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NCT02013544 · ClinicalTrials.gov registry record · Phase 3
Intravaginal Prasterone (DHEA) Against Vulvovaginal Atrophy Associated With Menopause
A Phase 3 study, sponsored by EndoCeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 558
- Enrollment target
NCT02013544 is a Phase 3 study that has completed, run by EndoCeutics. The registered enrollment target is 558 participants.
The verdict
NCT02013544, a Phase 3 study, has completed, sponsored by EndoCeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 558 participants
- Enrollment target
Study Summary
The purpose of this study is to confirm the efficacy of intravaginal prasterone (DHEA) on symptoms of vulvovaginal atrophy due to menopause and to collect further data on subjects exposed to intravaginal DHEA in order to meet the ICH E1 guideline requirements.
Interventions
- DRUG Placebo
- DRUG Prasterone (DHEA)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 558 participants |
| Start Date | 2014-02 |
| Est. Completion | 2015-02 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02013544
The ClinicalTrials.gov registry entry for NCT02013544 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 558 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is EndoCeutics, which has 6 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02013544 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02013544 about?
NCT02013544 is a clinical study titled "Intravaginal Prasterone (DHEA) Against Vulvovaginal Atrophy Associated With Menopause". The purpose of this study is to confirm the efficacy of intravaginal prasterone (DHEA) on symptoms of vulvovaginal atrophy due to menopause and to collect further data on subjects exposed to intravaginal DHEA in order to meet the ICH E1 guideline requirements.
What is the current status of trial NCT02013544?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 558 participants. The study started on 2014-02. Estimated completion is 2015-02.
What interventions are being tested in trial NCT02013544?
The interventions under investigation include: Placebo (DRUG), Prasterone (DHEA) (DRUG).
Who is sponsoring clinical trial NCT02013544?
This trial is sponsored by EndoCeutics, which has 6 total clinical trials registered on ClinicalTrials.gov.
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