drugset / Trial / NCT02693418
Duration of Effect of Acidform Gel on Vaginal pH
Phase 1
Completed
105 enrolled
Evofem Inc.
Clinical Research Management, Inc. · collabJohns Hopkins University · collabMetroHealth Medical Center · collab
RandomizedParallel-groupDouble-blindPrevention
Summary
The objective of this study was to determine the magnitude and duration of the reduction in pH (acidification) following a single dose of Acidform vaginal gel containing 3, 4, or 5 g compared with hydroxyethylcellulose placebo gel (4 g) or no treatment. Vaginal pH was measured 1 h, 6 h, 12 h, 24 h, then once daily for 7 days. In addition, the participants were assessed for an exploratory endpoint to the determine effect of one dose of Acidform gel (3, 4 or 5 g) or placebo gel (4 g) or no treatment, on asymptomatic bacterial vaginosis (BV).
Timeline
- Start
- 2016-08-24
- Primary completion
- 2016-12-12
- Completion
- 2016-12-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Acidform | Unknown | 3 g | Other |
| Subject | Acidform | Unknown | 4 g | Other |
| Subject | Acidform | Unknown | 5 g | Other |
Indications
No indication recorded.