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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 is a Phase 1 study that has completed, run by Evofem. The registered enrollment target is 105 participants.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02693418
The ClinicalTrials.gov registry entry for NCT02693418 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 105 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Evofem, which has 6 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Acidform 5 g is the first listed.
NCT02693418 reports 0 study locations.
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.
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