Hot Flashes Clinical Trial
Official title:
A Randomized, Multicenter, Double-blind, Placebo-controlled Trial to Demonstrate the Safety and Efficacy of Daily 0.3 mg Synthetic Conjugated Estrogens, A (Cenestin) for the Treatment of Vasomotor Symptoms in Postmenopausal Women
| Verified date | July 2009 |
| 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 randomized, double-blind study to compare the efficacy and safety of daily doses of Cenestin 0.3 mg tablets to placebo in reducing the frequency and severity of moderate to severe hot flashes in postmenopausal women.
| Status | Completed |
| Enrollment | 400 |
| Est. completion date | May 2007 |
| Est. primary completion date | May 2007 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 30 Years to 80 Years |
| Eligibility |
Inclusion Criteria: - Naturally or surgically postmenopausal - At least 12 months since last menses or 6 weeks past surgery - Minimum of 7 daily or 50 weekly moderate to severe hot flashes Exclusion Criteria: - Any contraindication to natural or synthetic estrogens |
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 | Alpharetta | Georgia |
| United States | Duramed Investigational Site | Baltimore | Maryland |
| United States | Duramed Investigational Site | Boise | Idaho |
| United States | Duramed Investigational Site | Bristol | Tennessee |
| United States | Duramed Investigational Site | Brooksville | Florida |
| United States | Duramed Investigational Site | Carmichael | California |
| United States | Duramed Investigational Site | Charleston | South Carolina |
| United States | Duramed Investigational Site | Clarksville | Tennessee |
| United States | Duramed Investigational Site | Cleveland | Ohio |
| United States | Duramed Investigational Site | Columbus | Ohio |
| United States | Duramed Investigational Site | Coral Gables | Florida |
| United States | Duramed Investigational Site | Dallas | Texas |
| United States | Duramed Investigational Site | Douglasville | Georgia |
| United States | Duramed Investigational Site | Evansville | Indiana |
| United States | Duramed Investigational Site | Fort Worth | Texas |
| 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 | Huntsville | Alabama |
| United States | Duramed Investigational Site | Irvine | California |
| United States | Duramed Investigational Site | King of Prussia | Pennsylvania |
| United States | Duramed Investigational Site | Las Vegas | Nevada |
| 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 | Mayfield Heights | Ohio |
| United States | Duramed Investigational Site | Medford | Oregon |
| United States | Duramed Investigational Site | Miami | Florida |
| United States | Duramed Investigational Site | Montgomery | Alabama |
| United States | Duramed Investigational Site | Nashville | Tennessee |
| United States | Duramed Investigational Site | Norfolk | Virginia |
| United States | Duramed Investigational Site | North Wales | Pennsylvania |
| United States | Duramed Investigational Site | Palm Springs | Florida |
| 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 | Pittsburgh | 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 | Spokane | Washington |
| United States | Duramed Investigational Site | Tacoma | Washington |
| United States | Duramed Investigational Site | Tucson | Arizona |
| United States | Duramed Investigational Site | Venice | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| Duramed Research |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Mean change in average frequency of moderate to severe hot flashes | Baseline to Day 28 and to Day 84 | No | |
| Primary | Mean change in severity of moderate to severe hot flashes | Baseline to Day 28 and to Day 84 | No | |
| Secondary | Safety and tolerability of Cenestin 0.3mg | Throughout study | Yes |
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