Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 3 study, sponsored by EndoCeutics.
NCT02013544 is a Phase 3 study that has completed, run by EndoCeutics. The registered enrollment target is 558 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (28% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The percentage of superficial cells 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 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 Prasterone (DHEA)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 558 participants |
| Start Date | 2014-02 |
| Est. Completion | 2015-02 |
| Phase | Phase 3 |
What the finished NCT02013544 record still lists
NCT02013544 is an interventional study that assigns participants to a tested intervention. The registered 558 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 (28% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02013544 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02013544's enrollment target sits among peer trials
558 673rd of 2000 higher than 1,327 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT07173751 · 558 participants · Phase 3
ROSETTA Breast-01: The Effects and Safety of Pumitamig in Patients With Triple-Negative Breast Cancer
- NCT05708885 · 557 participants · NA
Striated Esophageal Motor Function Modulation in Health and Disease
- NCT04661358 · 560 participants · Phase 3
Fenofibrate for Prevention of DR Worsening
- NCT05473871 · 560 participants · NA
Enhancing Capacity in Churches to Implement PA Programs
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia