due to adverse events (AEs). The ring trials generally showed similar discontinuation for ring and COC users. Compared to COC users, patch users were more likely to report breast discomfort, dysmenorrhea, nausea, and vomiting. Ring users reported less nausea, irritability, and depression than COC users in single trials. However, ring users had more vaginitis and leukorrhea. Bleeding problems were generally similar or less common for the ring versus COC., Authors' Conclusions: Effectiveness rates were similar for the methods compared. The patch group had better compliance than the COC group. Compared to COC users, patch users had more side effects. Ring users generally had fewer adverse events than COC users but more vaginal irritation and discharge. The patch could lead to more discontinuation while the vaginal ring showed little difference. High losses to follow up can affect the validity of the results.

Background: Male hormonal contraception has been an elusive goal. Administration of sex steroids to men can shut off sperm production through effects on the pituitary and hypothalamus. However, this approach also decreases production of testosterone, so 'add-back' therapy is needed., Objectives: To summarize all randomized controlled trials of male hormonal contraception., Search Strategy: We searched the computerized databases CENTRAL, MEDLINE, EMBASE, POPLINE, and LILACS (each from inception to March 2006) for randomized controlled trials of hormonal contraception in men. We wrote to authors of identified trials to seek unpublished or published trials that we might have missed., Selection Criteria: We included all randomized controlled trials in any language that compared a steroid hormone with another contraceptive. We excluded non-steroidal male contraceptives, such as gossypol. We included both placebo and active-regimen control groups. All trials identified included only healthy men with normal semen analyses., Data Collection and Analysis: Azoospermia (absence of spermatozoa on semen examination) was the primary outcome measure. Data were insufficient to examine pregnancy rates and side effects., Main Results: We found 30 trials that met our inclusion criteria. The proportion of men who achieved azoospermia varied widely in reports to date. A few important differences emerged from these trials: levonorgestrel implants combined with injectable testosterone enanthate (TE) were more effective than levonorgestrel 125 microg daily combined with testosterone patches; levonorgestrel 500 mug daily improved the effectiveness of TE 100 mg injected weekly; desogestrel 150 mug was less effective than desogestrel 300 mug (with testosterone pellets); testosterone undecanoate (TU) 500 mg was less likely to produce azoospermia than TU 1000 mg (with levonorgestrel implants); norethisterone enanthate 200 mg with TU 1000 mg led to more azoospermia when given every 8 weeks versus 12 weeks; four implants of 7-alpha-methyl-19-nortestosterone (MENT) were more effective than two MENT implants. Several trials showed promising efficacy in terms of percentages with azoospermia. Three examined desogestrel and testosterone preparations or etonogestrel (metabolite of desogestrel) and testosterone, and two examined levonorgestrel and testosterone., Authors' Conclusions: No male hormonal contraceptive is ready for clinical use. Most trials were small exploratory studies. As a result, their power to detect important differences was limited and their results imprecise. In addition, the definition of oligozoospermia has been imprecise or inconsistent. To avoid bias, future trials need more attention to the methodological requirements for randomized controlled trials. More trials with adequate power would also be helpful.

Background: Currently, the two most common surgical techniques for approaching the vas during vasectomy are the incisional method and the no-scalpel technique. Whereas the conventional incisional technique involves the use of a scalpel to make one or two incisions, the no-scalpel technique uses a sharp-pointed, forceps-like instrument to puncture the skin. The no-scalpel technique aims to reduce adverse events, especially bleeding, bruising, hematoma, infection and pain and to shorten the operating time., Objectives: The objective of this review was to compare the effectiveness, safety, and acceptability of the incisional versus no-scalpel approach to the vas., Search Strategy: We searched the computerized databases of CENTRAL, MEDLINE, EMBASE, POPLINE and LILACS in May 2006. In addition, we searched the reference lists of relevant articles and book chapters., Selection Criteria: Randomized controlled trials and controlled clinical trials were included in this review. No language restrictions were placed on the reporting of the trials., Data Collection and Analysis: We assessed all titles and abstracts located in the literature searches and two authors independently extracted data from the articles identified for inclusion. Outcome measures included safety, acceptability, operating time, contraceptive efficacy, and discontinuation., Main Results: Two randomized controlled trials evaluated the no-scalpel technique and differed in their findings. The larger trial demonstrated less perioperative bleeding (Odds ratio (OR) 0.49; 95% Confidence Interval (CI) 0.27 to 0.89) and pain during surgery (OR 0.75; 95% CI 0.61 to 0.93), scrotal pain (OR 0.63; 95% 0.50 to 0.80), and incisional infection (OR 0.21; 95% CI 0.06 to 0.78) during follow up than the standard incisional group. Both studies found less hematoma with the no-scalpel technique (OR 0.23; 95% CI 0.15 to 0.36). Operations using the no-scalpel approach were faster and had a quicker resumption of sexual activity. The smaller study did not find these differences; however, the study could have failed to detect differences due to a small sample size as well as a high loss to follow up. Neither trial found differences in vasectomy effectiveness between the two approaches to the vas., Authors' Conclusions: The no-scalpel approach to the vas resulted in less bleeding, hematoma, infection, and pain as well as a shorter operation time than the traditional incision technique. No difference in effectiveness was found between the two approaches.

Background: Vasectomy is an increasingly popular and effective family planning method. A variety of vasectomy techniques are used worldwide, including various vas occlusion techniques (excision and ligation, thermal or electrocautery, and mechanical and chemical occlusion methods), as well as vasectomy with vas irrigation or with fascial interposition. Vasectomy guidelines largely rely on information from observational studies. Ideally, the choice of vasectomy techniques should be based on the best available evidence from randomized controlled trials., Objectives: The objective of this review was to compare the effectiveness, safety, acceptability and costs of vasectomy techniques for male sterilization., Search Strategy: We searched the computerized databases of CENTRAL, MEDLINE, EMBASE, POPLINE and LILACS. In addition, we searched the reference lists of relevant articles and book chapters., Selection Criteria: We included randomized controlled trials comparing vasectomy techniques., Data Collection and Analysis: We assessed all titles and abstracts located in the literature searches. Two reviewers independently extracted data from articles identified for inclusion. Outcome measures include contraceptive efficacy, safety, discontinuation, and acceptability., Main Results: Six studies met the inclusion criteria. One trial compared vas occlusion with clips versus a conventional vasectomy technique. No difference was found in failure to reach azoospermia. Three trials examined vasectomy with vas irrigation. Two studies looked at irrigation with water versus no irrigation, while one examined irrigation with water versus the spermicide euflavine. None found a difference between the groups for time to azoospermia. However, one trial reported that the median number of ejaculations to azoospermia was lower in the euflavine group compared to the water irrigation group. One high-quality trial compared vasectomy with fascial interposition versus vasectomy without fascial interposition. The fascial interposition group was less likely to have vasectomy failure. Fascial interposition had more surgical difficulties, but the groups were similar in side effects. Lastly, one trial found that an intra-vas was less likely to produce azoospermia than was no-scalpel vasectomy. More men were satisfied with the intra-vas device, however., Authors' Conclusions: For vas occlusion with clips or vasectomy with vas irrigation, no conclusions can be made as those studies were of low quality and underpowered. Fascial interposition reduced vasectomy failure. An intra-vas device was less effective in reducing sperm count than was no-scalpel vasectomy. Randomized controlled trials examining other vasectomy techniques were not available. More and better quality research is needed to examine vasectomy techniques.

Background: Acne is a common skin disorder among women. Although no uniform approach to the management of acne exists, combination oral contraceptives (COCs), which contain an estrogen and a progestin, often are prescribed for women., Objectives: To determine the effectiveness of combined oral contraceptives (COCs) for the treatment of facial acne compared to placebo or other active therapies., Search Strategy: We searched the computerized databases of the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, POPLINE, Biological Abstracts and LILACS for randomized controlled trials of COCs and acne. We wrote to authors of identified trials to seek any unpublished or published trials that we might have missed., Selection Criteria: All randomized controlled trials reported in any language that compared the effectiveness of a COC containing an estrogen and a progestin to placebo or another active therapy for acne in women were eligible., Data Collection and Analysis: We extracted data on total and specific (i.e., open or closed comedones, papules, pustules and nodules) facial lesion counts; acne severity grades; global assessments by the clinician or the participant and discontinuation due to adverse events. Data were entered and analyzed in RevMan., Main Results: The search yielded 23 trials: 5 placebo-controlled trials made 3 different comparisons, 17 trials made 13 comparisons between 2 different COC regimens, and 1 additional trial compared a COC to an antibiotic. COCs reduced acne lesion counts, severity grades and self-assessed acne compared to placebo. Differences in the comparative effectiveness of COCs containing varying progestin types and dosages, though, were less clear. COCs that contained chlormadinone acetate or cyproterone acetate improved acne better than levonorgestrel, although this apparent advantage was based on limited data. A COC with cyproterone acetate might result in better acne outcomes than one with desogestrel; however, the three studies comparing these COCs produced conflicting results. Likewise, levonorgestrel showed a slight improvement over desogestrel in acne outcomes in one trial, but a second trial found no difference between the COCs., Authors' Conclusions: The three COCs evaluated in placebo-controlled trials are effective in reducing inflammatory and non-inflammatory facial acne lesions. Few differences were found between COC types in their effectiveness for treating acne. How COCs compare to alternative acne treatments is unknown since limited data were available regarding this question.

Background: Currently, the two most common surgical techniques for approaching the vas during vasectomy are the incisional method and the no-scalpel technique. Whereas the conventional incisional technique involves the use of a scalpel to make one or two incisions, the no-scalpel technique uses a sharp-pointed, forceps-like instrument to puncture the skin. The no-scalpel technique aims to reduce adverse events, especially bleeding, bruising, hematoma, infection and pain and to shorten the operating time., Objectives: The objective of this review was to compare the effectiveness, safety, and acceptability of the incisional versus no-scalpel vasectomy approach to the vas., Search Strategy: We searched the computerized databases of CENTRAL, MEDLINE, EMBASE, POPLINE and LILACS in May 2006. In addition, we searched the reference lists of relevant articles and book chapters., Selection Criteria: Randomized controlled trials and controlled clinical trials were included in this review. No language restrictions were placed on the reporting of the trials., Data Collection and Analysis: We assessed all titles and abstracts located in the literature searches and two authors independently extracted data from the articles identified for inclusion. Outcome measures included safety, acceptability, operating time, contraceptive efficacy, and discontinuation., Main Results: Two randomized controlled trials evaluated the no-scalpel technique and differed in their findings. The larger trial demonstrated less perioperative bleeding (Odds ratio (OR) 0.49; 95% Confidence Interval (CI) 0.27 to 0.89) and pain during surgery (OR 0.75; 95% CI 0.61 to 0.93), scrotal pain (OR 0.63; 95% 0.50 to 0.80), and incisional infection (OR 0.21; 95% CI 0.06 to 0.78) during follow up than the standard incisional group. Both studies found less hematoma with the no-scalpel technique (OR 0.23; 95% CI 0.15 to 0.36). Operations using the no-scalpel approach were faster and had a quicker resumption of sexual activity. The smaller study did not find these differences; however, the study could have failed to detect differences due to a small sample size as well as a high loss to follow up. Neither trial found differences in vasectomy effectiveness between the two approaches to the vas., Authors' Conclusions: The no-scalpel approach to the vas resulted in less bleeding, hematoma, infection, and pain as well as a shorter operation time than the traditional incision technique. Although no difference in effectiveness was found between the two approaches, the sample sizes might have been too small to detect actual differences. Additional well-conducted randomized trials would help answer this question.

Background: The male condom, which consists of a thin sheath placed over the glans and shaft of the penis, is designed to prevent pregnancy by providing a physical barrier against the deposition of semen into the vagina during intercourse. Beginning in the 1990s, nonlatex male condoms made of polyurethane film or synthetic elastomers were developed as alternative male barrier methods for individuals with allergies, sensitivities or preferences that prevented the consistent use of condoms made of latex., Objectives: The review sought to evaluate nonlatex male condoms in comparison with latex condoms in terms of contraceptive efficacy, breakage and slippage, safety, and user preferences., Search Strategy: We searched computerized databases for randomized controlled trials of nonlatex condoms. We also wrote to the manufacturers of nonlatex condoms and known investigators in an attempt to locate any other trials not identified in our search., Selection Criteria: The review included all randomized controlled trials identified in the literature search that evaluated a male nonlatex condom made of polyurethane film or synthetic elastomers in comparison with a latex condom., Data Collection and Analysis: We evaluated all titles and abstracts located in the literature searches for inclusion. Two authors independently extracted data from the identified studies. We analyzed data with RevMan. The Peto odds ratio (Peto OR) with 95% confidence interval (CI) was calculated for each outcome of contraceptive efficacy, condom breakage and slippage, discontinuation of use, safety, and user preference. Contraceptive efficacy, early discontinuation, and safety outcomes were also measured with survival analysis techniques., Main Results: While the eZ.on condom did not protect against pregnancy as well as its latex comparison condom, no differences were found in the typical-use efficacy between the Avanti and the Standard Tactylon and their latex counterparts. The nonlatex condoms had significantly higher rates of clinical breakage than their latex comparison condoms: the Peto OR for clinical breakage ranged from 2.6 (95% CI 1.6 to 4.3) to 5.0 (95% CI 3.6 to 6.8). Few adverse events were reported. Substantial proportions of participants preferred the nonlatex condom or reported that they would recommend its use to others., Authors' Conclusions: Although the nonlatex condoms were associated with higher rates of clinical breakage than their latex comparison condoms, the new condoms still provide an acceptable alternative for those with allergies, sensitivities, or preferences that might prevent the consistent use of latex condoms. The contraceptive efficacy of the nonlatex condoms requires more research.

Background: Worldwide, hormonal contraceptives are among the most popular reversible contraceptives in current use. Despite their high theoretical effectiveness, typical use results in much lower effectiveness. In large part, this disparity reflects difficulties in adherence to the contraceptive regimen and low rates for long-term continuation., Objectives: To determine the effectiveness of ancillary techniques to improve adherence to, and continuation rates of, hormonal methods of contraception., Search Strategy: We searched computerized databases for randomized controlled trials (RCTs) comparing client-provider interventions with standard family planning counseling. Sources included CENTRAL, MEDLINE, EMBASE, POPLINE, LILACS, and PsycINFO., Selection Criteria: Randomized controlled trials (RCTs) of an intensive counseling technique or client-provider intervention versus routine family planning counseling. Interventions included group motivation; structured, peer, or multi-component counseling; and intensive reminders of appointments. Outcome measures were discontinuation, reasons for discontinuation, number of missed pills and on-time injections, and pregnancy., Data Collection and Analysis: The primary author evaluated all titles and abstracts from the searches to determine eligibility. Two authors independently extracted data from the included studies. With RevMan 4.2, we calculated the odds ratio for all dichotomous outcomes and the weighted mean difference for continuous data. The studies were so different that we could not conduct a meta-analysis., Main Results: We found six RCTs; only one showed a statistically significant benefit of the experimental intervention. In that trial, women who received repeated, structured information about the injectable contraceptive depo-medroxyprogesterone acetate (DMPA) were less likely to have discontinued the method by 12 months (OR 0.27; 95% CI 0.16 to 0.44) than were women who had routine counseling. The intervention group was also less likely to discontinue due to menstrual disturbances. In another study, the intervention group was less likely to discontinue due to dissatisfaction with the contraceptive method, but overall continuation was not affected., Authors' Conclusions: Most studies to date have shown no benefit of strategies to improve adherence and continuation. These trials have important limitations, however. Two had small sample sizes, several had high losses to follow-up, and the intervention and its intensity varied across the studies. High-quality research is a priority, since adherence and continuation are fundamentally important to the successful use of hormonal contraceptives.

Background: Weight gain is often considered a side effect of combination hormonal contraceptives, and many women and clinicians believe that an association exists. Concern about weight gain can limit the use of this highly effective method of contraception by deterring the initiation of its use and causing early discontinuation among users. However, a causal relationship between combination contraceptives and weight gain has not been established., Objectives: The aim of the review was to evaluate the potential association between combination contraceptive use and changes in weight., Search Strategy: We searched the computerized databases MEDLINE, POPLINE, CENTRAL, EMBASE, and LILACS for studies of combination contraceptives. We also wrote to known investigators and manufacturers to request information about other published or unpublished trials not discovered in our search., Selection Criteria: All English-language, randomized controlled trials were eligible if they had at least three treatment cycles and compared a combination contraceptive to a placebo or to a combination contraceptive that differed in drug, dosage, regimen, and/or study length., Data Collection and Analysis: All titles and abstracts located in the literature searches were assessed. Data were entered and analyzed with RevMan, and a second author verified the data entered. Depending on the data available, the weighted mean difference using a fixed effects model with 95% confidence intervals (CI) was calculated for the mean change in weight between baseline and post-treatment measurements or the Peto odds ratio with 95% confidence intervals was calculated using the proportion of women who gained or lost more than a specified amount of weight., Main Results: The three placebo-controlled, randomized trials did not find evidence supporting a causal association between combination oral contraceptives or a combination skin patch and weight gain. Most comparisons of different combination contraceptives showed no substantial difference in weight. In addition, discontinuation of combination contraceptives because of weight gain did not differ between groups where this was studied., Authors' Conclusions: Available evidence was insufficient to determine the effect of combination contraceptives on weight, but no large effect was evident.

Background: Combination injectable contraceptives provide a highly effective, reversible method of preventing pregnancy, and they do not require daily administration or use at the time of coitus. Although they are used in many countries, their acceptability could be limited by method characteristics, such as the need to obtain a monthly injection or bleeding pattern changes., Objectives: To assess the contraceptive efficacy, bleeding patterns, discontinuation, user preferences, and side effects of combination injectable contraceptives., Search Strategy: We searched computerized databases for randomized controlled trials of combination injectable contraceptives., Selection Criteria: Randomized controlled trials reported in any language were eligible if they compared a combination injectable with any other contraceptive method (e.g., a second combination injectable contraceptive, progestin-only injectable contraceptive, other hormonal contraceptive or barrier method) or placebo. We limited the review to currently marketed combination injectable contraceptives., Data Collection and Analysis: The primary reviewer evaluated all titles and abstracts from the literature searches to determine their eligibility. Two reviewers independently extracted data from the eligible trials. Data on contraceptive efficacy, bleeding patterns, continuation, and side effects were entered and analyzed with RevMan 4.2., Main Results: Combination injectable contraceptives include depot medroxyprogesterone acetate (DMPA) 25 mg plus estradiol cypionate (E(2)C) 5 mg, as well as norethisterone enanthate (NET-EN) 50 mg plus estradiol valerate (E(2)V) 5 mg. These combination injectable contraceptives resulted in lower rates of early study discontinuation due to amenorrhea or other bleeding problems, but had higher rates of discontinuation due to other reasons than the progestin-only comparison contraceptives. Studies comparing two combination injectable contraceptives found that NET-EN 50 mg plus E(2)V 5 mg resulted in less overall early discontinuation and less discontinuation due to amenorrhea or prolonged bleeding than DMPA 25 mg plus E(2)C 5 mg. However, these differences were not detected in all trials making this comparison. The NET-EN plus E(2)V group also had more cyclical (regular) bleeding and fewer prolonged bleeding reference periods than the DMPA plus E(2)C group. The groups did not differ in their amenorrhea rates., Authors' Conclusions: While discontinuation rates can be viewed as a measure of method acceptability, the findings should be interpreted with caution since discontinuation rates are dependent on many other factors. Future research should be directed toward interventions to improve the acceptability of combination injectable contraceptives, such as providing injections in settings more convenient than clinical sites, methods for women to administer their own injections, and counseling about possible bleeding pattern changes.

Background: The avoidance of menstruation through extended or continuous administration (greater than 28 days of active pills) of combination oral contraceptives (COCs) has gained legitimacy through its use in treating endometriosis, dysmenorrhea, and menstruation-associated symptoms. Avoidance of menstruation through continuous use of COCs for reasons of personal preference may have additional advantages to women, including improved compliance, greater satisfaction, fewer menstrual symptoms, and less menstruation-related absenteeism from work or school., Objectives: To determine the differences between COCs dosed continuously (greater than 28 days of active pills) compared with traditional cyclic dosing (21 days of active pills and 7 days of placebo). Our hypothesis was that continuously administered COCs have equivalent efficacy and safety but improved bleeding profiles, amenorrhea rates, adherence, continuation, participant satisfaction, and menstrual symptoms compared with cyclic COCs., Search Strategy: We searched computerized databases (Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, POPLINE, LILACS) for trials using continuous or extended COCs during the years 1966 to 2005. We also searched the references in review articles and publications identified for inclusion in the protocol. Investigators were contacted regarding additional references., Selection Criteria: All randomized controlled trials in any language comparing continuous (greater than 28 days of active pills) versus traditional cyclic administration (21 days of active pills and 7 days of placebo) of COCs for contraception., Data Collection and Analysis: Titles and abstracts identified from the literature searches were assessed for potential inclusion. Data were extracted onto data collection forms and then entered into RevMan 4.2. Peto odds ratios with 95% confidence intervals were calculated for all outcomes for dichotomous outcomes. Weighted mean difference was calculated for continuous outcomes. The trials were critically appraised by examining the following factors: study design, blinding, randomization method, group allocation concealment, exclusions after randomization, loss to follow-up, and early discontinuation. Because the included trials did not have a standard treatment (type of pill and time length for continuous dosing), we could not aggregate data into meta-analysis., Main Results: Six randomized controlled trials met our inclusion criteria. Study findings were similar between 28-day and extended cycles in regard to contraceptive efficacy (i.e., pregnancy rates) and safety profiles. When compliance was reported, no difference between 28-day and extended cycles was found. Participants reported high satisfaction with both dosing regimens, but this was not an outcome universally studied. Overall discontinuation and discontinuation for bleeding problems were not uniformly higher in either group in most studies. The few studies that reported menstrual symptoms found that the extended cycle group fared better in terms of headaches, genital irritation, tiredness, bloating, and menstrual pain. Five out of the six studies found that bleeding patterns were either equivalent between groups or improved with continuous-dosing regimens. Endometrial lining assessments by ultrasound were done in a small number of participants but all endometrial stripe measurements were less than 5 mm., Authors' Conclusions: Evidence from existing randomized control trials comparing COCs given continuously (greater than 28 days of active pills) to traditional monthly cyclic dosing (21 days of active pills and 7 days of placebo) is of good quality. However, the variations in type of pill and time length for continuous dosing make direct comparisons between regimens impossible. Future studies should choose a previously described type of pill and dosing regimen. More attention needs to be directed towards participant satisfaction and menstruation-associated symptoms.

Background: Concern about estrogen-related adverse effects has led to progressive reductions in the estrogen dose in combination oral contraceptives (COCs). However, reducing the amount of estrogen to improve safety also could result in decreased contraceptive effectiveness and unacceptable changes in bleeding patterns., Objectives: To test the hypothesis that COCs containing 20 mcg in terms of contraceptive effectiveness, bleeding patterns, discontinuation, and side effects., Search Strategy: We searched computerized databases (CENTRAL, MEDLINE, EMBASE, and POPLINE) from their inception to November 2003, searched the references of eligible trials, and wrote to oral contraceptive manufacturers to identify eligible trials., Selection Criteria: English-language reports of randomized controlled trials that compare a COC containing 20 mcg EE were eligible. We excluded studies where the interventions were designed to be administered for less than three consecutive cycles or to be used primarily as treatment for non-contraceptive conditions. Trials had to report on contraceptive effectiveness, bleeding patterns, trial discontinuation due to bleeding-related reasons or other side effects, or side effects to be included in the review., Data Collection and Analysis: The primary reviewer evaluated all titles and abstracts located in the literature searches to determine whether they met the inclusion criteria. Two reviewers independently extracted data from the studies identified for inclusion. We wrote to the authors when clarifications or additional data were needed. Data were entered and analyzed with RevMan 4.2., Main Results: No differences were found in contraceptive effectiveness for the 11 COC pairs for which this outcome was reported. Several COCs containing 20 mcg EE resulted in higher rates of early trial discontinuation (overall and due to adverse events such as irregular bleeding) as well as increased risk of bleeding disturbances (both amenorrhea/infrequent bleeding and irregular, prolonged, frequent bleeding, or breakthrough bleeding or spotting) than their higher-estrogen comparison pills., Authors' Conclusions: While COCs containing 20 mcg EE may be theoretically safer, this review did not focus on the rare events required to assess this hypothesis. Data from randomized controlled trials are inadequate to detect possible differences in contraceptive effectiveness. Low-dose estrogen COCs resulted in higher rates of bleeding pattern disruptions. However, most trials compared COCs containing different progestin types, and changes in bleeding patterns could be related to progestin type as well as estrogen dose.

Background: "Fertility awareness-based methods" (FAB) of family planning "involve identification of the fertile days of the menstrual cycle, whether by observing fertility signs such as cervical secretions and basal body temperature, or by monitoring cycle days. FAB methods can be used in combination with abstinence or barrier methods during the fertile time" (WHO 2000). Several names have been used to describe this approach to contraception, including "rhythm," "natural family planning" and "periodic abstinence." Fertility awareness-based methods can be used with abstinence from sexual intercourse. Alternatively, they can be used with barrier contraceptives or withdrawal during presumed fertile times., Objectives: We retrieved and analyzed all randomized controlled trials that examined any fertility awareness-based methods used for contraception., Search Strategy: We searched the computerized databases Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, POPLINE, EMBASE, and LILACS (each from its inception to January, 2004) for randomized controlled trials of fertility awareness-based methods. We examined the reference list of each trial as well as that of review articles., Selection Criteria: We included all randomized controlled trials in any language that compared any fertility awareness-based methods for contraception with a placebo; another method, including an alternative fertility awareness-based method; or fertility awareness-based methods used in conjunction with another contraceptive., Data Collection and Analysis: We assessed all titles and abstracts found for inclusion. We evaluated the methodological quality of the trials for potential biases by qualitatively assessing the study design; randomization method; allocation concealment; blinding; premature discontinuation rates; and loss to follow-up rates. Because of methodological weaknesses, we could not enter the trial results in RevMan, calculate measures of association, or aggregate data., Main Results: Because of poor methods and reporting, pregnancy rates could not be determined. A trial in Colombia found similar numbers of pregnancies among women randomized to the ovulation and symptothermal methods. In contrast, a companion trial in Los Angeles observed more pregnancies in the group assigned to the ovulation method. In the two U.S. trials, recruitment of participants was unexpectedly difficult; this aspect was not mentioned in the report from Colombia. Continuation rates were poor. In the two larger trials, most participants discontinued their assigned method before entering the observation phase of the trial., Reviewers' Conclusions: The comparative efficacy of fertility awareness-based methods of contraception remains unknown. Despite intensive training and ongoing support, most participants in these trials discontinued prematurely. Contraceptive methods should be properly evaluated, preferably in randomized controlled trials, before adoption and dissemination.

Background: Acne is a common skin disorder among women. Although no uniform approach to the management of acne exists, combination oral contraceptives (COCs), which contain an estrogen and a progestin, often are prescribed for women., Objectives: To determine the effectiveness of COCs for the treatment of facial acne compared to placebo or other active therapies., Search Strategy: We searched the computerized databases Cochrane Skin Group trial register, Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, POPLINE, Biological Abstracts and LILACS for randomized controlled trials of COCs and acne. We wrote to authors of identified trials to seek any unpublished or published trials that we might have missed., Selection Criteria: All randomized controlled trials reported in any language that compare the effectiveness of a COC containing an estrogen and a progestin to placebo or another active therapy for acne in women were eligible., Data Collection and Analysis: We extracted data on total and specific (i.e. open or closed comedones, papules, pustules and nodules) facial lesion counts; acne severity grades; global assessments by the clinician or the participant and discontinuation due to adverse events. Data were entered and analyzed in RevMan 4.2., Main Results: The search yielded five placebo-controlled trials that made three different comparisons and 14 trials that made nine comparisons between two COC regimens. An additional trial compared a COC to an antibiotic. COCs reduced acne lesion counts, severity grades and self-assessed acne compared to placebo. Differences in the comparative effectiveness of COCs containing varying progestin types and dosages, though, were less clear. COCs that contained chlormadinone acetate or cyproterone acetate improved acne better than levonorgestrel although this apparent advantage was based on limited data. A COC with cyproterone acetate might result in better acne outcomes than one with desogrestrel; however, the three studies comparing these COCs produced conflicting results. Likewise, levonorgestrel showed a slight improvement over desogestrel in acne outcomes in one trial, but a second trial found no difference between the COCs., Reviewers' Conclusions: The three COCs evaluated in placebo-controlled trials are effective in reducing inflammatory and non-inflammatory facial acne lesions. Few differences were found in acne effectiveness between COC types. How COCs compare to alternative acne treatments is unknown since limited data were available regarding this question.

Background: Vasectomy is an increasingly popular and effective family planning method. A variety of vasectomy techniques are used worldwide including various vas occlusion techniques (excision and ligation, thermal or electrocautery, and mechanical and chemical occlusion methods), vas irrigation and fascial interposition. Vasectomy guidelines largely rely on information from observational studies. Ideally, the choice of vasectomy techniques should be based on the best available evidence from randomized controlled trials., Objectives: The objective of this review was to compare the effectiveness, safety, acceptability and costs of vasectomy techniques for male sterilization., Search Strategy: We searched the computerized databases the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, Popline and LILACS. In addition, we searched the reference lists of relevant articles and book chapters., Selection Criteria: We included randomized controlled trials and controlled clinical trials comparing vasectomy techniques., Data Collection and Analysis: We assessed all titles and abstracts located in the literature searches and two reviewers independently extracted articles identified for inclusion. Data were presented in the text of the review. Outcome measures include contraceptive efficacy, safety, discontinuation, and acceptability., Main Results: Two trials compared vas occlusion with clips versus a conventional vasectomy technique; both were of poor quality. Neither trial found a difference between the two groups with regard to the primary outcome of failure to reach azoospermia. Four trials examined vas irrigation: three compared water irrigation with no irrigation and one compared water irrigation with euflavine. All of the trials were of poor quality. None of the trials found a significant difference between the groups with respect to the primary outcome of time to azoospermia. However, one trial found that the median number of ejaculations to azoospermia was significantly lower in the euflavine group compared to the water irrigation group. The one trial that compared vasectomy with fascial interposition versus vasectomy without fascial interposition was a high quality, large study that has only been partially reported at the time of this review. The fascial interposition group was significantly more likely to be related to vasectomy success (azoospermia) at 22 weeks. However, fascial interposition also was associated with significantly more surgical difficulties., Reviewers' Conclusions: No conclusions can be made about the effectiveness, safety, acceptability and costs of vas occlusion technique or vas irrigation as studies that examined these were of low quality and underpowered. Fascial interposition is associated with improved vasectomy success but is associated with some increased surgical difficulty. Randomized controlled trials examining other vasectomy techniques were not available. More research is required to examine vasectomy techniques.

Background: The male condom, which consists of a thin sheath placed over the glans and shaft of the penis, is designed to prevent pregnancy by providing a physical barrier against the deposition of semen into the vagina during intercourse. Beginning in the 1990s, nonlatex male condoms made of polyurethane film or synthetic elastomers were developed as alternative male barrier methods for individuals with allergies, sensitivities or preferences that prevented the consistent use of condoms made of latex., Objectives: The review sought to evaluate nonlatex male condoms in comparison with latex condoms in terms of contraceptive efficacy, breakage, slippage, safety and user preferences., Search Strategy: We searched the the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE using PubMed, EMBASE, Popline, and LILACS for randomized controlled trials of nonlatex condoms. The references of eligible publications were assessed for inclusion. We also wrote to the manufacturers of nonlatex condoms and known investigators in an attempt to locate any other published or unpublished trials not identified in our search., Selection Criteria: The review included all randomized controlled trials identified in the literature search that evaluated a male nonlatex condom made of polyurethane film or synthetic elastomers in comparison with a latex condom., Data Collection and Analysis: We evaluated all titles and abstracts located in the literature searches for inclusion in the review. Two reviewers independently extracted data from the identified studies. We entered and analyzed data with RevMan 4.1. Peto odds ratios (ORs) with 95% confidence intervals (CIs) were calculated for the outcomes contraceptive efficacy, condom breakage and slippage, discontinuation of use, safety and user preference. The number of condoms, men, or women was used as the denominator for the ORs. Contraceptive efficacy, early discontinuation, and safety outcomes were also measured with survival analysis techniques and entered into "Additional tables.", Main Results: While the eZ.on condom did not protect against pregnancy as well as its latex comparison condom, no differences were found in the typical-use efficacy in the comparisons between the Avanti and the Standard Tactylon and their latex counterparts. The nonlatex condoms were associated with higher rates of clinical breakage than their latex comparison condoms. The statistically significant odds ratios for clinical breakage for the nonlatex condoms versus their latex comparisons ranged from 2.6 (95% CI: 1.6 to 4.3) to 5.0 (95% CI: 3.6 to 6.8). Few adverse events were reported. In almost all of the comparisons, substantial proportions of participants preferred the nonlatex condom or reported that they would recommend its use to others., Reviewer's Conclusions: Although the nonlatex condoms were associated with higher rates of clinical breakage than their latex comparison condoms, the new condoms still provide an acceptable alternative for those with allergies, sensitivities or preferences that might prevent the consistent use of latex condoms. The contraceptive efficacy of the nonlatex condoms requires more research.

Background: The delivery of combination contraceptive steroids from a skin patch or vaginal ring offers potential advantages over those administered via the traditional oral route. The skin patch and vaginal ring could possibly require a lower dose due to increased bioavailability and improved user compliance., Objectives: The review's objective is to compare the contraceptive efficacy, cycle control, compliance, and safety of the contraceptive skin patch versus combination oral contraceptives and the contraceptive vaginal ring versus combination oral contraceptives., Search Strategy: We searched the computerized databases MEDLINE, Popline, Cochrane Controlled Trials Register, EMBASE, and LILACS for trials of the contraceptive patch or the contraceptive ring. We also searched the references of the publications identified for inclusion. We contacted the manufacturers of the skin patch and the contraceptive ring in an attempt to identify published or unpublished trials that we might have missed., Selection Criteria: All randomized controlled trials in any language comparing the combination contraceptive skin patch with a combination oral contraceptive or the combination contraceptive vaginal ring with a combination oral contraceptive., Data Collection and Analysis: Titles and abstracts identified from the literature searches were assessed for potential inclusion. Data were abstracted by both the primary and second reviewers to ensure accuracy and were entered into RevMan 4.1. Peto odds ratios with 95% confidence intervals were calculated for all outcomes. Six- and 13-cycle Kaplan-Meier pregnancy rates were also entered into "Additional Tables." No sensitivity analyses were conducted since the eligible trials used different comparison oral contraceptives. The trials were critically appraised by examining the following factors: the study design; blinding; randomization method; group allocation concealment; exclusions after randomization; loss-to-follow-up; and early discontinuation., Main Results: We found three trials of the skin patch and no eligible randomized controlled trials of the combination contraceptive vaginal ring. The six-cycle and 13-cycle Kaplan-Meier cumulative probabilities of pregnancy showed that the combination contraceptive skin patch was similar to the control combination oral contraceptive in contraceptive efficacy. One trial found that patch users discontinued early from the trial more often than oral contraceptive users (OR 1.6; 95% CI, 1.3-2.0) but a second trial found no differences in discontinuation between the groups (OR 2.6; 95% CI, 1.0-6.7). Patch users had more self-reported cycles of compliance than oral contraceptive users; the odds ratio of compliance was 2.1 (95% CI, 1.8-2.3). Patch users were more likely to report breast discomfort than oral contraceptive users with an odds ratio of 3.1 (95% CI, 2.3-4.2). The remaining commonly reported adverse events did not differ by group assignment. One trial found that women assigned to use the patch were more likely to discontinue due to adverse events than those assigned to use the oral contraceptive (OR 2.3; 95% CI, 1.6-3.3), but a second trial found no difference (OR 2.8; 95% CI, 0.7-11.3). Few serious adverse events occurred that were considered possibly or likely related to the use of the patch or oral contraceptive., Reviewer's Conclusions: The randomized controlled trials comparing a combination contraceptive skin patch to a combination oral contraceptive showed similar efficacy rates for the two methods. The patch group had better self-reported compliance than the oral contraceptive group. On the other hand, breast tenderness was more common among those randomized to the patch. The patch might lead to early discontinuation (overall and due to adverse events), but the trial results on this outcome were mixed. No conclusions can be drawn regarding the vaginal ring as no eligible trials were available.

Background: Contraception for women who are breastfeeding is a public health issue of global importance. Each year over 100 million women make decisions about beginning or resuming contraception after childbirth. These decisions include both the choice of contraceptive method and the time at which its use begins, both of which continue to be debated by experts. Choices of contraception may be limited for lactating women due to concerns about hormonal effects on quality and quantity of milk, passage of hormones to the infant, and infant growth. Ideally, the contraceptive method chosen should not interfere with lactation. Additionally, because the return of menstruation and ovulation can be unpredictable in breastfeeding women, the timing of contraception initiation is important., Objectives: To determine the effect of combined oral contraceptives and progestin-only contraceptives on lactation. The a priori hypothesis is that combined oral contraception impairs lactation, making it less appropriate than progestin-only or nonhormonal contraception for breastfeeding women., Search Strategy: We used PUBMED, POPLINE, EMBASE, LILACS, and Cochrane Controlled Trials Register computer searches, supplemented by review articles and contact with investigators., Selection Criteria: We sought all randomized controlled trials, reported in any language, that included any form of hormonal contraception compared with another form of hormonal contraception, nonhormonal contraception, or placebo during lactation. Hormonal contraception could include combined oral or injectable contraceptives, progestin-only oral or injectable contraceptives, hormonal implants, or hormonal intrauterine devices. Study participants included breastfeeding women of any age or parity who desired contraception., Data Collection and Analysis: We evaluated the methodological quality of each report and sought to identify duplicate reporting of data from multicenter trials. We abstracted data onto data collection forms. Principal outcome measures included quantity of milk; biochemical analysis of milk composition; initiation, maintenance and duration of lactation; infant growth; efficacy of contraceptive method while breastfeeding; and timing of contraception initiation and its effects on lactation. Because the trials did not have uniform interventions, often lacked quantifiable outcomes, and had poor methodological quality, we could not aggregate the data in a meta-analyses., Main Results: Seven reports from five randomized controlled trials met our inclusion criteria. Most of the five trials did not specify their method used to generate a random sequence, method of allocation concealment, blinding of treatments, or use of an intention-to-treat analysis. Additionally, high loss to follow-up rates invalidated at least two studies. The findings from two reports comparing oral contraceptives to placebo during lactation were conflicting. Another trial found no inhibitory effects on lactation from progestin-only contraceptives. Finally, the WHO trial found no effect of progestin-only contraceptives on lactation but a decline in breast milk volume from combination contraceptives during lactation. High loss to follow-up rates, however, undermine the credibility of the WHO trial. No significant differences in infant growth or weight appeared in any of the included trials as a result of the use of hormonal contraception during lactation., Reviewer's Conclusions: Evidence from randomized controlled trials on the effect of hormonal contraceptives during lactation is limited and of poor quality; results should be interpreted with caution. The existing randomized controlled trials are insufficient to establish an effect of hormonal contraception, if any, on milk quality and quantity. Evidence is inadequate to make recommendations regarding hormonal contraceptive use for lactating women. At least one properly conducted randomized controlled trial of adequate size is urgently needed to address this question.

Background: Weight gain is often attributed as a side effect of combination hormonal contraceptive, and many women and clinicians believe that an association exists. Concern about weight gain can limit the use of this highly effective method of contraception by deterring the initiation of its use and causing early discontinuation among users. Nevertheless, a causal relationship between combination contraceptives and weight gain has not been established., Objectives: The aim of the review was to evaluate the association between combination contraceptive use and changes in weight., Search Strategy: We searched the computerized databases MEDLINE, Popline, CENTRAL, EMBASE, and LILACS for studies of combination contraceptives. We also wrote to known investigators and manufacturers to request information about other published or unpublished trials not discovered in our search., Selection Criteria: All English-language, randomized controlled trials at least three treatment cycles in duration that compared a combination contraceptive to a placebo or with a combination contraceptive that differed in drug, dosage, regimen, and/or study length were eligible., Data Collection and Analysis: All titles and abstracts located in the literature searches were assessed. Data were entered and analyzed with RevMan 4.1, and a second reviewer verified the data entered. Depending on the data available, the weighted mean difference using a fixed effects model with 95% confidence intervals was calculated for the mean change in weight between baseline and post-treatment measurements or the Peto odds ratio with 95% confidence intervals was calculated using the proportion of women who gained or lost more than a specified amount of weight., Main Results: The three placebo-controlled, randomized trials did not find evidence supporting a causal association between combination oral contraceptives or a combination skin patch and weight gain. Most comparisons of different combination contraceptives showed no substantial difference in weight. In addition, discontinuation of combination contraceptives because of weight gain did not differ between groups where this was studied., Reviewer's Conclusions: Available evidence is insufficient to determine the effect of combination contraceptives on weight, but no large effect is evident.

Background: Women with preterm labor that is arrested with tocolytic therapy are at increased risk of recurrent preterm labor. Terbutaline pump maintenance therapy has been given to such women to decrease the risk of recurrent preterm labor, preterm birth, and its consequences., Objectives: To determine the effectiveness and safety of terbutaline pump maintenance therapy after threatened preterm labor in preventing preterm birth and its complications., Search Strategy: We searched the Cochrane Pregnancy and Childbirth Group trials register (searched May 2002) and the Cochrane Controlled Trials Register (Cochrane Library Issue 2, 2002)., Selection Criteria: Randomized trials comparing terbutaline pump maintenance therapy with alternative therapy, placebo, or no therapy after threatened preterm labor., Data Collection and Analysis: Two reviewers independently assessed the studies for inclusion and then extracted data from eligible studies., Main Results: We included two studies. Terbutaline pump maintenance therapy did not appear to offer any advantages over the saline placebo pump or oral terbutaline maintenance therapy in preventing preterm births by prolonging pregnancy or its complications among women with arrested preterm labor. The weighted mean difference (WMD) for gestational age at birth was -0.1 weeks (95% confidence interval (CI) -1.7 to 1.4) for terbutaline pump therapy compared with saline placebo pump for both trials combined and 1.4 weeks (95% CI -1.1 to 3.9) for terbutaline pump versus oral terbutaline therapy for the first trial. The second trial reported a relative risk (RR) of 1.17 (95% CI 0.79 to 1.73) of preterm birth (less than 37 completed weeks) and a RR of 0.97 (95% CI 0.51 to 1.84) of very preterm birth (less than 34 completed weeks) for terbutaline pump compared with saline placebo pump. Terbutaline pump therapy also did not result in a higher rate of therapy continuation or a lower rate of infant complications. No data were reported on long-term infant outcomes, costs, or maternal assessment of therapy., Reviewer's Conclusions: Terbutaline pump maintenance therapy has not been shown to decrease the risk of preterm birth by prolonging pregnancy. Furthermore, the lack of information on the safety of the therapy, as well as its substantial expense, argues against its role in the management of arrested preterm labor. Future use should only be in the context of well-conducted, adequately powered randomized controlled trials.

Background: The cervical cap and the diaphragm are vaginal barrier contraceptive methods that prevent pregnancy by covering the cervix. The two devices also act as a reservoir for spermicide. The cervical cap is smaller and can remain in place longer than the diaphragm. Two types of cervical caps, the Prentif cap and the FemCap, have been compared to the diaphragm in randomized controlled trials., Objectives: The review seeks to evaluate the contraceptive efficacy, safety, discontinuation, and acceptability of the cervical cap with that of the diaphragm., Search Strategy: We searched MEDLINE, Popline, Cochrane Controlled Trials Register, EMBASE, and LILACS for randomized controlled trials of cervical caps, and we reviewed the references of the included publications. Also, we wrote to the manufacturers and known investigators to request information about any other published or unpublished trials not found in our search., Selection Criteria: All randomized controlled trials in any language comparing a cervical cap with a diaphragm were eligible for inclusion., Data Collection and Analysis: All titles and abstracts located in the literature searches were assessed, and articles identified for inclusion were independently abstracted by two reviewers. Data were entered and analyzed with RevMan 4.1, and a second reviewer verified the data entered. Outcome measures include contraceptive efficacy, safety, discontinuation, and acceptability. Outcomes were calculated as Peto odds ratios with 95 percent confidence intervals using women as the denominators. Life-table and Kaplan-Meier cumulative rate ratios for selected measures were also presented in "Additional Tables.", Main Results: The Prentif cap was comparable to the diaphragm in preventing pregnancy, but the FemCap was not as effective in preventing pregnancy as its comparison diaphragm. The curves for the life-table cumulative pregnancy rates through 24 months for the Prentif cap and the diaphragm were not statistically significantly different (p-value of 0.39). However, the six-month Kaplan-Meier cumulative pregnancy rates for the FemCap and the diaphragm did not meet the a priori definition of clinical equivalence. The Prentif cap had a higher proportion of Class I to Class III cervical cytologic conversions at the three-month visit than the diaphragm; the odds ratio was 2.3 (95% CI, 1.0-5.1). The FemCap trial did not find differences in Papanicolaou smear results between the cap and diaphragm groups. Prentif cap users had a lower odds ratio of vaginal ulcerations or lacerations (0.3; 95% CI, 0.1-0.7) than diaphragm users. FemCap users had a higher odds ratio of blood in the device on removal (2.3; 95% CI, 1.3-4.1), but a lower odds ratio of urinary tract infections (0.6; 95% CI, 0.4-1.0) than those in the diaphragm group. In the FemCap trial, similar proportions of women reported liking their assigned device "somewhat" or "a lot" at the two-week interview. However, FemCap users were less likely than the diaphragm users to state that they were "probably" or "definitely" likely to use the device alone after completing the trial (odds ratio of 0.5; 95% CI, 0.3-0.7) or that they would recommend it to a friend (odds ratio of 0.5; 95% CI, 0.3-0.8)., Reviewer's Conclusions: The Prentif cap was as effective as its comparison diaphragm in preventing pregnancy, but the FemCap was not. Both cervical caps appear to be medically safe.

Background: The contraceptive vaginal sponge was developed as an alternative to the contraceptive diaphragm. The sponge, made of polyurethane impregnated with nonoxynol-9 (1g), releases 125 mg of the spermicide over 24 h of use. Unlike the diaphragm, the sponge can be used for more than one coital act within 24 h without the insertion of additional spermicide, and the sponge does not require fitting or a prescription from a physician. How the sponge compares with the diaphragm in terms of efficacy and continuation is not clear., Objectives: To compare the efficacy and continuation rates of the sponge compared with the diaphragm (used with nonoxynol-9 as a spermicide). Our a priori hypothesis was that the sponge would have a higher failure rate and higher discontinuation rates than the diaphragm., Search Strategy: We searched the computerized databases MEDLINE, EMBASE, Popline, LILACS, and the Cochrane Controlled Trials Register. In addition, we searched the reference lists of all potentially relevant articles and book chapters. We also contacted investigators involved with both trials identified to seek other published or unpublished trials., Selection Criteria: We included randomized controlled trials comparing the vaginal contraceptive sponge (Today; Collatex) with any diaphragm used with nonoxynol-9 to prevent pregnancy., Data Collection and Analysis: We examined the studies identified through the literature searches for possible inclusion and evaluated their methodological quality using the Cochrane guidelines. We contacted an author involved with both published trials for supplementary information about randomization and allocation concealment. We entered data into RevMan 4.1 and calculated Peto odds ratios for overall pregnancy and 12-month discontinuation using numbers of women as the denominator. We also abstracted 12-month cumulative life-table ratios for these same outcomes, but were unable to aggregate these data., Main Results: The sponge was statistically significantly less effective in both trials in preventing overall pregnancy than was the diaphragm. The 12-month cumulative life-table termination rates per 100 women for overall pregnancy were 17.4 for the sponge versus 12.8 for the diaphragm in the larger U.S. trial and 24.5 for the sponge and 10.9 for the diaphragm in the U.K. trial. Similarly, discontinuation rates at 12 months were higher with the sponge than with the diaphragm (odds ratio 1.3; 95% CI 1.1-1.6). Allergic-type reactions were more common with the sponge in both trials, although the frequency of discontinuation for discomfort differed in the two trials., Reviewer's Conclusions: The sponge was less effective than the diaphragm in preventing pregnancy. Discontinuation rates were higher at 12 months as well. Other randomized controlled trials will be needed to resolve the role of spermicides in preventing sexually transmitted infections or in causing adverse effects.