Abstract
Purpose of Investigation: To determine change in vaginal pH and duration of change with intravaginal administration of single doses of Amphora vaginal gel (AVG). Materials and Methods: This Phase 1, randomized, placebo-controlled, double-blind, multicenter study included 105 women assigned to AVG 5-gram, AVG 4-gram, AVG 3-gram, placebo gel, or no treatment. Results: AVG at any of the three studied doses significantly lowered vaginal pH compared to placebo or no treatment. The effect was most pronounced in subjects with baseline vaginal pH levels ≥ 5. Peak reduction in vaginal pH with AVG occurred at 12 hours post-administration, with the greatest reduction occurring with the AVG 5-g dose. Subjects in the AVG treatment groups continued to have mean reduction in vaginal pH at Day 7 compared with baseline. Conclusion: Reduction from baseline in vaginal pH with 5-g AVG was significantly greater than with placebo or no treatment and persisted to Day 7 post-treatment.
Highlights
The vaginal microbiome is a highly dynamic environment that is altered with changes in vaginal pH [1, 2]
Disruption of this equilibrium may reduce the presence of Lactobacillus species (LB), which causes a subsequent rise in vaginal pH and possible overgrowth of abnormal flora, since many pathogenic organisms require a pH > 4.5 for growth [8-15]
100 subjects completed the study and five discontinued: three were lost to follow-up and two discontinued due to menses that occurred during the study
Summary
The vaginal microbiome is a highly dynamic environment that is altered with changes in vaginal pH [1, 2]. LB acidify their growth medium to a pH of 3.2 to 4.8, a range that is similar to the average healthy vagina [6, 7] Disruption of this equilibrium may reduce the presence of LB, which causes a subsequent rise in vaginal pH and possible overgrowth of abnormal flora, since many pathogenic organisms require a pH > 4.5 for growth [8-15]. BV has been associated with increased risk of pre-term delivery, low birth weight infants, miscarriage, and acquisition of sexually transmitted infections [17, 18]. Amphora vaginal gel (AVG) is a multipurpose vaginal pH regulator (MVP-R) under evaluation as an on-demand contraceptive (NCT03243305), to prevent certain sexually transmitted infections (NCT03107377), and potentially reduce recurrence of BV after intravaginal administration. The primary objective of this study (NCT02693418) was to assess change from baseline in vaginal pH after intravaginal administration of a single dose (5, 4, or 3 grams) of AVG, placebo gel, or no treatment, and to measure the duration of this change
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