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A novel vaginal pH regulator: results from the phase 3 AMPOWER contraception clinical trial.

ABSTRACT: Objective:The objective was to evaluate the contraceptive effectiveness, safety, and acceptability of a novel vaginal pH regulator over seven cycles of use. Study design:A single-arm, open-label, phase 3 study was conducted across 112 sites in the United States in sexually active 18-35-year-old women at risk of pregnancy. Women administered the study treatment ? 1?h before each episode of intercourse. Women recorded use of study drug, coital information, and any symptoms experienced in electronic diaries. The primary outcome was the seven-cycle cumulative pregnancy rate as calculated using the Kaplan-Meier methodology; secondary outcomes included safety. Overall satisfaction was assessed via written questionnaires. Results:A total of 1384 women were enrolled in the study from July 2017 to November 2018. Mean age was 27.7?±?4.4?years; most women were white (69.0%). The seven-cycle cumulative pregnancy percentage was 13.7% [95% confidence interval (CI): 10.0%-17.5%], meeting the prespecified primary endpoint of having the upper bound 95% CI ? 21%. Most common adverse events (AEs) occurring in ? 2% of women were vulvovaginal burning sensation, vulvovaginal pruritus, urinary tract infection, vulvovaginal pain, mycotic infection, bacterial vaginosis, and nasopharyngitis. Of 1330 women who used the study drug at least once, fewer than 2% of women discontinued due to any AEs, and < 1% of women discontinued due to genitourinary symptoms. Overall, > 80% of women reported being "very satisfied" or "satisfied" with study treatment. Conclusions:In this phase 3 study, the novel vaginal pH regulator demonstrated 86.3% contraceptive effectiveness, was safe and well tolerated, and was highly acceptable. Implications:This novel vaginal pH regulator is a safe, nonhormonal, woman-controlled method of contraception that expands women's options.

SUBMITTER: Thomas MA

PROVIDER: S-EPMC7358659 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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A novel vaginal pH regulator: results from the phase 3 AMPOWER contraception clinical trial.

Thomas Michael A MA Chappell B Todd BT Maximos Bassem B Culwell Kelly R KR Dart Clint C Howard Brandon B

Contraception: X 20200701

<h4>Objective</h4>The objective was to evaluate the contraceptive effectiveness, safety, and acceptability of a novel vaginal pH regulator over seven cycles of use.<h4>Study design</h4>A single-arm, open-label, phase 3 study was conducted across 112 sites in the United States in sexually active 18-35-year-old women at risk of pregnancy. Women administered the study treatment ≤ 1 h before each episode of intercourse. Women recorded use of study drug, coital information, and any symptoms experienc ...[more]

PMID: 32685920

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Project description:ObjectivesThere have been conflicting reports of altered vaginal microbiota and infection susceptibility associated with contraception use. The objectives of this study were to determine if intrauterine contraception altered the vaginal microbiota and to compare the effects of a copper intrauterine device (Cu-IUD) and a levonorgestrel intrauterine system (LNG-IUS) on the vaginal microbiota.Study designDNA was isolated from the vaginal swab samples of 76 women using Cu-IUD (n=36) or LNG-IUS (n=40) collected prior to insertion of intrauterine contraception (baseline) and at 6 months. A third swab from approximately 12 months following insertion was available for 69 (Cu-IUD, n=33; LNG-IUS, n=36) of these women. The V4 region of the bacterial 16S rRNA-encoding gene was amplified from the vaginal swab DNA and sequenced. The 16S rRNA gene sequences were processed and analyzed using the software package mothur to compare the structure and dynamics of the vaginal bacterial communities.ResultsThe vaginal microbiota from individuals in this study clustered into 3 major vaginal bacterial community types: one dominated by Lactobacillus iners, one dominated by Lactobacillus crispatus and one community type that was not dominated by a single Lactobacillus species. Changes in the vaginal bacterial community composition were not associated with the use of Cu-IUD or LNG-IUS. Additionally, we did not observe a clear difference in vaginal microbiota stability with Cu-IUD versus LNG-IUS use.ConclusionsAlthough the vaginal microbiota can be highly dynamic, alterations in the community associated with the use of intrauterine contraception (Cu-IUD or LNG-IUS) were not detected over 12 months.ImplicationsWe found no evidence that intrauterine contraception (Cu-IUD or LNG-IUS) altered the vaginal microbiota composition. Therefore, the use of intrauterine contraception is unlikely to shift the composition of the vaginal microbiota such that infection susceptibility is altered.

Dataset Information

A novel vaginal pH regulator: results from the phase 3 AMPOWER contraception clinical trial.

Publications

A novel vaginal pH regulator: results from the phase 3 AMPOWER contraception clinical trial.

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