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NCT01779947 · ClinicalTrials.gov registry record · Phase 3
Study to Evaluate the Safety and Bioequivalence of Estradiol Vaginal Inserts, 10 mcg and Vagifem® 10 mcg and Compare to Placebo
A Phase 3 study, sponsored by Amneal Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 519
- Enrollment target
NCT01779947 is a Phase 3 study that has completed, run by Amneal Pharmaceuticals. The registered enrollment target is 519 participants.
The verdict
NCT01779947, a Phase 3 study, has completed, sponsored by Amneal Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 519 participants
- Enrollment target
Study Summary
The purpose of this study is to compare the safety and efficacy of generic Estradiol Vaginal Inserts, USP 10 mcg to the reference product Vagifem® 10 mcg and to determined whether the efficacy of each of the 2 active treatments is superior to that of the placebo.
Interventions
- DRUG placebo
- DRUG Estradiol Vaginal Tablets 10 mcg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 519 participants |
| Start Date | 2012-03 |
| Est. Completion | 2012-12 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01779947
The ClinicalTrials.gov registry entry for NCT01779947 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 519 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Amneal Pharmaceuticals, which has 8 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT01779947 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01779947 about?
NCT01779947 is a clinical study titled "Study to Evaluate the Safety and Bioequivalence of Estradiol Vaginal Inserts, 10 mcg and Vagifem® 10 mcg and Compare to Placebo". The purpose of this study is to compare the safety and efficacy of generic Estradiol Vaginal Inserts, USP 10 mcg to the reference product Vagifem® 10 mcg and to determined whether the efficacy of each of the 2 active treatments is superior to that of the placebo.
What is the current status of trial NCT01779947?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 519 participants. The study started on 2012-03. Estimated completion is 2012-12.
What interventions are being tested in trial NCT01779947?
The interventions under investigation include: placebo (DRUG), Estradiol Vaginal Tablets 10 mcg (DRUG).
Who is sponsoring clinical trial NCT01779947?
This trial is sponsored by Amneal Pharmaceuticals, which has 8 total clinical trials registered on ClinicalTrials.gov.
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