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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.
The overall study duration will be approximately 16 weeks. After a screening/baseline period of up to 4 weeks patients will be randomized to receive either placebo tablets or Cenestin 0.3mg tablets
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cenestin 0.3 mg Tablets | Drug | 1 tablet daily |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in average frequency of moderate to severe hot flashes | Baseline to Day 28 and to Day 84 | |
| Mean change in severity of moderate to severe hot flashes | Baseline to Day 28 and to Day 84 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of Cenestin 0.3mg | Throughout study |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Duramed Research Protocol Chair | Duramed Research, Inc | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duramed Investigational Site | Huntsville | Alabama | 35801 | United States | ||
| Duramed Investigational Site |
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| Placebo | Other | 1 tablet daily |
|
|
| Montgomery |
| Alabama |
| 36116 |
| United States |
| Duramed Investigational Site | Phoenix | Arizona | 85013 | United States |
| Duramed Investigational Site | Phoenix | Arizona | 85032 | United States |
| Duramed Investigational Site | Tucson | Arizona | 85712 | United States |
| Duramed Investigational Site | Carmichael | California | 95608 | United States |
| Duramed Investigational Site | Irvine | California | 92618 | United States |
| Duramed Investigational Site | San Diego | California | 72108 | United States |
| Duramed Investigational Site | San Diego | California | 92103 | United States |
| Duramed Investigational Site | San Diego | California | 92123 | United States |
| Duramed Investigational Site | San Ramon | California | 94583 | United States |
| Duramed Investigational Site | Brooksville | Florida | 34613 | United States |
| Duramed Investigational Site | Coral Gables | Florida | 33134 | United States |
| Duramed Investigational Site | Gainesville | Florida | 32607 | United States |
| Duramed Investigational Site | Leesburg | Florida | 34748 | United States |
| Duramed Investigational Site | Miami | Florida | 33143 | United States |
| Duramed Investigational Site | Palm Springs | Florida | 33461 | United States |
| Duramed Investigational Site | Venice | Florida | 34285 | United States |
| Duramed Investigational Site | Alpharetta | Georgia | 30005 | United States |
| Duramed Investigational Site | Douglasville | Georgia | 30134 | United States |
| Duramed Investigational Site | Boise | Idaho | 83712 | United States |
| Duramed Investigational Site | Evansville | Indiana | 47714 | United States |
| Duramed Investigational Site | Lexington | Kentucky | 40509 | United States |
| Duramed Investigational Site | Baltimore | Maryland | 21224 | United States |
| Duramed Investigational Site | Lincoln | Nebraska | 68510 | United States |
| Duramed Investigational Site | Las Vegas | Nevada | 89146 | United States |
| Duramed Investigational Site | Albuquerque | New Mexico | 87102 | United States |
| Duramed Investigational Site | Cleveland | Ohio | 44122 | United States |
| Duramed Investigational Site | Columbus | Ohio | 43213 | United States |
| Duramed Investigational Site | Mayfield Heights | Ohio | 44124 | United States |
| Duramed Investigational Site | Medford | Oregon | 97504 | United States |
| Duramed Investigational Site | King of Prussia | Pennsylvania | 19406 | United States |
| Duramed Investigational Site | North Wales | Pennsylvania | 19454 | United States |
| Duramed Investigational Site | Philadelphia | Pennsylvania | 19107 | United States |
| Duramed Investigational Site | Philadelphia | Pennsylvania | 19114 | United States |
| Duramed Investigational Site | Pittsburgh | Pennsylvania | 15206 | United States |
| Duramed Investigational Site | Charleston | South Carolina | 29401 | United States |
| Duramed Investigational Site | Bristol | Tennessee | 37620 | United States |
| Duramed Investigational Site | Clarksville | Tennessee | 37043 | United States |
| Duramed Investigational Site | Nashville | Tennessee | 37203 | United States |
| Duramed Investigational Site | Dallas | Texas | 75390 | United States |
| Duramed Investigational Site | Fort Worth | Texas | 76104 | United States |
| Duramed Investigational Site | Houston | Texas | 77015 | United States |
| Duramed Investigational Site | Houston | Texas | 77030 | United States |
| Duramed Investigational Site | Houston | Texas | 77074 | United States |
| Duramed Investigational Site | San Antonio | Texas | 78229 | United States |
| Duramed Investigational Site | Norfolk | Virginia | 23507 | United States |
| Duramed Investigational Site | Spokane | Washington | 92207 | United States |
| Duramed Investigational Site | Tacoma | Washington | 98405 | United States |
| ID | Term |
|---|---|
| D019584 | Hot Flashes |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C509653 | estrogens, conjugated synthetic A |
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