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NCT02668796 · ClinicalTrials.gov registry record · Phase 3
To Study Generic Estradiol 10 mcg Vaginal Tablets in the Treatment of Vulvar and Vaginal Atrophy in Post Menopausal Women.
A Phase 3 study, sponsored by Glenmark Pharmaceuticals Ltd. India.
- Completed
- Registry status
- Phase 3
- Development phase
- 522
- Enrollment target
NCT02668796: Completed Phase 3 study, sponsored by Glenmark Pharmaceuticals Ltd. India.
NCT02668796 is a Phase 3 study that has completed, run by Glenmark Pharmaceuticals Ltd. India. The registered enrollment target is 522 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (32% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02668796, a Phase 3 study, has completed, sponsored by Glenmark Pharmaceuticals Ltd. India.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 522 participants
- Enrollment target
Study Summary
This is a Randomized, Parallel-Group, Placebo- Controlled, Multicenter Study to Evaluate the Therapeutic Equivalence and Safety of Estradiol Vaginal Tablets 10 mcg and Vagifem® (Estradiol Vaginal Tablets) 10 mcg (Novo Nordisk Inc.) in Female Subjects with Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy Associated with Menopause.
Interventions
- DRUG Estradiol Vaginal Tablets 10 mcg (Glenmark)
- DRUG Vagifem® (Estradiol Vaginal Tablets) 10 mcg (Novo Nordisk)
- DRUG Placebo of Estradiol Vaginal Tablets 10 mcg (Glenmark)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 522 participants |
| Start Date | 2016-01 |
| Est. Completion | 2016-09-21 |
| Phase | Phase 3 |
What the finished NCT02668796 record still lists
NCT02668796 is an interventional study that assigns participants to a tested intervention. The registered 522 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 (32% lower).
The record links to 0 conditions, and to 3 interventions - of which Estradiol Vaginal Tablets 10 mcg (Glenmark) is the first listed.
NCT02668796 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02668796 about?
NCT02668796 is a clinical study titled "To Study Generic Estradiol 10 mcg Vaginal Tablets in the Treatment of Vulvar and Vaginal Atrophy in Post Menopausal Women.". This is a Randomized, Parallel-Group, Placebo- Controlled, Multicenter Study to Evaluate the Therapeutic Equivalence and Safety of Estradiol Vaginal Tablets 10 mcg and Vagifem® (Estradiol Vaginal Tablets) 10 mcg (Novo Nordisk Inc.) in Female Subjects with Moderate to Severe Symptoms of Vulvar and Va...
What is the current status of trial NCT02668796?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 522 participants. The study started on 2016-01. Estimated completion is 2016-09-21.
What interventions are being tested in trial NCT02668796?
The interventions under investigation include: Estradiol Vaginal Tablets 10 mcg (Glenmark) (DRUG), Vagifem® (Estradiol Vaginal Tablets) 10 mcg (Novo Nordisk) (DRUG), Placebo of Estradiol Vaginal Tablets 10 mcg (Glenmark) (DRUG).
Who is sponsoring clinical trial NCT02668796?
This trial is sponsored by Glenmark Pharmaceuticals Ltd. India, which has 8 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02668796's enrollment target sits among peer trials
522 716th of 2000 higher than 1,284 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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