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Objective: To assess efficacy and safety of a single-dose vaginal clindamycin gel for bacterial vaginosis treatment.Methods: We conducted a double-blind, placebo-controlled, randomized study comparing clindamycin gel with placebo (2:1 ratio). Entry required clinical diagnosis of bacterial vaginosis, that is, all four Amsel's criteria, without other genital infections. Nugent scores of 7-10 were required for efficacy assessment, per updated 2019 U.S. Food and Drug Administration guidance. Patients were evaluated at screening, day 7-14, and day 21-30 (test of cure). Clinical cure was defined as resolution of three of four Amsel's criteria. Bacteriologic cure was defined as Nugent score lower than 4. Therapeutic cure was both clinical and bacteriologic cure. Primary outcome was clinical cure at the test-of-cure visit. Secondary endpoints were clinical cure at day 7-14, and bacteriologic and therapeutic cures at day 7-14 and test of cure. A sample size of 188 patients in the clindamycin group compared with 94 patients in the placebo group had 90% power to detect statistically significant difference (P=.05, 2-tailed).Results: Participants were seen between July 9, 2020, and November 12, 2020. Of 307 randomized women, 56.0% were Black and 88.3% reported one or more previous bacterial vaginosis episodes. In the modified intention-to-treat population, 70.5% of patients in the clindamycin group and 35.6% in the placebo group achieved clinical cure at test of cure (primary outcome) (difference of 34.9, 95% CI 19.0-50.8), as did 77.5% of patients in the clindamycin group and 42.6% of patients in the placebo group in the per-protocol population (difference of 34.9, 95% CI 17.0-52.7). Statistically significant differences between groups were seen for all secondary endpoints. Clinical cure rate in patients in the clindamycin group with more than three bacterial vaginosis episodes in the prior year was 70.0%. Approximately 15% (15.3%) of patients in the clindamycin group experienced one or more treatment-emergent adverse events related to study treatment, as did 9.7% of patients in the placebo group. The most frequent treatment-related, treatment-emergent adverse event was vulvovaginal candidiasis.Conclusion: A new, single-dose clindamycin vaginal gel was highly effective, with excellent safety, in women disproportionately affected by bacterial vaginosis, with Nugent scores of 7-10 at study entry.Funding Source: The study was funded by Daré Bioscience, Inc.Clinical Trials Registration: ClinicalTrials.gov, NCT04370548. [ABSTRACT FROM AUTHOR]

Menopause signifies permanent cessation of ovarian function and the end of a woman's reproductive potential. Menopausal transition plays a major role in many symptoms common in middle age and may contribute to chronic conditions and disorders of aging. An evidence-based plan of care improves outcomes, enhancing quality of life. [ABSTRACT FROM AUTHOR]

Abstract: Intravaginal boric acid (IBA) represents one of the only options available to treat azole-resistant vulvovaginal candidiasis (VVC) and is included as part of multiple national guidelines (including the United Kingdom and the United States) for the treatment of VVC or recurrent bacterial vaginosis. Novel products using IBA are under development for treatment and suppression of VVC and bacterial vaginosis. Use of over-the-counter or clinician-prescribed IBA in reproductive-aged women is already widespread and may increase further if drug resistance in VVC rises. However, IBA is not a Food and Drug Administration-approved drug, and safety data are sparse. Given these factors, it is important to understand the currently available data on the safety of IBA use. Herein, we set out to synthesize human and animal data (converting, where appropriate, dose and serum values to standard units to facilitate comparison) to answer 2 key questions: (1) What are the data on the safety of IBA use for women? and (2) What are the data on the safety of IBA use in pregnancy? We find that, despite gaps, available data suggest IBA use is safe, at least when used in doses commonly described in the literature as being prescribed by clinicians. Information on harms in pregnancy is limited, and data remain insufficient to change current guidelines, which recommend IBA avoidance in pregnancy. [ABSTRACT FROM AUTHOR]

Background: Recurrence of bacterial vaginosis (RBV) is a major challenge to effective therapy. Women experiencing intractable and frequent recurrences are ill-served by available treatment options, such as both antimicrobial and use of probiotics.Methods: One hundred five women with RBV failing all recommended regimens seen in the clinic were prescribed combination oral nitroimidazole 500 mg twice a day for 7 days and simultaneous boric acid 600 mg daily per vagina therapy for 30 days; thereafter, they were prescribed twice-weekly vaginal metronidazole gel for 5 months in an attempt to prevent recurrence and followed by a 6-month observation period. Results reflect standard of clinic care in this uncontrolled retrospective cohort analysis.Results: An initial regimen of nitroimidazole and simultaneous but prolonged vaginal boric acid achieved a satisfactory response (BV cure ≤2 Amsel criteria) in 92 of 93 available patients. Thereafter, a maintenance metronidazole gel prevented symptomatic BV recurrence in 69.6% of compliant patients at 6-month follow-up. Long-term cure at a 12-month follow-up was demonstrated in almost 69% of women reaching the 6-month observation phase. Vaginal candidiasis frequently complicated prolonged antibiotic prophylaxis requiring frequent antifungal rescue or prophylaxis. Frequent loss to follow-up in this long-term study influenced efficacy evaluation.Conclusions: In the absence of new antimicrobials or proven probiotic regimens, women with RBV may benefit from a prolonged drug-intensive antimicrobial regimen incorporating antibiofilm activity until newer measures are available. Additional randomized, control studies are needed. [ABSTRACT FROM AUTHOR]

Objective: To compare the effectiveness of cervical pessary to vaginal progesterone for the prevention of preterm birth in women with twin pregnancies and short cervix.Methods: This randomized controlled trial was conducted at My Duc Hospital, Vietnam. Asymptomatic women with twin pregnancies and cervical length less than 38 mm were randomized to Arabin pessary or vaginal progesterone (400 mg once a day) group. The primary outcome was preterm birth at less than 34 weeks of gestation. Secondary outcomes were adverse maternal and perinatal complications. We planned a subgroup analysis according to quartile of cervical length. Analysis was conducted on an intention-to-treat basis. We estimated that the primary outcome would occur in 28.4% of women treated with progesterone. Thus a total sample size of 290 women divided equally into two groups was required to detect a 14% absolute risk difference in the primary outcome between the two groups (power 80%, alpha-error 5%, 10% loss to follow-up).Results: Between March 2016 and June 2017, we randomized 300 women, 150 women in each group. Preterm birth at less than 34 weeks of gestation occurred in 24 (16%) women in the pessary group and 33 (22%) women in the progesterone group (relative risk [RR] 0.73, 95% CI 0.46-1.18). The use of pessary significantly reduced the composite of poor perinatal outcomes (19% vs 27%; RR 0.70, 95% CI 0.43-0.93). In women with cervical length of 28 mm or less (25th percentile), pessary significantly reduced the preterm birth rate at less than 34 weeks of gestation from 46% (16/35) to 21% (10/47) (RR 0.47, 95% CI 0.24-0.90) and significantly improved the composite of poor perinatal outcomes.Conclusion: Cervical pessary and 400 mg vaginal progesterone resulted in similar rates of preterm birth at less than 34 weeks of gestation in women with twin pregnancies and cervical length less than 38 mm.Clinical Trial Registration: ClinicalTrials.gov, NCT02623881. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the association of institutional protocols for vaginal preparation with antiseptic solution and the surgical site infection rate in women undergoing cesarean delivery during labor.Methods: This is a secondary analysis of a multicenter randomized controlled trial of adjunctive azithromycin prophylaxis for cesarean delivery performed in laboring patients with viable pregnancies. The primary outcome for this analysis was the rate of superficial or deep surgical site infection within 6 weeks postpartum, as per Centers for Disease Control and Prevention criteria. Maternal secondary outcomes included a composite of endometritis, wound infection or other infections, postoperative maternal fever, length of hospital stay, and the rates of hospital readmission, unexpected office visits, and emergency department visits.Results: A total of 523 women delivered in institutions with vaginal antisepsis policies before cesarean delivery and 1,490 delivered in institutions without such policies. There was no difference in superficial and deep surgical site infection rates between women with and without vaginal preparation (5.5% vs 4.1%; odds ratio [OR] 1.38, 95% CI 0.87-2.17), even after adjusting for possible confounders (adjusted OR 0.86, 95% CI 0.43-1.73). The lack of significant benefit was noted in all other maternal secondary outcomes.Conclusion: Institutional policies for vaginal preparation before cesarean delivery were not associated with lower rates of surgical site infection in women undergoing cesarean delivery during labor. [ABSTRACT FROM AUTHOR]

For women at elevated risk of thrombosis, clinicians are challenged to relieve menopausal symptoms without increasing the risk of thrombosis. Oral menopausal hormone therapy increases the risk of venous thromboembolism by 2-fold to 3-fold. Observational studies suggest less thrombotic risk with transdermal therapies and with progesterone over synthetic progestogens (progestins), but the data are limited. Beneficial nonpharmacologic therapies include cognitive behavioral therapy and clinical hypnosis, whereas beneficial nonhormonal pharmacologic therapies include selective serotonin reuptake inhibitors and serotonin-norepinephrine reuptake inhibitors. For treatment of the genitourinary syndrome of menopause, vaginal lubricants and moisturizers, low-dose vaginal estrogen, and intravaginal dehydroepiandrosterone are options. [ABSTRACT FROM AUTHOR]

Objective: To examine success rates of 5-fluorouracil, excision, and laser ablation as the initial and secondary management strategies for women with high-grade vaginal intraepithelial neoplasia.Methods: We conducted a retrospective case series of women referred to a single center for management of biopsy-proven, high-grade vaginal intraepithelial neoplasia between April 1994 and May 2016. Data including demographic characteristics, human papillomavirus risk factors, antecedent Pap cytology, concurrent or prior cervical and vulvar dysplasia, and treatment outcome including follow-up Pap cytology were recorded. All women were counseled on options of excision, laser ablation, or 5-fluorouracil, which was administered intravaginally according to a standardized regimen. Recurrence was defined as a biopsy showing any vaginal intraepithelial neoplasia diagnosis after primary treatment.Results: Forty-seven patients were treated initially with 5-fluorouracil, 35 were treated with excision, and 22 were treated with laser ablation. Demographics were similar between groups. No recurrence was noted in 35 women treated with 5-fluorouracil (74%; 95% CI 62-87%), 20 treated with excision (57%; 95% CI 41-74%), and nine treated with laser ablation (41%; 95% CI 20-61%). Among 13 patients treated with 5-fluorouracil for recurrence, eight (62%) did not experience a second recurrence. Nine of 58 (16%) patients ever treated with 5-fluorouracil reported a side effect, most commonly irritation and dyspareunia.Conclusion: 5-fluorouracil was associated with a 74% success rate as the initial treatment modality for high-grade vaginal dysplasia. There is also a role for 5-fluorouracil in the management of recurrent or persistent high-grade vaginal intraepithelial neoplasia. [ABSTRACT FROM AUTHOR]

The article examines the impact of cancer and cancer treatment on the sexual health of women. It explores the contribution of cancer treatments on changes in vaginal tissues due to suppression of ovarian function. Also discussed are barriers to sexual health assessment, methods in minimizing pain during vaginal penetration and the subjective component of arousal.

Objective: To assess the efficacy of progestogens for maintenance tocolysis in women undelivered after their first preterm labor episode.Methods: Women with singleton pregnancies between 22 0/7 and 31 6/7 weeks of gestation with arrested preterm labor and a cervical length 25 mm or less at hospital discharge were eligible. Patients with a previous preterm birth were excluded. In a randomized controlled trial conducted in five university hospitals, women were randomized to receive vaginal progesterone (200 mg per day) or intramuscular 17α-hydroxyprogesterone caproate (341 mg per week) or to an observation groups (control group). The primary outcome was the proportion of women with preterm birth at less than 37 weeks of gestation. A sample size of 160 per group (n=480) was planned to compare vaginal progesterone and 17α-hydroxyprogesterone caproate groups with those in the control group. The sample size estimation was based on the hypothesis that the risk of experiencing preterm birth in the control group would be 30% and that 17α-hydroxyprogesterone caproate or progesterone would decrease this risk to 15%. A P value of <.025 was defined as statistically significant. At planned interim analysis (n=254), the trial was stopped for futility.Results: Between July 2010 and June 2015, 257 women were eligible and 254 were subsequently randomly assigned to vaginal progesterone (n=86), 17α-hydroxyprogesterone caproate (n=87), or observation (n=81). Nineteen (8%) were excluded from the analysis because they either dropped out or information was missing, leaving 235 women available for analysis. Demographic characteristics were similar across groups. The preterm birth rate did not differ significantly between groups: 23% in the 17α-hydroxyprogesterone caproate group, 39% in the vaginal progesterone group, and 22% in the women in the control group (P=.949 for 17α-hydroxyprogesterone caproate compared with the women in the control group and P=.027 for vaginal progesterone compared with women in the control group).Conclusion: The use of progestogens for maintenance tocolysis in women with a short cervix did not reduce the rate of preterm birth.Clinical Trial Registration: ClinicalTrials.gov, NCT01178788. [ABSTRACT FROM AUTHOR]

Objective: To estimate the effect of lidocaine-prilocaine cream on patient pain at the time of office pessary removal and reinsertion.Methods: In this double-blind, randomized placebo-controlled trial, participants undergoing routine pessary care in a urogynecology office at a tertiary referral center were randomized to application of 4 g of either lidocaine-prilocaine or placebo cream 5 minutes before pessary change. Visual analog scale pain scores were collected from the patient at baseline, after pessary removal, and after pessary reinsertion. Physicians also recorded their estimate of patient pain at pessary removal and reinsertion. The primary outcome was the participant-reported visual analog scale pain score at the time of pessary removal and reinsertion. A sample size of 26 per group (n=52) was planned to estimate an absolute mean difference in visual analog scale pain of 2.1 cm at the time of pessary removal. An analysis of covariance was used to evaluate pain at removal and reinsertion as a function of treatment assignment controlling for baseline pain.Results: From July 2015 through February 2016, 116 women were screened and 54 were recruited: 28 in the lidocaine-prilocaine cream group and 26 in the placebo group. One patient in the lidocaine-prilocaine cream group was later withdrawn owing to vaginal erosion. The participants were all postmenopausal women, with an average age of 77.8 years. Most characteristics were similar between groups. After adjusting for baseline pain, participants randomized to the lidocaine-prilocaine group had lower pain at pessary removal when compared with those assigned to placebo (mean difference=-2.05, 95% confidence interval -3.69 to -0.41; P=.015).Conclusion: Lidocaine-prilocaine cream use at the time of office pessary removal reduces patient-reported pain. Clinicians may wish to include this simple intervention to optimize patient comfort and compliance.Clinical Trial Registration: ClinicalTrials.gov, NCT02380742. [ABSTRACT FROM AUTHOR]

Objective: To evaluate whether adding oxytocin to preinduction cervical ripening with a Foley catheter increases the rate of delivery within 24 hours.Methods: This was a randomized, multicenter, parallel trial of women with a singleton pregnancy at 24 weeks of gestation or greater undergoing labor induction. Women were randomly allocated to an intracervical Foley catheter followed by oxytocin or Foley with concurrent oxytocin infusion. Nulliparous and multiparous women were randomized and analyzed separately based on parallel design. The primary outcome was Foley placement to delivery at 24 hours or less. A sample size of 100 nulliparous women and 75 multiparous women per group would be required to detect a 20% increase in baseline 24-hour delivery rate with 80% power for each parity group.Results: From January 2015 through July 2016, 323 patients were enrolled: 184 nulliparous women and 139 multiparous women. Nulliparous women who received concurrent Foley and oxytocin delivered more frequently within 24 hours of Foley placement than did the Foley followed by oxytocin group (64% compared with 43%, P=.003, relative risk 1.51, 95% confidence interval [CI] 1.14-2.00). Multiparous women who received concurrent Foley and oxytocin delivered more frequently within 24 hours than the Foley followed by oxytocin group (87% compared with 72%, relative risk 1.22, 95% CI 1.02-1.45). Median time to delivery was shorter in both nulliparous women (20.9 compared with 26.1 hours, P<.001) and in multiparous women, (14.9 compared with 18.6 hours, P=.01) who received concurrent Foley and oxytocin compared with Foley followed by oxytocin. There were no significant differences in the rates of cesarean delivery, postpartum hemorrhage, chorioamnionitis, or neonatal intensive care unit admission between the randomization groups.Conclusion: Induction with concurrent oxytocin infusion added to Foley significantly increases the rate of delivery within 24 hours in both nulliparous and multiparous compared with Foley followed by oxytocin.Clinical Trial Registration: ClinicalTrials.gov, https://clinicaltrials.gov/, NCT02273115. [ABSTRACT FROM AUTHOR]

Objective: To evaluate cervical pessary as an intervention to prevent preterm birth in twin pregnancies with a short cervix.Methods: This was a retrospective cohort study of twin pregnancies managed by a single maternal-fetal medicine practice from 2005 to 2015. We included patients at 28 weeks of gestation or less who were diagnosed with a cervical length less than 20 mm. At the time of diagnosis, all patients were prescribed vaginal progesterone. Starting in 2013, they were also offered pessary placement in addition to vaginal progesterone. We compared outcomes between patients who received a pessary and matched women in a control group in a one-to-three ratio. Women in the control group were matched to women in the case group according to cervical length and gestational age (within 5 mm and 1 week, respectively, of the case patient at the time of pessary placement). We excluded patients with cerclage, monochorionic-monoamniotic placentation, major fetal congenital anomalies discovered before or after birth, patients with twin-twin transfusion syndrome, and patients for whom there were no appropriate controls. Chi-square, Fisher exact, and Student's t tests were used, as appropriate. Regression analysis was performed to control for significant differences at baseline.Results: Twenty-one patients received a cervical pessary, and they were compared with 63 matched women in the control group. As expected (as a result of matching), baseline gestational age (25.7±2.1 compared with 25.9±2.1 weeks of gestation, P=.671) and cervical length (10.9±3.6 mm compared with 11.9±4.5 mm, P=.327) were similar between the groups. Patients with a pessary had a significantly lower incidence of delivery at less than 32 weeks of gestation (1/21 [4.8%] compared with 18/63 [28.6%], adjusted P=.05), longer interval to delivery (65.2±16.8 compared with 52.1±24.3 days, adjusted P=.025), and a lower incidence of severe neonatal morbidity (2/21 [9.5%] compared with 22/63 [34.9%], adjusted P=.04).Conclusion: For twin pregnancies with a short cervix, the addition of a cervical pessary to vaginal progesterone is associated with prolonged pregnancy and reduced risk of adverse neonatal outcomes. A large randomized trial should be performed to verify these retrospective findings. [ABSTRACT FROM AUTHOR]

Objectives: Our objectives were to assess physician knowledge of costs of products, tests, and services commonly used by obstetrician/gynecologists (OB/GYNs) and identify those items that could be eliminated without decreasing quality of care by performing a prospective observational pilot study.Methods: An anonymous electronic survey was distributed to 70 OB/GYN providers at Greenville Memorial Hospital. Survey items included common laboratory tests, medications, and clinical services. The survey was used to identify items with high cost for which there were less costly but equally efficacious alternatives. As an educational intervention, grand rounds reviewing the survey results, as well as recommendations that would allow for lean healthcare changes, were conducted. Utilization and cost savings were tracked for a 1-year preintervention and a 1-year postintervention.Results: In total, 50 of 70 providers (71%) completed the survey. Hydrocortisone acetate/pramoxine hydrochloride and dinoprostone vaginal inserts were targeted for intervention. Use of the dinoprostone vaginal insert decreased 50.5% with a savings of $66,500 when comparing the preintervention period with the postintervention period. Use of hydrocortisone acetate/pramoxine hydrochloride decreased 90% with a savings of $92,655. Combined, the decreased use of these products led to a $159,155 cost savings in the 1-year postintervention period.Conclusions: OB/GYN providers at our institution had a poor working knowledge of costs. Through the use of a survey and educational intervention, we demonstrated that simple interventions could lead to high-quality, lean healthcare changes. [ABSTRACT FROM AUTHOR]

Objective: To examine the prevalence, predictors, and effects of nocturia in women and evaluate overlaps with established urinary tract disorders.Methods: This was a cross-sectional analysis of 2,016 women, aged 40 years and older, recruited from Kaiser Permanente Northern California from 2008 to 2012. Nocturia and other urinary symptoms were assessed using structured interviewer-administered questionnaires. Nocturia was defined as patient-reported nocturnal voiding of two or more times per night over a typical week.Results: Thirty-four percent (n=692) reported nocturia, and 40% of women with nocturia reported no other urinary tract symptom. Women with nocturia were older (mean age 58 compared with 55 years) (odds ratio [OR] per 5-year increase 1.21, 95% confidence interval [CI] 1.12-1.31), more likely black (45%) (OR 1.75, 95% CI 1.30-2.35) or Latina (37%) (OR 1.36, 95% CI 1.02-1.83) compared with non-Latina white (30%), have worse depression (mean Hospital Anxiety and Depression Scale score 3.8 compared with 2.8) (OR per 1-point increase in Hospital Anxiety and Depression Scale score 1.08, 95% CI 1.04-1.12), and worse mobility (mean Timed Up-and-Go 11.3 compared with 10 seconds) (OR per 5-second increase in Timed Up-and-Go 1.29, 95% CI 1.05-1.58). Nocturia occurred more among women with hysterectomy (53% compared with 33%) (OR 1.78, 95% CI 1.08-2.94), hot flushes (38% compared with 32%) (OR 1.49, 95% CI 1.19-1.87), and vaginal estrogen use (42% compared with 34%) (OR 1.50, 95% CI 1.04-2.18).Conclusion: Nocturia is common in women and not necessarily attributable to other urinary tract disorders. Factors not linked to bladder function may contribute to nocturia risk, underlining the need for multiorgan prevention and treatment strategies.Level Of Evidence: II. [ABSTRACT FROM AUTHOR]

Background: In preparation for a randomized controlled trial (RCT), we conducted a pilot RCT of the acceptability and feasibility of diaphragms and candidate vaginal microbicide for sexually transmitted infection prevention among high-risk women in Madagascar.Methods: Participants were randomized to four arms: (1) diaphragm (worn continuously) with Acidform applied in the dome; (2) diaphragm (worn continuously) with placebo gel hydroxyethylcellulose (HEC) in the dome; (3) HEC applied intravaginally before sex; (4) Acidform applied intravaginally before sex. All women were given condoms. Participants were followed weekly for 4 weeks. We fit unadjusted negative binomial regression models with robust variance estimators to generate the proportion of sex acts with casual partners where condoms and experimental study products were used.Results: Retention was 98% among 192 participants. Experimental product use with casual partners was high, reported in 85%, 91%, 74%, and 81% of sex acts for women in the Acidform-diaphragm, HEC-diaphragm, HEC-alone, and Acidform-alone arms, respectively. However, the proportion reporting product use during 100% of acts with casual partners over the full follow-up period was much lower: 28% to 29% in the gel-diaphragm arms and 6% to 10% in gel-alone arms. Women used condoms in 62% to 67% of sex acts with casual partners, depending on the randomization arm. Participants found diaphragms easy to insert (97%) and remove (96%). Acidform users (with or without the diaphragm) reported more genitourinary symptoms than HEC users (14% vs. 5% of visits).Conclusions: A sexually transmitted infection prevention RCT of candidate microbicide with and without the diaphragm appears acceptable and feasible in this population. [ABSTRACT FROM AUTHOR]

The article discusses a study of Finnish women aged above 50 years which evaluated whether the risk of estrogen-only therapy on breast cancer varies by dose, constituent, and route of administration. It notes two to three extra cases of breast cancer per 1,000 women for orally or transdermally administered estradiol for five years or more. No risks of breast cancer were associated with oral estradiol use for less than five years, oral estradiol, or vaginal estrogens.

Background: Frequent use of some vaginal formulations can induce mucosal irritation. Therefore, it is important to evaluate their vaginal tolerance.Goal: The goal of this study was to optimize the mucosal irritation test using slugs for the evaluation of the local tolerance of vaginal gels and investigate the relevance of the test.Study Design: The irritation potential of the gels was assessed by the amount of mucus produced during a repeated 30-minute contact period. Membrane damage was estimated from the release of proteins and enzymes. After optimization of the procedure, the local tolerance of several vaginal gels was evaluated.Results: Hydroxyethyl cellulose gel induced no irritation, because the mucus production and the protein release were low and no enzyme release was detected. Replens and K-Y jelly resulted in an increased mucus production; however, no increased protein and no enzyme release were detected. The nonoxynol-9-containing gels Protectaid, Advantage S, and Conceptrol caused a higher mucus production and an increased protein release and/or enzyme release, indicating severe irritation.Conclusion: The mucosal irritation test using slugs can be used for local tolerance testing of vaginal formulations. [ABSTRACT FROM AUTHOR]

Background and Objective: Because microbicides will be applied topically in the vagine, the active agent must be formulated as a gel or cream by combining the active agent with suitable excipients. Although a number of in vitro methods have been developed for testing anti-HIV activity of microbicides, most of these methods have not been used for testing microbicides as a gel or cream. Goal: The goal of this study was to measure anti-HIV activity of marketed vaginal gel or cream products and excipients. Study Design: A PBMC-based in vitro method has been developed for the evaluation of anti-HIV activity of gel or cream marketed products and formulated drug delivery systems. This method includes viral exposure to test compounds follwoed by differential centrifugation and filtration. Results: Using this methodology, a number of marketed vaginal products showed 83% to 100% inactivation of a variety of X4 and R5 HIV of different clades. Cell viability as determiend by the MTT assay for all marketed products was greater than 90%. Some of the excipients also showed anti-HIV activity (20-90%) of their own. Conclusion: This knowledge of baseline anti-HIV activity of vaginal products (cream/gel) and excipients is useful for the final formulation and development of anti-HIV microbicides. [ABSTRACT FROM AUTHOR]

OBJECTIVE:To estimate the effectiveness of vaginal hydrocortisone suppositories in the treatment of vulvovaginal lichen planus.METHODS:A nonprobability sample of 60 patients diagnosed with vulvovaginal lichen planus were treated with intravaginal hydrocortisone 25-mg suppositories (1–1/2) twice a day. The dose was tapered to two times a week dosing after several months to maintain symptom-free disease. The participants’ charts were reviewed and pretreatment symptoms and physical examination were compared to posttreatment symptoms and physical examination. Data were analyzed using McNemar χ2.RESULTS:The sample population included mostly white (86.7%) patients with a mean age of 58 years. Forty-three participants had complete data with follow-up subjectively and objectively after treatment. Most symptoms (eg, vulvar burning, pruritis, dyspareunia, vaginal discharge) were improved and the improvement was found to be statistically significant. Sexual activity was unchanged in the women. Additionally, most physical findings by examination (eg, erythema, erosions, vulvar and vaginal lesions) were improved and the improvement was found to be statistically significant. Vaginal stenosis did not significantly improve. Treatment was continued in 35 patients with a mean duration of 28.1 months. There was overall improvement in 81% subjectively and in 76.8% objectively.CONCLUSION:Intravaginal hydrocortisone suppositories are an effective treatment for vulvovaginal lichen planus. [Copyright &y& Elsevier]

Objective: To identify signs and the etiology of occult bladder injury during the tension-free vaginal tape sling procedure.Method: The charts of 140 women who underwent a tension-free vaginal tape procedure were reviewed, and complications were tabulated and analyzed. The tension-free vaginal tape procedure was performed in six fresh-frozen pelves to demonstrate the mechanism of the occult bladder injury.Results: Occult bladder injury was suspected when cystoscopy instillation fluid flowed from the plastic sheath that covers the prolene tape after the extraction of the tension-free vaginal tape trocar. Three of six cases of intraoperative bladder injury had occult bladder injury identified on repeat cystoscopic inspection. The bladder injury caused by the rough edge at the point of attachment of the tension-free vaginal tape to the trocar was reproducible in three of 12 tension-free vaginal tape applications in fresh-frozen pelves. Traction on the tension-free vaginal tape reapproximates the injured bladder edges and potentially promotes spontaneous healing.Conclusion: Bladder injuries may go unrecognized during a tension-free vaginal tape procedure. Continuous seepage of water through the prolene plastic sleeve is suggestive of occult bladder injury and requires repeat cystoscopy to identify the potential site of injury. [ABSTRACT FROM AUTHOR]

OBJECTIVE:To determine whether empiric treatment with vaginal metronidazole in women with atypical squamous cells of undetermined significance (ASCUS) on Papanicolaou smear increases the number of cases that regress to normal on repeated cytologic studies.METHODS:A randomized double-masked trial was designed to compare women with ASCUS on screening Papanicolaou smear who received vaginal metronidazole, 37.5 mg twice daily, or placebo gel twice daily, for 5 days. Normalization of repeated Papanicolaou smear at 3 months was the primary end point. Regression to normal between the two groups was compared by χ2 analysis. Power analysis required 45 women per study arm to demonstrate a 50% improvement in regression to normal among the metronidazole-treated women, at α = 0.05 and 80% power.RESULTS:One hundred and six tubes of gel were dispensed, 54 metronidazole and 52 placebo. Eighty-four women (79%) returned for repeated cytologic examination at a mean of 6.5 months. Overall, 50 women (60%) had normal findings on repeated cytologic examination, and 34 (40%) had persistent abnormal findings. Twenty-two women had repeated ASCUS, and 11 had squamous intraepithelial lesions (SIL) on repeated cytologic examination. Regression to normal was found in 22 (54%) metronidazole-treated women and 28 (65%) placebo recipients. The number of cases of repeated ASCUS (31% versus 25%) or SIL (15% versus 10%) were similar between the two groups.CONCLUSIONS:Empiric vaginal metronidazole does not improve the management of women with ASCUS on Papanicolaou smear and should be discouraged. [Copyright &y& Elsevier]

In small clinical trials, dehydroepiandrosterone (DHEA) has been found to relieve symptoms associated with postmenopausal conditions and infertility in women. DHEA may provide a cost-effective alternative to typical hormone therapies. Because of a lack of long-term and large-scale studies, only intravaginal DHEA supplementation is approved and recommended for treatment. Further investigation of DHEA supplementation is needed and encouraged to determine its safety and effectiveness. [ABSTRACT FROM AUTHOR]

The article presents a study which assesses the efficacy of retreatment with same medication for early treatment failure in women with bacterial vaginosis. There were 104 women who had complete clinical data, of which 51 had an early treatment failure. It cites that women who were cured after retreatment did not differ in attributes from those who were not cured. It says that patients can be advised that retreatment with same medication provides high clinical cure and treatment.

The authors describe a case of naturally occurring heterotopic pregnancy in a 30-year-old woman treated with ultrasonographically guided transvaginal injection of potassium chloride (KCI), which subsequently required surgery for abdominal bleeding. Concerns about the advisability of the treatment are highlighted by a review of literature which revealed that 55 percent of tubal heterotopic pregnancies treated with KCI injection required subsequent salpingectomy.

Background: Lactobacillus crispatus is a part of the normal vaginal microflora of humans.Goal: The goal of this study was to assess whether a capsule containing an H2O2-producing strain of L crispatus (CTV-05) would alter the vaginal microflora and/or epithelial tissues when applied intravaginally in the pig-tailed macaque model.Study Design: Ten sexually mature female Macaca nemestrina were assessed at baseline for quantitative vaginal microbiology and vaginal pH and with colposcopy. One capsule containing 108 colony forming units of desiccated L crispatus CTV-05 was inserted into the vaginal fornix of each animal. Vaginal assessments were repeated on days 1 and 2 after capsule insertion. The L crispatus CTV-05 strain was identified with use of a DNA fingerprinting method.Results: Before product use, four of 10 animals had detectable levels of H2O2-producing lactobacilli. L crispatus CTV-05 was detected in 1 of 10 animals on day 1 and in 3 of 10 animals on day 2 following insertion of the capsule. There were no tissue changes observed by colposcopy. Vaginal pH decreased in two animals colonized by CTV-05, from 7.0 at baseline to 4.5+/-0.5 on days 1 and 2 after product use.Conclusions: A single intravaginal application of capsules containing 108 L crispatus CTV-05 resulted in vaginal colonization in three of 10 animals 2 days after use. The absence of colposcopic changes in the vagina/cervical tissues indicates that L crispatus capsules are well tolerated. [ABSTRACT FROM AUTHOR]

This section offers news briefs on the U.S. pharmaceutical industry as of January 2018. The Food and Drug Administration (FDA) has launched the FDA Adverse Events Reporting System (FAERS) Public Dashboard, an interactive web-based tool about adverse drug events. The FDA has approved Yescarta, a chimeric antigen receptor (CAR)-T cell therapy. A study affirmed the safety of the use of vaginal estrogen creams or suppositories for post-menopausal women.

According to this study: Active treatment with either vaginal estradiol tablets or vaginal moisturizer provided no additional benefit over placebo in women with postmenopausal vulvovaginal symptoms. Many women can be treated with a nonprescription vaginal lubricating gel. [ABSTRACT FROM AUTHOR]

The article discusses drug Prasterone vaginal insert introduced to treat sexual intercourse pain of women with postmenopause.

The article reports the technique and long-term outcome of the treatment of heterotopic pregnancy using a conservative approach. Two such cases were treated by transvaginal ultrasound-guided aspiration of the gestational sacs followed by injection of hyperosmolar glucose. The ectopic pregnancies resolved, and the intrauterine pregnancies resulted in live births by cesarean delivery. The authors describe the treatment modality as simple and inexpensive.

The article discusses the medication errors of several drugs formulation including the Cervidil, Prostin E2 and digoxin immune fab (DigiFab). It promotes the use of Cervidil rather than the Prostin E2 for cervical ripening in pregnant women. It also notes that the pharmacy administered a correct formulation of the drugs into the patients.