Poster Abstracts
Year: 2021
Type: article
Abstract: Objectives: The Vaginal pH Modulator (VPM; PhexxiⓇ) is a vaginal gel of lactic acid, citric acid, and potassium bitartrate, which maintains an acidic environment even in the presence of alkaline semen. VPM was recently approved for prevention of pregnancy. The objective of the current analysis is to report pooled safety data from the two pivotal phase 3 studies (AMPOWER and AMP001). Methods: AMPOWER was a multicenter, 7-cycle, single-arm, open-label study conducted in the US in women age 18-35 years (NCT03243305). AMP001 was a multicenter, 7-cycle, randomized, open-label study, conducted in the US and Russia in women age 18-45 years, comparing VPM to nonoxynol-9 (NCT01306331). In both AMPOWER and AMP001, women were eligible to enroll if they were healthy, at risk of pregnancy, and desiring contraception. Women administered VPM intravaginally ≤1 hour before each episode of intercourse. Results: In total, 2804 women used VPM at least once and were included in the Safety Population (AMPOWER, n=1,339; AMP001, n=1,465), representing >13,000 cycles of exposure. The percentage of women with ≥1 adverse event (AE) was 52.5% (1,472/2,804), with most women experiencing events of mild/moderate severity (95.6%, 1,407/1,472). A low percentage of women experienced a serious AE or discontinued due to AEs (0.9%, 25/2,804 and 1.6%, 44/2,804, respectively). Overall, the most commonly reported AEs were vulvovaginal burning sensation (16.3%, 458/2,804), vulvovaginal pruritus (12.9%, 363/2,804), vulvovaginal discomfort (7.7%, 217/2,804), and urinary tract infection (7.4%, 207/2,804). Conclusions: In this large, pooled data set, VPM was found to be safe and well-tolerated, consistent with previous reports.
Source: Contraception
Authors: T Lee, K Culwell, C Dart, B Howard
Institution: Progressive Clinical Research
Language: English
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $3,200
OpenAlex ID: W4200344170