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Clinical trial

A Phase III Investigator-Blind, Randomized, Parallel-Group, Placebo- Controlled, Multicentre Study to Evaluate the Therapeutic Equivalence and Safety of Estradiol Vaginal Tablets 10 mcg and Vagifem® (Estradiol Vaginal Tablets) 10 mcg (Novo Nordisk Inc.) Administered for 14 Days 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.

NCT02668796 is registered in ClinicalTrials.gov with Glenmark Pharmaceuticals Ltd. India as lead sponsor.

NCT NCT02668796
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Registry record

As filed in ClinicalTrials.gov.

Title
A Phase III Investigator-Blind, Randomized, Parallel-Group, Placebo- Controlled, Multicentre Study to Evaluate the Therapeutic Equivalence and Safety of Estradiol Vaginal Tablets 10 mcg and Vagifem® (Estradiol Vaginal Tablets) 10 mcg (Novo Nordisk Inc.) Administered for 14 Days 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
Glenmark Pharmaceuticals Ltd. India
Phase
Phase 3
Overall status
Completed
Start date
January 31, 2016
Completion date
September 21, 2016
Enrollment
522 (actual)
Sites
1

Conditions

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

vulvar and vaginal atrophy