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NCT00361569 · ClinicalTrials.gov registry record · Phase 3
A Clinical Trial to Evaluate the Safety and Efficacy of DR-2041(Synthetic Conjugated Estrogens, A) for Treatment of Vulvovaginal Atrophy
A Phase 3 study, sponsored by Duramed Research.
- Completed
- Registry status
- Phase 3
- Development phase
- 622
- Enrollment target
NCT00361569: Completed Phase 3 study, sponsored by Duramed Research.
NCT00361569 is a Phase 3 study that has completed, run by Duramed Research. The registered enrollment target is 622 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (19% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00361569, a Phase 3 study, has completed, sponsored by Duramed Research.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 622 participants
- Enrollment target
Study Summary
This is a four-arm, randomized, double-blind, parallel group, placebo-controlled study to compare the effects of two doses of DR-2041(Synthetic Conjugated Estrogens, A) Vaginal Cream on vulvovaginal atrophy in postmenopausal women with or without a hysterectomy and/or oophorectomy.
Primary Outcome
Change= Week 12 score - Baseline Score. The most bothersome symptom was derived from the subject self-assessment of vaginal atrophy, which consisted of 5 questions concerning severity of symptoms graded on a scale of 0-3(none, mild, moderate or severe) or 7 for not applicable.
Interventions
- OTHER Placebo
- DRUG DR-2041a
- DRUG DR-2041b
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 622 participants |
| Start Date | 2006-08 |
| Est. Completion | 2007-09 |
| Phase | Phase 3 |
What the finished NCT00361569 record still lists
NCT00361569 is an interventional study that assigns participants to a tested intervention. The registered 622 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 (19% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00361569 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00361569 about?
NCT00361569 is a clinical study titled "A Clinical Trial to Evaluate the Safety and Efficacy of DR-2041(Synthetic Conjugated Estrogens, A) for Treatment of Vulvovaginal Atrophy". This is a four-arm, randomized, double-blind, parallel group, placebo-controlled study to compare the effects of two doses of DR-2041(Synthetic Conjugated Estrogens, A) Vaginal Cream on vulvovaginal atrophy in postmenopausal women with or without a hysterectomy and/or oophorectomy.
What is the current status of trial NCT00361569?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 622 participants. The study started on 2006-08. Estimated completion is 2007-09.
What interventions are being tested in trial NCT00361569?
The interventions under investigation include: Placebo (OTHER), DR-2041a (DRUG), DR-2041b (DRUG).
Who is sponsoring clinical trial NCT00361569?
This trial is sponsored by Duramed Research, which has 23 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00361569's enrollment target sits among peer trials
622 588th of 2000 higher than 1,413 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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