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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: Completed Phase 3 study, sponsored by Amneal Pharmaceuticals.
NCT01779947 is a Phase 3 study that has completed, run by Amneal Pharmaceuticals. The registered enrollment target is 519 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (33% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
A responder was defined as a subject with at least a 25% reduction from baseline in the sum of % basal/parabasal and % intermediate cells on vaginal cytology AND vaginal pH \< 5.0 with a change from baseline vaginal pH of at least 0.5, where baseline values were collected at Visit 1
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 |
What the finished NCT01779947 record still lists
NCT01779947 is an interventional study that assigns participants to a tested intervention. The registered 519 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 (33% lower).
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT01779947 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01779947's enrollment target sits among peer trials
519 723rd of 2000 higher than 1,278 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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