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NCT02693418 · ClinicalTrials.gov registry record · Phase 1
Duration of Effect of Acidform Gel on Vaginal pH
A Phase 1 study, sponsored by Evofem.
- Completed
- Registry status
- Phase 1
- Development phase
- 105
- Enrollment target
NCT02693418: Completed Phase 1 study, sponsored by Evofem.
NCT02693418 is a Phase 1 study that has completed, run by Evofem. The registered enrollment target is 105 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02693418, a Phase 1 study, has completed, sponsored by Evofem.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 105 participants
- Enrollment target
Study 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).
Primary Outcome
Vaginal swabs were used to collect samples from the vagina of women dosed with Acidform, HEC placebo, or no treatment. The pH of the samples was measured at pre-determined time points over the course of 7 days.
Interventions
- DRUG Acidform 5 g
- DRUG Placebo 4 g
- DRUG Acidform 4 g
- DRUG Acidform 3 g
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 105 participants |
| Start Date | 2016-08-24 |
| Est. Completion | 2016-12-12 |
| Phase | Phase 1 |
What the finished NCT02693418 record still lists
NCT02693418 is an interventional study that assigns participants to a tested intervention. The registered 105 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% higher).
The record links to 0 conditions, and to 4 interventions - of which Acidform 5 g is the first listed.
NCT02693418 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02693418 about?
NCT02693418 is a clinical study titled "Duration of Effect of Acidform Gel on Vaginal pH". 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, ...
What is the current status of trial NCT02693418?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 105 participants. The study started on 2016-08-24. Estimated completion is 2016-12-12.
What interventions are being tested in trial NCT02693418?
The interventions under investigation include: Acidform 5 g (DRUG), Placebo 4 g (DRUG), Acidform 4 g (DRUG), Acidform 3 g (DRUG).
Who is sponsoring clinical trial NCT02693418?
This trial is sponsored by Evofem, which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02693418's enrollment target sits among peer trials
105 533rd of 2000 higher than 1,465 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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