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NCT01256671 · ClinicalTrials.gov registry record · Phase 3
DHEA Against Vaginal Atrophy - Safety Study of 12 Months
A Phase 3 study, sponsored by EndoCeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 530
- Enrollment target
NCT01256671: Completed Phase 3 study, sponsored by EndoCeutics.
NCT01256671 is a Phase 3 study that has completed, run by EndoCeutics. The registered enrollment target is 530 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (31% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01256671, a Phase 3 study, has completed, sponsored by EndoCeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 530 participants
- Enrollment target
Study Summary
The purpose of this Phase III trial is to assess the long-term safety of intravaginal dehydroepiandrosterone (DHEA) in non-hysterectomized postmenopausal women with vaginal atrophy aged 40 to 75 years.
Primary Outcome
The long-term safety of intravaginal prasterone has been evaluated on different parameters including the endometrium. For this purpose, endometrial biopsies were performed at screening and at the end of the study (52 weeks) or at discontinuation visit for women who were exposed to intravaginal DHEA (prasterone) for at least 12 weeks. At screening, the endometrium had to be atrophic/inactive for women to be enrolled in the study. Only the end-of-study data are presented.
Interventions
- DRUG DHEA
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 530 participants |
| Start Date | 2010-12 |
| Est. Completion | 2012-12 |
| Phase | Phase 3 |
What the finished NCT01256671 record still lists
NCT01256671 is an interventional study that assigns participants to a tested intervention. The registered 530 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 (31% lower).
The record links to 0 conditions, and to 1 intervention - of which DHEA is the first listed.
NCT01256671 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01256671 about?
NCT01256671 is a clinical study titled "DHEA Against Vaginal Atrophy - Safety Study of 12 Months". The purpose of this Phase III trial is to assess the long-term safety of intravaginal dehydroepiandrosterone (DHEA) in non-hysterectomized postmenopausal women with vaginal atrophy aged 40 to 75 years.
What is the current status of trial NCT01256671?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 530 participants. The study started on 2010-12. Estimated completion is 2012-12.
What interventions are being tested in trial NCT01256671?
The interventions under investigation include: DHEA (DRUG).
Who is sponsoring clinical trial NCT01256671?
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 NCT01256671's enrollment target sits among peer trials
530 706th of 2000 higher than 1,292 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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