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Clinical trial

An Investigator-Blind, Randomized, Parallel-Group, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Bioequivalence of Estradiol Vaginal Inserts, USP 10 mcg and Vagifem® (Estradiol Vaginal Tablets) 10 mcg and Compare Both Active Treatments to a Placebo Control in Female Subjects With Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy Associated With Menopause

NCT01779947 is registered in ClinicalTrials.gov with Amneal Pharmaceuticals, LLC as lead sponsor.

NCT NCT01779947
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Registry record

As filed in ClinicalTrials.gov.

Title
An Investigator-Blind, Randomized, Parallel-Group, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Bioequivalence of Estradiol Vaginal Inserts, USP 10 mcg and Vagifem® (Estradiol Vaginal Tablets) 10 mcg and Compare Both Active Treatments to a Placebo Control in Female Subjects With Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy Associated With Menopause
Lead sponsor
Amneal Pharmaceuticals, LLC
Phase
Phase 3
Overall status
Completed
Start date
March 31, 2012
Completion date
December 31, 2012
Enrollment
519 (actual)
Sites
25

Conditions

As the registry lists them; a condition with its own page is linked.

atrophic vaginitis due to menopause