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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 is a Phase 3 study that has completed, run by Duramed Research. The registered enrollment target is 622 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00361569
The ClinicalTrials.gov registry entry for NCT00361569 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 622 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duramed Research, which has 23 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00361569 reports 0 study locations.
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.
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