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NCT02195986 · ClinicalTrials.gov registry record · Phase 3
A Comparison of Estradiol Vaginal Cream to Estrace® Cream in 350 Postmenopausal Females With Atrophic Vaginitis
A Phase 3 study, sponsored by Mylan Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 366
- Enrollment target
NCT02195986: Completed Phase 3 study, sponsored by Mylan Pharmaceuticals.
NCT02195986 is a Phase 3 study that has completed, run by Mylan Pharmaceuticals. The registered enrollment target is 366 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02195986, a Phase 3 study, has completed, sponsored by Mylan Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 366 participants
- Enrollment target
Study Summary
The purpose of this study is to determine the therapeutic equivalence of Mylan's estradiol vaginal cream to Estrace® cream and superiority of both products to placebo. The protocol describes a randomized, double-blind, multi-dose, placebo-controlled, parallel study of a 7 day treatment.
Primary Outcome
Treatment comparison of the proportion of patients in the Per Protocol (PP) population who received either Estradiol Vaginal Cream or Estrace® that were identified as responders at the end of the treatment period on Study Day 8. A responder was defined as a patient with at least a 25% reduction from baseline in the sum of % basal/parabasal + % intermediate cells on vaginal cytology AND vaginal pH ≤ 5.0 with a change from baseline vaginal pH of at least 0.5.
Interventions
- DRUG Estradiol Vaginal Cream, 0.01%
- DRUG Estrace® 0.01% cream
- DRUG Placebo Vaginal Cream
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 366 participants |
| Start Date | 2014-06 |
| Est. Completion | 2014-12 |
| Phase | Phase 3 |
What the finished NCT02195986 record still lists
NCT02195986 is an interventional study that assigns participants to a tested intervention. The registered 366 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 (53% lower).
The record links to 0 conditions, and to 3 interventions - of which Estradiol Vaginal Cream, 0.01% is the first listed.
NCT02195986 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02195986 about?
NCT02195986 is a clinical study titled "A Comparison of Estradiol Vaginal Cream to Estrace® Cream in 350 Postmenopausal Females With Atrophic Vaginitis". The purpose of this study is to determine the therapeutic equivalence of Mylan's estradiol vaginal cream to Estrace® cream and superiority of both products to placebo. The protocol describes a randomized, double-blind, multi-dose, placebo-controlled, parallel study of a 7 day treatment.
What is the current status of trial NCT02195986?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 366 participants. The study started on 2014-06. Estimated completion is 2014-12.
What interventions are being tested in trial NCT02195986?
The interventions under investigation include: Estradiol Vaginal Cream, 0.01% (DRUG), Estrace® 0.01% cream (DRUG), Placebo Vaginal Cream (DRUG).
Who is sponsoring clinical trial NCT02195986?
This trial is sponsored by Mylan Pharmaceuticals, which has 146 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02195986's enrollment target sits among peer trials
366 999th of 2000 higher than 1,000 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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