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NCT02770365 · ClinicalTrials.gov registry record · Phase 3
Comparative Safety and Efficacy of Two Treatments in the Treatment of Vulvar and Vaginal Atrophy
A Phase 3 study of Atrophy, sponsored by Padagis.
- Completed
- Registry status
- Phase 3
- Development phase
- 695
- Enrollment target
- 1
- Study location
NCT02770365: Completed Phase 3 study of Atrophy, sponsored by Padagis.
NCT02770365 is a Phase 3 study of Atrophy that has completed, run by Padagis. The registered enrollment target is 695 participants, above the 106-participant average among 5 other Atrophy trials with a reported enrollment target (556% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02770365, a Phase 3 study of Atrophy, has completed, sponsored by Padagis.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 695 participants
- Enrollment target
- 1
- Study location
Study Summary
To compare safety and efficacy of Perrigo's drug product compared to an FDA approved drug product in the treatment of vulvar and vaginal atrophy.
Primary Outcome
A responder is a subject meeting specific vaginal cytology criteria AND a vaginal pH \< 5.0 with a change from Visit 1 of at least 0.5.
Conditions Studied
Interventions
- DRUG estrace cream (Perrigo)
- DRUG estrace cream (Reference)
- DRUG Placebo cream
Study Locations (1)
Florida
- Comprehensive Clinical Trials, LLC - West Palm Beach
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 695 participants |
| Start Date | 2016-05 |
| Est. Completion | 2016-11 |
| Phase | Phase 3 |
What the finished NCT02770365 record still lists
NCT02770365 is an interventional study that assigns participants to a tested intervention. The registered 695 participants enrollment target is mid-sized for trials with a published cap, above the 106-participant average among 5 other Atrophy trials with a reported enrollment target (556% higher).
The record links to 1 condition, with Atrophy appearing as the primary indexed condition, and to 3 interventions - of which estrace cream (Perrigo) is the first listed.
NCT02770365 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT02770365 about?
NCT02770365 is a clinical study titled "Comparative Safety and Efficacy of Two Treatments in the Treatment of Vulvar and Vaginal Atrophy". To compare safety and efficacy of Perrigo's drug product compared to an FDA approved drug product in the treatment of vulvar and vaginal atrophy.
What is the current status of trial NCT02770365?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 695 participants. The study started on 2016-05. Estimated completion is 2016-11.
What conditions does trial NCT02770365 study?
This clinical trial studies the following conditions: Atrophy.
What interventions are being tested in trial NCT02770365?
The interventions under investigation include: estrace cream (Perrigo) (DRUG), estrace cream (Reference) (DRUG), Placebo cream (DRUG).
Who is sponsoring clinical trial NCT02770365?
This trial is sponsored by Padagis, which has 17 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02770365 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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