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NCT01846442 · ClinicalTrials.gov registry record · Phase 3
Topical DHEA Against Vaginal Atrophy
A Phase 3 study of Vaginal Atrophy, sponsored by EndoCeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 218
- Enrollment target
- 8
- Study locations
NCT01846442: Completed Phase 3 study of Vaginal Atrophy, sponsored by EndoCeutics.
NCT01846442 is a Phase 3 study of Vaginal Atrophy that has completed, run by EndoCeutics. The registered enrollment target is 218 participants, below the 332-participant average among 9 other Vaginal Atrophy trials with a reported enrollment target (34% lower). The trial reports 8 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01846442, a Phase 3 study of Vaginal Atrophy, has completed, sponsored by EndoCeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 218 participants
- Enrollment target
- 8
- Study locations
Study Summary
The purpose of this study is to determine the dose-response of vaginal mucosa parameters to the local action of DHEA (Dehydroepiandrosterone) in postmenopausal women suffering from vaginal atrophy.
Primary Outcome
The percentage of parabasal 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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG DHEA (0.25%)
- DRUG DHEA (0.5%)
- DRUG DHEA (1.0%)
Study Locations (8)
Quebec
- EndoCeutics site # 10 - Montreal
- EndoCeutics site # 09 - Montreal
- EndoCeutics site # 08 - Shawinigan
- EndoCeutics site # 11 - Sherbrooke
Other
- EndoCeutics site # 02 - Québec
- EndoCeutics site # 01 - Québec
Ohio
- EndoCeutics site # 05 - Cleveland
Virginia
- EndoCeutics site # 03 - Norfolk
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 218 participants |
| Start Date | 2007-06 |
| Est. Completion | 2008-10 |
| Phase | Phase 3 |
What the finished NCT01846442 record still lists
NCT01846442 is an interventional study that assigns participants to a tested intervention. The registered 218 participants enrollment target is mid-sized for trials with a published cap, below the 332-participant average among 9 other Vaginal Atrophy trials with a reported enrollment target (34% lower).
The record links to 1 condition, with Vaginal Atrophy appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.
NCT01846442 lists 8 locations in 4 states (Quebec, Other, Ohio).
Frequently Asked Questions
What is clinical trial NCT01846442 about?
NCT01846442 is a clinical study titled "Topical DHEA Against Vaginal Atrophy". The purpose of this study is to determine the dose-response of vaginal mucosa parameters to the local action of DHEA (Dehydroepiandrosterone) in postmenopausal women suffering from vaginal atrophy.
What is the current status of trial NCT01846442?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 218 participants. The study started on 2007-06. Estimated completion is 2008-10.
What conditions does trial NCT01846442 study?
This clinical trial studies the following conditions: Vaginal Atrophy.
What interventions are being tested in trial NCT01846442?
The interventions under investigation include: Placebo (DRUG), DHEA (0.25%) (DRUG), DHEA (0.5%) (DRUG), DHEA (1.0%) (DRUG).
Who is sponsoring clinical trial NCT01846442?
This trial is sponsored by EndoCeutics, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01846442 being conducted?
This trial has 8 study locations across Ohio, Virginia, Quebec. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Vaginal Atrophy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01846442's enrollment target sits among peer trials
218 3rd of 9 higher than 7 of 9 other Vaginal Atrophy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Vaginal Atrophy 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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