# Study to Evaluate the Safety and Bioequivalence of Estradiol Vaginal Inserts, 10 mcg and Vagifem® 10 mcg and Compare to Placebo

> **NCT01779947** · PHASE3 · COMPLETED · sponsor: **Amneal Pharmaceuticals, LLC** · enrollment: 519 (actual)

## Conditions studied

- Atrophic Vaginitis Due to Menopause

## Interventions

- **DRUG:** Estradiol Vaginal Tablets 10 mcg
- **DRUG:** placebo

## Key facts

- **NCT ID:** NCT01779947
- **Lead sponsor:** Amneal Pharmaceuticals, LLC
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2012-03
- **Primary completion:** 2012-09
- **Final completion:** 2012-12
- **Target enrollment:** 519 (ACTUAL)
- **Last updated:** 2014-06-26


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT01779947

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT01779947, "Study to Evaluate the Safety and Bioequivalence of Estradiol Vaginal Inserts, 10 mcg and Vagifem® 10 mcg and Compare to Placebo". Retrieved via AI Analytics 2026-05-28 from https://api.ai-analytics.org/clinical/NCT01779947. Licensed CC0.

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