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Completed Phase 3 Interventional

A Clinical Trial to Evaluate the Safety and Efficacy of Enjuvia 0.3 mg for the Treatment of Vulvovaginal Atrophy

ClinicalTrials.gov ID: NCT00196378

Public ClinicalTrials.gov record NCT00196378. 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.

ClinicalTrials.gov public records Last synced Oct 20, 2026, 6:12 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Randomized, Multicenter, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Synthetic Conjugated Estrogens, B (Enjuvia) 0.3 mg Tablets for the Treatment of Vulvovaginal Atrophy in Healthy Postmenopausal Women

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This is a two-arm, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy of Enjuvia 0.3 mg tablets for the treatment of moderate to severe symptoms of vulvovaginal atrophy in postmenopausal women with or without a hysterectomy and/or oophorectomy.

Study identification

NCT ID
NCT00196378
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Duramed Research
Industry
Enrollment
300 participants

Conditions and interventions

Conditions

Interventions

Drug · Other

Eligibility (public fields only)

Age range
30 Years to 80 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
Nov 2004 (Type not available)
Primary completion
Feb 2006 (Actual)
Completion
Feb 2006 (Actual)
Last update posted
Sep 2, 2013

2004 – 2006

United States locations

U.S. sites
38
U.S. states
22
U.S. cities
34
Facility City State ZIP Site status
Duramed Investigational Site Huntsville Alabama 35801 —
Duramed Investigational Site Tucson Arizona 85712 —
Duramed Investigational Site Carmichael California 95608 —
Duramed Investigational Site San Diego California 92103 —
Duramed Investigational Site San Diego California 92108 —
Duramed Investigational Site Colorado Springs Colorado 80909 —
Duramed Investigational Site Denver Colorado 80202 —
Duramed Investigational Site Gainesville Florida 32607 —
Duramed Investigational Site Miami Florida 33143 —
Duramed Investigational Site Miami Florida 33186 —
Duramed Investigational Site Sarasota Florida 34239 —
Duramed Investigational Site Venice Florida 34285 —
Duramed Investigational Site Alpharetta Georgia 30005 —
Duramed Investigational Site Boise Idaho 83712 —
Duramed Investigational Site Evansville Indiana 47714 —
Duramed Investigational Site Baton Rouge Louisiana 70808 —
Duramed Investigational Site Laurel Maryland 20707 —
Duramed Investigational Site Billings Montana 59101 —
Duramed Investigational Site Las Vegas Nevada 89109 —
Duramed Investigational Site Las Vegas Nevada 89128 —
Duramed Investigational Site Las Vegas Nevada 89146 —
Duramed Investigational Site Winston-Salem North Carolina 27103 —
Duramed Investigational Site Cleveland Ohio 44122 —
Duramed Investigational Site Columbus Ohio 43213 —
Duramed Investigational Site Mayfield Heights Ohio 44124 —
Duramed Investigational Site Oklahoma City Oklahoma 73112 —
Duramed Investigational Site Medford Oregon 97504 —
Duramed Investigational Site Pittsburgh Pennsylvania 15206 —
Duramed Investigational Site Columbia South Carolina 29201 —
Duramed Investigational Site Clarksville Tennessee 37043 —
Duramed Investigational Site Memphis Tennessee 38120 —
Duramed Investigational Site Fort Worth Texas 76104 —
Duramed Investigational Site San Antonio Texas 78229 —
Duramed Investigational Site Sugarland Texas 77478 —
Duramed Investigational Site Newport News Virginia 23602 —
Duramed Investigational Site Norfolk Virginia 23507 —
Duramed Investigational Site Spokane Washington 99207 —
Duramed Investigational Site Tacoma Washington 98405 —

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 NCT00196378, 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 Sep 2, 2013 · Synced Oct 20, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00196378 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →