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NCT00196378 · ClinicalTrials.gov registry record · Phase 3
A Clinical Trial to Evaluate the Safety and Efficacy of Enjuvia 0.3 mg for the Treatment of Vulvovaginal Atrophy
A Phase 3 study, sponsored by Duramed Research.
- Completed
- Registry status
- Phase 3
- Development phase
- 300
- Enrollment target
NCT00196378: Completed Phase 3 study, sponsored by Duramed Research.
NCT00196378 is a Phase 3 study that has completed, run by Duramed Research. The registered enrollment target is 300 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (61% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00196378, a Phase 3 study, has completed, sponsored by Duramed Research.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 300 participants
- Enrollment target
Study Summary
This is a two-arm, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy of Enjuvia 0.3 mg tablets for the treatment of moderate to severe symptoms of vulvovaginal atrophy in postmenopausal women with or without a hysterectomy and/or oophorectomy.
Interventions
- OTHER Placebo
- DRUG Synthetic Conjugated estrogens, B
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2004-11 |
| Est. Completion | 2006-02 |
| Phase | Phase 3 |
What the finished NCT00196378 record still lists
NCT00196378 is an interventional study that assigns participants to a tested intervention. The registered 300 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 (61% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00196378 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00196378 about?
NCT00196378 is a clinical study titled "A Clinical Trial to Evaluate the Safety and Efficacy of Enjuvia 0.3 mg for the Treatment of Vulvovaginal Atrophy". This is a two-arm, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy of Enjuvia 0.3 mg tablets for the treatment of moderate to severe symptoms of vulvovaginal atrophy in postmenopausal women with or without a hysterectomy and/or oophorectomy.
What is the current status of trial NCT00196378?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 300 participants. The study started on 2004-11. Estimated completion is 2006-02.
What interventions are being tested in trial NCT00196378?
The interventions under investigation include: Placebo (OTHER), Synthetic Conjugated estrogens, B (DRUG).
Who is sponsoring clinical trial NCT00196378?
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 NCT00196378's enrollment target sits among peer trials
300 1122nd of 2000 higher than 840 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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