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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 is a Phase 3 study that has completed, run by Glenmark Pharmaceuticals Ltd. India. The registered enrollment target is 522 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02668796
The ClinicalTrials.gov registry entry for NCT02668796 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 522 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Glenmark Pharmaceuticals Ltd. India, which has 8 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Estradiol Vaginal Tablets 10 mcg (Glenmark) is the first listed.
NCT02668796 reports 0 study locations.
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.
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