Study to Evaluate the Safety and Bioequivalence of Estradiol Vaginal Inserts, 10 mcg and Vagifem® 10 mcg and Compare to Placebo
Public ClinicalTrials.gov record NCT01779947. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official 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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to compare the safety and efficacy of generic Estradiol Vaginal Inserts, USP 10 mcg to the reference product Vagifem® 10 mcg and to determined whether the efficacy of each of the 2 active treatments is superior to that of the placebo.
Study identification
- NCT ID
- NCT01779947
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 519 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 30 Years to 75 Years
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 2012 (Type not available)
- Primary completion
- Sep 2012 (Actual)
- Completion
- Dec 2012 (Actual)
- Last update posted
- Jun 26, 2014
2012
United States locations
- U.S. sites
- 25
- U.S. states
- 13
- U.S. cities
- 22
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Medical Affiliated Research center, Inc. | Huntsville | Alabama | 35801 | — |
| Montogmery Women's Health Associates | Montgomery | Alabama | 36117 | — |
| Medical Center for Clinical Research | San Diego | California | 92108 | — |
| Women's Health Care Research Corp. | San Diego | California | 92123 | — |
| Downtown Women's Health care | Denver | Colorado | 80218 | — |
| Horizons Clinical Research Center | Denver | Colorado | 80220 | — |
| James A. Simon, MD PC/ Women's Health and Research Consultants | Washington D.C. | District of Columbia | 20036 | — |
| Visions Clinical Reserach | Boynton Beach | Florida | 33472 | — |
| Jacksonville Center for Clinical Research | Jacksonville | Florida | 32216 | — |
| Altus Research | Lake Worth | Florida | 33461 | — |
| New Age Medical Reserach Group | Miami | Florida | 33186 | — |
| Comprehensive Clinical Trials, LLC | West Palm Beach | Florida | 33409 | — |
| Atlanta North Gynecology | Roswell | Georgia | 30075 | — |
| Mount Vernon Clinical Research, LLC | Sandy Springs | Georgia | 30328 | — |
| Cypress Medical Research Center. LLC | Wichita | Kansas | 67226 | — |
| Meridian Health Care | Neptune City | New Jersey | 07753 | — |
| Center for Women's Health and Wellness, LLC/ Women's Health Research Center | Plainsboro | New Jersey | 08536 | — |
| Premier Medical Group of the Hudson Valley | Poughkeepsie | New York | 12601 | — |
| Lyndhurst Clinical Research | Raleigh | North Carolina | 27607 | — |
| Wake Research Associates | Raleigh | North Carolina | 27612 | — |
| Hawthorne Medical Research, Inc. | Winstom-Salem | North Carolina | 27103 | — |
| Lyndhurst Clinical Research | Winston-Salem | North Carolina | 27103 | — |
| Columbus Center for Women;s Health Reserach | Columbus | Ohio | 43213 | — |
| Clinical Research of Philadelphia, LLC | Philadelphia | Pennsylvania | 19114 | — |
| Seatlle Womne's Health,Reserach, Gynecology | Seattle | Washington | 98105 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01779947, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 26, 2014 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01779947 live on ClinicalTrials.gov.