Menopause Clinical Trial
Official title:
A Randomized, Multicenter, Double-Blind, Placebo-Controlled Trial to Compare the Effects of 12 Weeks of Treatment With DR-2041(Synthetic Conjugated Estrogens, A) Vaginal Cream vs. Placebo Vaginal Cream on Vulvovaginal Atrophy in Healthy Postmenopausal Women
| Verified date | March 2015 |
| Source | Teva Pharmaceutical Industries |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
This is a four-arm, randomized, double-blind, parallel group, placebo-controlled study to compare the effects of two doses of DR-2041(Synthetic Conjugated Estrogens, A) Vaginal Cream on vulvovaginal atrophy in postmenopausal women with or without a hysterectomy and/or oophorectomy.
| Status | Completed |
| Enrollment | 622 |
| Est. completion date | September 2007 |
| Est. primary completion date | September 2007 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 30 Years to 80 Years |
| Eligibility |
Inclusion Criteria: - Naturally or surgically menopausal - Moderate or severe symptoms of vaginal atrophy (ie, dryness, itching, pain, uncomfortable intercourse) Exclusion Criteria: - Known sensitivity or contraindication to estrogens or progestins - History or current diagnosis endometrial hyperplasia - Recent history of vaginal bleeding of unknown cause - Recent history or diagnosis of endometriosis - Any contraindication to estrogen therapy |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Duramed Investigational Site | Albuquerque | New Mexico |
| United States | Duramed Investigational Site | Allentown | Pennsylvania |
| United States | Duramed Investigational Site | Alpharetta | Georgia |
| United States | Duramed Investigational Site | Atlanta | Georgia |
| United States | Duramed Investigational Site | Augusta | Georgia |
| United States | Duramed Investigational Site | Austin | Texas |
| United States | Duramed Investigational Site | Austin | Texas |
| United States | Duramed Investigational Site | Baltimore | Maryland |
| United States | Duramed Investigational Site | Carmichael | California |
| United States | Duramed Investigational Site | Charleston | South Carolina |
| United States | Duramed Investigational Site | Charleston | South Carolina |
| United States | Duramed Investigational Site | Chicago | Illinois |
| United States | Duramed Investigational Site | Chicago | Illinois |
| United States | Duramed Investigational Site | Cincinnati | Ohio |
| United States | Duramed Investigational Site | Clearwater | Florida |
| United States | Duramed Investigational Site | Clearwater | Florida |
| United States | Duramed Investigational Site | Cleveland | Ohio |
| United States | Duramed Investigational Site | Colorado Springs | Colorado |
| United States | Duramed Investigational Site | Columbia | South Carolina |
| United States | Duramed Investigational Site | Columbus | Ohio |
| United States | Duramed Investigational Site | Columbus | Ohio |
| United States | Duramed Investigational Site | Columbus | Ohio |
| United States | Duramed Investigational Site | Corpus Christi | Texas |
| United States | Duramed Investigational Site | Dallas | Texas |
| United States | Duramed Investigational Site | Decatur | Georgia |
| United States | Duramed Investigational Site | Douglasville | Georgia |
| United States | Duramed Investigational Site | Evansville | Indiana |
| United States | Duramed Investigational Site | Fresno | California |
| United States | Duramed Investigational Site | Gainesville | Florida |
| United States | Duramed Investigational Site | Houston | Texas |
| United States | Duramed Investigational Site | Houston | Texas |
| United States | Duramed Investigational Site | Houston | Texas |
| United States | Duramed Investigational Site | Houston | Texas |
| United States | Duramed Investigational Site | Huntsville | Alabama |
| United States | Duramed Investigational Site | Jacksonville | Florida |
| United States | Duramed Investigational Site | Jamestown | North Dakota |
| United States | Duramed Investigational Site | Johnson City | New York |
| United States | Duramed Investigational Site | King of Prussia | Pennsylvania |
| United States | Duramed Investigational Site | Las Vegas | Nevada |
| United States | Duramed Investigational Site | Lawrenceville | New Jersey |
| United States | Duramed Investigational Site | Lebanon | New Hampshire |
| United States | Duramed Investigational Site | Leesburg | Florida |
| United States | Duramed Investigational Site | Lexington | Kentucky |
| United States | Duramed Investigational Site | Lincoln | Nebraska |
| United States | Duramed Investigational Site | Livonia | Michigan |
| United States | Duramed Investigational Site | Louisville | Kentucky |
| United States | Duramed Investigational Site | Madisonville | Kentucky |
| United States | Duramed Investigational Site | Mayfield Heights | Ohio |
| United States | Duramed Investigational Site | Medford | Oregon |
| United States | Duramed Investigational Site | Media | Pennsylvania |
| United States | Duramed Investigational Site | Memphis | Tennessee |
| United States | Duramed Investigational Site | Miami | Florida |
| United States | Duramed Investigational Site | Minot | North Dakota |
| United States | Duramed Investigational Site | Mobile | Alabama |
| United States | Duramed Investigational Site | Montgomery | Alabama |
| United States | Duramed Investigational Site | Moorestown | New Jersey |
| United States | Duramed Investigational Site | Nashville | Tennessee |
| United States | Duramed Investigational Site | New Brunswick | New Jersey |
| United States | Duramed Investigational Site | New London | Connecticut |
| United States | Duramed Investigational Site | Newport News | Virginia |
| United States | Duramed Investigational Site | Overland Park | Kansas |
| United States | Duramed Investigational Site | Philadelphia | Pennsylvania |
| United States | Duramed Investigational Site | Philadelphia | Pennsylvania |
| United States | Duramed Investigational Site | Phoenix | Arizona |
| United States | Duramed Investigational Site | Phoenix | Arizona |
| United States | Duramed Investigational Site | Phoenix | Arizona |
| United States | Duramed Investigational Site | Pinellas Park | Florida |
| United States | Duramed Investigational Site | Pittsburgh | Pennsylvania |
| United States | Duramed Investigational Site | Portland | Oregon |
| United States | Duramed Investigational Site | Portland | Oregon |
| United States | Duramed Investigational Site | Pueblo | Colorado |
| United States | Duramed Investigational Site | Raleigh | North Carolina |
| United States | Duramed Investigational Site | Rosemont | Pennsylvania |
| United States | Duramed Investigational Site | San Antonio | Texas |
| United States | Duramed Investigational Site | San Diego | California |
| United States | Duramed Investigational Site | San Diego | California |
| United States | Duramed Investigational Site | San Diego | California |
| United States | Duramed Investigational Site | San Ramon | California |
| United States | Duramed Investigational Site | Sandy Springs | Georgia |
| United States | Duramed Investigational Site | Shreveport | Louisiana |
| United States | Duramed Investigational Site | Spokane | Washington |
| United States | Duramed Investigational Site | Strafford | Pennsylvania |
| United States | Duramed Investigational Site | Stuart | Florida |
| United States | Duramed Investigational Site | Tacoma | Washington |
| United States | Duramed Investigational Site | Tampa | Florida |
| United States | Duramed Investigational Site | Tampa | Florida |
| United States | Duramed Investigational Site | Tucson | Arizona |
| United States | Duramed Investigational Site | Venice | Florida |
| United States | Duramed Investigational Site | Waco | Texas |
| United States | Duramed Investigational Site | Warwick | Rhode Island |
| United States | Duramed Investigational Site | Watertown | South Dakota |
| United States | Duramed Investigational Site | West Palm Beach | Florida |
| United States | Duramed Investigational Site | West Palm Beach | Florida |
| United States | Duramed Investigational Site | Weston | Florida |
| United States | Duramed Investigational Site | Williamsville | New York |
| United States | Duramed Investigational Site | Williston | Vermont |
| United States | Duramed Investigational Site | Winston-Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Duramed Research |
United States,
Freedman M, Kaunitz AM, Reape KZ, Hait H, Shu H. Twice-weekly synthetic conjugated estrogens vaginal cream for the treatment of vaginal atrophy. Menopause. 2009 Jul-Aug;16(4):735-41. doi: 10.1097/gme.0b013e318199e734. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Mean Change in the Symptom Identified by the Patient to be Most Bothersome | Change= Week 12 score - Baseline Score. The most bothersome symptom was derived from the subject self-assessment of vaginal atrophy, which consisted of 5 questions concerning severity of symptoms graded on a scale of 0-3(none, mild, moderate or severe) or 7 for not applicable. | Baseline to Week 12 | No |
| Primary | Mean Change in Vaginal pH | Change= Week 12 vaginal pH - Baseline vaginal pH | Baseline to Week 12 | No |
| Primary | Mean Change in Maturation Index | Change= Week 12 maturation index -baseline maturation index. Matuation index was calculated using the following equation: Maturation Index = (% Parabasal cells * 0) + (% Intermediate Cells * 0.5) + (% Superficial Cells * 1.0) | Baseline to Week 12 | No |
| Secondary | Safety and Tolerability of DR-2041 (Synthetic Conjugated Estrogens, A) | Any adverse event reported from the beginning of the 28-day screening through the subject's last report. | Up to Week 12 | Yes |
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