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Over the past 50 years, pessary use has increased in popularity and has become an essential pelvic organ prolapse (POP) management tool. However, evidence is lacking to define care standardization, including pessary fitting, routine maintenance, and management of pessary-related complications. This clinical consensus statement (CCS) on vaginal pessary use and management for POP reflects statements drafted by content experts from the American Urogynecologic Society and Society of Urologic Nurses and Associates. The purpose of this CCS is to identify areas of expert consensus and non-consensus regarding pessary fitting, follow-up, and management of pessary complications to improve the safety and quality of care where evidence is currently limited. The American Urogynecologic Society and Society of Urologic Nurses and Associates' vaginal pessary for POP writing group used a modified Delphi process to assess statements that were evaluated for consensus after a structured literature search. A total of 31 statements were assessed and divided into 3 categories: (1) fitting and follow-up, (2) complications, and 3) quality of life. Of the 31 statements that were assessed, all statements reached consensus after 2 rounds of the Delphi survey. This CCS document hopefully serves as a first step toward standardization of pessary care, but the writing group acknowledges that improved research will grow the base of knowledge and evidence providing clinicians a foundation to manage pessary care effectively and confidently. [ABSTRACT FROM AUTHOR]

Objective: To determine whether vaginal progesterone for programmed endometrial preparation is noninferior to intramuscular progesterone in terms of live birth rates from frozen embryo transfer (FET).Design: Three-armed, randomized, controlled noninferiority trial.Setting: Multicenter fertility clinic.Patient(s): A total of 1,346 volunteer subjects planning vitrified-warmed transfer of high-quality nonbiopsied blastocysts were screened, of whom 1,125 subjects were ultimately enrolled and randomly assigned to treatment.Intervention(s): The subjects were randomly assigned to receive, in preparation for FET, 50 mg daily of intramuscular progesterone (control group), 200 mg twice daily of vaginal micronized progesterone plus 50 mg of intramuscular progesterone every third day (combination treatment), or 200 mg twice daily of vaginal micronized progesterone.Main Outcome Measure(s): The primary outcome was live birth rate per vitrified-warmed embryo transfer. The secondary outcomes were a positive serum human chorionic gonadotropin test 2 weeks after FET, biochemical pregnancy loss, clinical pregnancy, clinical pregnancy loss, total pregnancy loss, serum luteal progesterone concentration 2 weeks after FET, and patient's experience and attitudes regarding the route of progesterone administration, on the basis of a survey administered to the subjects between FET and pregnancy test.Result(s): A total of 1,060 FETs were completed. The live birth rate was significantly lower in women receiving only vaginal progesterone (27%) than in women receiving intramuscular progesterone (44%) or combination treatment (46%). Fifty percent of pregnancies in women receiving only vaginal progesterone ended in miscarriage.Conclusion(s): The live birth rate after vaginal-only progesterone replacement was significantly reduced, due primarily to an increased rate of miscarriage. Vaginal progesterone supplemented with intramuscular progesterone every third day was noninferior to daily intramuscular progesterone, offering an effective alternative regimen with fewer injections.Clinical Trial Registration Number: NCT02254577. [ABSTRACT FROM AUTHOR]

Vulvovaginal atrophy (VVA) is a progressive condition commonly seen in postmenopausal women. The cessation of ovarian estrogen secretion and a fall in serum levels of dehydroepiandrosterone (DHEA), the remaining source of estrogens and androgens, are thought to promote the development of VVA in this population. Intravaginal prasterone (Intrarosa®) is a synthetic form of DHEA indicated for the treatment of VVA in postmenopausal women presenting with moderate to severe symptoms in the EU; prasterone is also approved in the USA for the treatment of dyspareunia due to menopause. Approval for the treatment of VVA was based on the results of the phase III ERC-231 and -238 trials in which intravaginal prasterone 6.5 mg/day significantly improved the signs and symptoms of VVA (as assessed by the percentage of parabasal and superficial cells, vaginal pH and the severity of dyspareunia) compared with placebo. The beneficial effects of prasterone were also evident during 52 weeks' treatment in the phase III ERC-230 safety trial. Prasterone was generally well tolerated, with the most common treatment-emergent adverse event being application site discharge. During 52 weeks of treatment with prasterone, changes in serum concentrations of estrogenic and androgenic metabolites of DHEA increased from baseline but remained within the normal postmenopausal ranges. Thus, intravaginal prasterone is an effective and generally well-tolerated option for the treatment of VVA in postmenopausal women. [ABSTRACT FROM AUTHOR]

Objective: This study aimed to evaluate improvement of dyspareunia and associated vaginal dryness with a 17β-estradiol softgel vaginal insert (TX-004HR; TherapeuticsMD, Boca Raton, FL, USA) in women with postmenopausal vulvar and vaginal atrophy (VVA). Methods: Postmenopausal women with VVA and moderate to severe dyspareunia received TX-004HR (4, 10, or 25 μg) or placebo in the 12-week, randomized, double-blind, placebo-controlled, phase 3 REJOICE trial. Post hoc analyses examined improvement levels in dyspareunia and concurrent vaginal dryness with TX-004HR and assessed the effects of patient characteristics on vaginal dryness treatment. Results: Significantly more women treated with TX-004HR (all doses) than placebo had complete resolution or substantial improvement in dyspareunia or vaginal dryness (concurrent with dyspareunia) by 12 weeks, observed as early as week 2 with most doses. TX-004HR significantly improved both dyspareunia and vaginal dryness at least one level versus placebo by week 12 in women with both symptoms. Subgroup analyses showed TX-004HR improved vaginal dryness associated with dyspareunia regardless of age, body mass index, uterine status, prior pregnancy, and vaginal birth number. Conclusion: TX-004HR provided clinically meaningful improvements in dyspareunia and vaginal dryness associated with dyspareunia in postmenopausal women with VVA. Clinicians may be able to use this information when discussing patients' expectations regarding symptom improvement with the estradiol vaginal insert. [ABSTRACT FROM AUTHOR]

Background: Multipurpose prevention technologies (MPTs) are being developed to simultaneously protect women from unintended pregnancy and sexually transmitted infections (STIs) or human immunodeficiency virus. This study aims to determine MPT characteristics desired by young women in the United States (U.S.). Materials and Methods: This is a cross-sectional national survey administered online by MTurk. Eligibility criteria included female sex, age 18–29 years, U.S. residence, and sexual activity with a male partner in the past 3 months. MPT characteristics were rated for importance. Odds ratios were generated to explore associations between demographics, sexual behaviors, and prior contraceptive use and likelihood of using various MPT formulations. Results: Of 835 women, the largest proportion reported being likely to use MPTs in the form of injectables (45.6%), followed by vaginal gels (33.7%), vaginal rings (26.3%) and diaphragms (17.3%). Women with prior experience using a specific method of contraception appeared more likely to try an MPT of the same form. Women concerned about STIs and unwanted pregnancy, or with a history of such undesirable outcomes, expressed higher likelihood of use for a broad range of products. Women indicated that safety and efficacy at preventing pregnancy were the most important product characteristics when choosing an MPT. Conclusions: MPTs in the form of injectables are most highly desired, but many women would use vaginal methods, highlighting the importance of developing different delivery methods. Women desire safety and emphasize contraceptive efficacy over infection prevention. MPT preferences must be considered during product development to promote future acceptance among young women in the U.S. [ABSTRACT FROM AUTHOR]

Purpose: To evaluate how physicians in the United States (US) screen for, define, and treat a short cervix to prevent preterm birth.Methods: This was a cross-sectional, web-based survey of 500 physicians treating pregnant patients with a short cervix in the US. Respondents' geographic region was monitored to ensure balance across the nine US Census divisions.Results: Respondents were predominantly obstetrician/gynecologists (86%, 429/500; mean age 49 years). Physicians reported that a median of 90% of their pregnant patients undergo cervical length screening; 81% (407/500) use transvaginal ultrasound. Physicians consult multiple evidence sources to inform their patient care, most commonly clinical guidelines (83%; 413/500) and published research (70%; 349/500). Most physicians (98%; 490/500) reported treating pregnant patients with a short cervix; 95% (474/500) use synthetic and/or natural progestogen, alone or in combination with other treatment modalities. If reimbursement was not a concern, 47% of physicians (230/500) would choose vaginal progesterone as their preferred treatment to prevent preterm birth in all patients with a short cervix, and 45% (218/500) would choose a synthetic progestogen.Conclusion: US guidelines recommend transvaginal ultrasound for cervical length screening; 81% of physicians in this study reported using this method. Most physicians surveyed use progestogens to treat a short cervix, with approximately half choosing a synthetic progestin (45%) and half choosing natural progesterone (47%) as their preferred treatment, despite national guidelines recommending only vaginal natural progesterone for this indication. Additional physician education is required to implement current and best practices. [ABSTRACT FROM AUTHOR]

The MTN-008 trial was the first multi-dose study conducted to evaluate the safety of a microbicide gel (2:1 randomized to tenofovir 1% or hydroxycellulose (HEC) placebo gel) during pregnancy. The study aim was to evaluate safety, tolerability and pharmacokinetics of the study products. Procedures included daily gel administration, with Day 0 and Day 6 in clinic, and Days 1–5 at home. Because pregnancy may pose unique challenges to consistent gel use and acceptability, evaluation of adherence and acceptability was a secondary objective of the trial. The study enrolled healthy, HIV-negative, pregnant women aged 18–40 in Pittsburgh, PA and Birmingham, AL, USA in 2 consecutive groups: cohort 1 was 37–39 weeks gestation, cohort 2 was 34–36 weeks. Ninety-one women completed the study (45 and 46 in each cohort, respectively) and were evaluable per protocol. Adherence was evaluated using self-reports: participants completed a web-based computer-assisted self-interview (CASI) at Days 0 and 6 about gel attitudes and behaviors. At Day 6 trained research staff conducted a short interviewer-administered questionnaire with both structured and open-ended questions. Frequencies of quantitative data were tabulated in SAS and descriptive statistics are presented; open-ended textual data were summarized by a behavioral scientist experienced in qualitative analysis. Participants reported generally neutral perceptions of gel characteristics. A small number of women (7–8%) reported pain (6/90), other physical discomfort (7/90), or mental discomfort (7/90) associated with the process of applicator insertion. About 5% reported the same for the gel itself. Two-thirds (61/90) thought the gel was runny, many complained of bothersome gel leakage and several cited this reason for not inserting a full dose. The majority were not worried the gel would cause problems for their pregnancy or babies. Ninety-seven percent (83/86) said they would use the gel in the future if they were pregnant, and 90% (81/90) when nonpregnant. Self-reported adherence was high with 88% (79/90) reporting daily gel use on both the computerized and interviewer-administered questionnaires. The majority (67/90) reported no difficulty with daily use. However, drug was undetectable (<0.31 ng/mL) among 45% (27/60; 95% CI 32–58%) of the women on active product prior to observed dosing at Day 6. The most common reason for reported nonuse (N = 6) was forgetting. Study gel was generally acceptable, but many complained of a runny consistency (61/90) and leakage (83/90). No frequent or strong concerns about the effects of the study gel on the pregnancy/fetus were reported. Self-reported adherence to study gel self-administered at home for 5 days was high, however plasma drug levels suggest actual use may have been considerably lower. Findings from this study can provide insights relevant to use of other antiretroviral-based, vaginally-inserted HIV prevention methods during pregnancy. [ABSTRACT FROM AUTHOR]

Objectives: To prospectively describe the decline in serum human chorionic gonadotropin (hCG) in the first 5 days after complete medical abortion and evaluate the influence of initial hCG and gestational duration.Study Design: We conducted a prospective, physiologic study of women ≤63 days gestation who underwent medical abortion with 200 mg mifepristone and 800 mcg buccal misoprostol. We stratified enrollment into two gestational cohorts, <49 days and 49-63 days, to ensure gestational variability. We collected serum quantitative hCG values on Day 1 (day of mifepristone), Day 3, Day 5 and a routine follow up hCG on Days 7-14. We calculated the percent hCG decline from Day 1 to each repeat measure and evaluated trends based on initial serum hCG level and gestation.Results: We enrolled 66 women; 59 were protocol-adherent and included in our analysis. Mean gestation on Day 1 was 49 days and mean baseline hCG was 72,332 IU. Fifty-seven subjects (97%) had a complete medical abortion without further intervention. The mean serum hCG decline among subjects with complete medical abortion was 70.0±10.6% [range 36.9-98.6%] on Day 3 and 91.4±4.4% [range 68.4-97.7%] on Day 5. The mean serum hCG decline from Day 1 to routine follow-up on Days 7-9 was 97.1±1.7% [range 92.4-99.2%], from Day 1 to Day 10-11 was 98.5±1.4% [range 94.7-99.6%] and from Day 1 to Day 12-14 was 98.7±2.8% [range 86.7-99.9%]. There was no difference in percent hCG decline stratified by initial hCG or gestation.Conclusions: There is a rapid and predictable decline in serum hCG as early as Day 5 after complete medical abortion through 63 days gestation. Rate of hCG decline is not affected by initial hCG or gestational duration.Implications: For women who require confirmation of complete abortion sooner than 1 week after mifepristone, due to patient preference, logistical constraints or in the setting of pregnancy of unconfirmed location, a single repeat hCG on Day 5 may be clinically useful. [ABSTRACT FROM AUTHOR]

Objectives: The aim of the study was to assess the extent to which misoprostol alters mucosal or systemic immune responses following either buccal or vaginal administration.Methods: This was a prospective, crossover pilot study of 15 healthy, reproductive-age women. Women first received 800 μg misoprostol either via buccal or vaginal administration and were crossed over 1 month later to receive the drug via the other route. Cervicovaginal lavage samples, cervical Cytobrush samples, cervicovaginal swabs, urine and blood were obtained immediately prior to drug administration and the following day. Parameters assessed included urine and cervicovaginal misoprostol levels, whole blood cytokine responses (by ELISA) to immune stimulation with lipopolysaccharide, peripheral blood and cervical lymphocyte phenotyping by flow cytometry, cervicovaginal antimicrobial peptide measurement by ELISA and vaginal microbial ecology assessment by 16S rRNA sequencing.Results: Neither buccal nor vaginal misoprostol significantly altered local or systemic immune and microbiological parameters.Conclusion: In this pilot study, we did not observe significant alteration of mucosal or systemic immunology or vaginal microbial ecology 1 day after drug administration following either the buccal or vaginal route. [ABSTRACT FROM AUTHOR]

Objective: To compare the efficacy of intramuscular hydroxyprogesterone caproate with that of vaginal progesterone for prevention of recurrent preterm birth.Methods: A prospective randomized controlled trial was conducted at a US tertiary care center between June 1, 2007, and April 30, 2010. Women with singleton pregnancies (16-20 weeks) and a history of spontaneous preterm birth were randomly allocated using a computer-generated randomization sequence to receive either a weekly intramuscular injection of hydroxyprogesterone caproate (250 mg) or a daily vaginal progesterone suppository (100 mg). Participants, investigators, and assessors were not masked to group assignment. The primary outcome was birth before 37 weeks of pregnancy. Per-protocol analyses were performed: participants who completed follow-up were included.Results: Analyses included 66 women given intramuscular progesterone and 79 given vaginal progesterone. Delivery before 37 weeks was recorded among 29 (43.9%) women in the intramuscular progesterone group and 30 (37.9%) in the vaginal progesterone group (P=0.50).Conclusion: Weekly intramuscular administration of hydroxyprogesterone caproate and daily vaginal administration of a progesterone suppository exhibited similar efficacy in reducing the rate of recurrent preterm birth. ClinicalTrials.gov: NCT00579553. [ABSTRACT FROM AUTHOR]

Background: The FDA approved over-the-counter (OTC) use of vaginal antifungals in 1990. Subsequently, a plethora of OTC products have become available to women on drugstore shelves.Objectives: The purpose of this study was to determine the availability of OTC products marketed for the treatment of vaginitis and to determine if their efficacy had been confirmed by published prospective randomized control trials (RCTs).Materials and Methods: The authors chose four retail locations frequented by women seeking vaginitis treatment. All products deemed a viable treatment option were purchased. Results. All intravaginal imidazoles purchased, regardless of treatment duration or active ingredient, were found to be of proven efficacy. We were unable to find an RCT confirming the effectiveness of vaginal anti-itch creams and homeopathic treatments for vaginitis.Conclusion: 45% of products available to women in the feminine hygiene section of the stores surveyed could not be confirmed to be effective for treating infectious vaginitis. [ABSTRACT FROM AUTHOR]

Misoprostol, a prostaglandin E(1) analogue, is widely used in the US and other countries for cervical ripening and labour induction. Its use for these indications is not approved by the US Food and Drug Administration (FDA). The manufacturer of misoprostol issued a letter to American healthcare providers in August 2000, cautioning against the use of misoprostol in pregnant women and citing a lack of safety data for its use in obstetrical practice. The only FDA-approved indication in the product labelling is the treatment and prevention of intestinal ulcer disease resulting from nonsteroidal anti-inflammatory drug use. Multiple trials have proven that when applied vaginally, misoprostol is an effective agent for cervical ripening and labour induction in term pregnancy. The use of oxytocin augmentation is reduced when intravaginal misoprostol is used compared with other agents. Misoprostol use in obstetrics carries the added benefits of temperature stability at room temperature, which is unlike other prostaglandin preparations which require refrigeration or freezing, and reduced cost. However, debate continues regarding the optimal dose, dosage regimen, and route of administration. Uterine contraction abnormalities are often found in association with higher misoprostol doses (50 microg or more) given vaginally or orally. Some trials also indicate increased frequencies of meconium passage, neonatal acidaemia and caesarean delivery for fetal distress in women receiving higher doses of vaginally applied misoprostol. However, most trials fail to demonstrate a significant change in the caesarean delivery rate with the use of misoprostol, although a recent meta-analysis indicated that the use of intravaginal misoprostol is associated with a lowering of the caesarean rate when compared with pooled controls. Low-dose misoprostol (25 microg) is an effective agent for cervical ripening and labour induction when used in a judicious and cautious fashion. There are insufficient data to support the widespread use of oral misoprostol for cervical ripening and labor induction. Some trials suggest that this approach may be effective; however, the ideal dose and administration regimen have yet to be defined. [ABSTRACT FROM AUTHOR]

Background: According to the Centers for Disease Control and Prevention, rates of infection for Chlamydia trachomatis and Neisseria gonorrhoeae are increasing in the United States. EVO100 is an investigational antimicrobial, pH-modulating, vaginal gel with active ingredients L-lactic acid, citric acid, and potassium bitartrate that is being evaluated for the prevention of sexually transmitted infections.Objective: The objective of this phase 2B/3 study was to assess the efficacy and safety of EVO100 for the prevention of chlamydia and gonorrhea.Study Design: AMPREVENCE was a double-blinded, placebo-controlled, multicenter study based in the United States conducted over approximately 16 weeks in women at the age of 18 to 45 years who were at risk of urogenital chlamydia and gonorrhea infection. Enrolled women had been diagnosed as having and treated for chlamydia or gonorrhea ≤16 weeks before enrollment. Women received either EVO100 or placebo vaginal gel and were instructed to apply the study drug immediately before or up to 1 hour before each act of vaginal sexual intercourse. The primary and secondary endpoints were the prevention of urogenital chlamydia and gonorrhea, respectively. Exploratory outcomes include women's overall satisfaction with EVO100.Results: In total, 860 women were randomized 1:1 to receive EVO100 (n=426) or placebo (n=434), and 764 women (EVO100, n=376; placebo, n=388) were documented as using the study drug at least once. Baseline characteristics were similar between treatment arms. Overall, women had a mean age of 27.7 years (standard deviation, 6.9) and body mass index of 28.9 kg/m2 (standard deviation, 8.0). Most women were of White (54.3% [467 of 860]) or African American (41.6% [358 of 860]) race and of non-Hispanic/Latina ethnicity (67.1% [577 of 860]). The chlamydia infection rate in EVO100 users was 4.8% (14 of 289) compared with 9.7% (28 of 290) among placebo users (P=.0256), representing a relative risk reduction of 50%. For gonorrhea, the infection rate was 0.7% (2 of 280) in the EVO100 arm compared with 3.2% (9 of 277) in the placebo arm (P=.0316), representing a relative risk reduction of 78%. Increased efficacy was observed with increased adherence, and chlamydia infection rates were significantly reduced with increased adherence in the EVO100 group compared with placebo. Across both arms, there were similar rates of all-cause adverse events (EVO100, 21.3% [80 of 376]; placebo, 20.4% [79 of 388]) and treatment-related adverse events (EVO100, 7.2% [27 of 376]; placebo, 7.5% [29 of 388]). The most common adverse events in the EVO100 arm were vulvovaginal candidiasis (5.1% [19 of 376]), vaginal discharge (3.2% [12 of 376]), and urinary tract infection (3.2% [12 of 376]) and, in the placebo arm, bacterial vaginosis (4.6% [18 of 388]), urinary tract infection (2.6% [10 of 388]), and vaginal discharge (2.6% [10 of 388]). Few women discontinued owing to adverse events in either arm (EVO100, 1.1% [4 of 376]; placebo, 1.5% [6 of 388]). No treatment-related serious adverse events were reported. Most EVO100 users (88%) were satisfied or very satisfied with EVO100 after 16 weeks of use.Conclusion: EVO100 significantly reduced the risk of chlamydia and gonorrhea infections in women at high risk of Chlamydia trachomatis and Neisseria gonorrhoeae infection and was well tolerated, with observed adverse events consistent with its known safety profile. [ABSTRACT FROM AUTHOR]

The article focuses on joint U.S. and South African research findings indicating that the vaginal use of a tenofovir gel by women before and after sex protects against sexually transmitted HIV.

Objective: This study sought to measure residual contraceptive hormone levels in vaginal rings as an adherence marker for monitoring product use in clinical trials.Study Design: Residual etonogestrel and ethinyl estradiol levels from used NuvaRings® of 26 self-reported adherent women enrolled in a clinical trial of vaginal ring acceptability were compared to those from 16 women who used NuvaRing® as their contraceptive choice.Results: Twenty-one (81%) clinical trial rings had contraceptive hormone levels within the range of those used as a contraceptive choice. Five returned rings had unused or discordant levels of residual contraceptive hormones.Conclusion: Residual vaginal ring drug levels could help assess adherence in clinical trials. [ABSTRACT FROM AUTHOR]

The article announces that the U.S. Food and Drug Administration (FDA) has granted Fast Track approval designation for the microbicide tenofovir gel.