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NCT01256684 · ClinicalTrials.gov registry record · Phase 3
DHEA Against Vaginal Atrophy - 3-Month Efficacy Study
A Phase 3 study, sponsored by EndoCeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 255
- Enrollment target
NCT01256684: Completed Phase 3 study, sponsored by EndoCeutics.
NCT01256684 is a Phase 3 study that has completed, run by EndoCeutics. The registered enrollment target is 255 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01256684, a Phase 3 study, has completed, sponsored by EndoCeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 255 participants
- Enrollment target
Study Summary
The purpose of this Phase III trial is to confirm the efficacy of intravaginal dehydroepiandrosterone (DHEA) in postmenopausal women with vaginal atrophy.
Primary Outcome
The percentage of parabasal cell was determined from the vaginal smears collected during the study. A 100-cell count was performed by a central laboratory to classify cells as parabasal (P) (including the basal), intermediate (I), and superficial (S) squamous cell types. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.
Interventions
- DRUG Placebo
- DRUG DHEA
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 255 participants |
| Start Date | 2010-12 |
| Est. Completion | 2011-11 |
| Phase | Phase 3 |
What the finished NCT01256684 record still lists
NCT01256684 is an interventional study that assigns participants to a tested intervention. The registered 255 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (67% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01256684 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01256684 about?
NCT01256684 is a clinical study titled "DHEA Against Vaginal Atrophy - 3-Month Efficacy Study". The purpose of this Phase III trial is to confirm the efficacy of intravaginal dehydroepiandrosterone (DHEA) in postmenopausal women with vaginal atrophy.
What is the current status of trial NCT01256684?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 255 participants. The study started on 2010-12. Estimated completion is 2011-11.
What interventions are being tested in trial NCT01256684?
The interventions under investigation include: Placebo (DRUG), DHEA (DRUG).
Who is sponsoring clinical trial NCT01256684?
This trial is sponsored by EndoCeutics, which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01256684's enrollment target sits among peer trials
255 1242nd of 2000 higher than 756 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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