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The purpose of this study is to determine whether Bazedoxifine/conjugated estrogens are effective in the treatment of vaginal atrophy.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bazedoxifene/Conjugated Estrogen | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Superficial cells (by cervical/vaginal cytologic smear) at screening, and weeks 4 and 12. | ||
| Parabasal cells (by cervical/vaginal cytologic smear) at screening, and weeks 4 and 12. |
| Measure | Description | Time Frame |
|---|---|---|
| Vaginal pH at screening, and weeks 4 and 12. | ||
| Most bothersome moderate or severe vulvar/vaginal atrophy sympton at screening, and weeks 4 and 12. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Wyeth is now a wholly owned subsidiary of Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37619252 | Derived | Lara LA, Cartagena-Ramos D, Figueiredo JB, Rosa-E-Silva ACJ, Ferriani RA, Martins WP, Fuentealba-Torres M. Hormone therapy for sexual function in perimenopausal and postmenopausal women. Cochrane Database Syst Rev. 2023 Aug 24;8(8):CD009672. doi: 10.1002/14651858.CD009672.pub3. | |
| 28539177 | Derived | Pinkerton JV, Bushmakin AG, Komm BS, Abraham L. Relationship between changes in vulvar-vaginal atrophy and changes in sexual functioning. Maturitas. 2017 Jun;100:57-63. doi: 10.1016/j.maturitas.2017.03.315. Epub 2017 Mar 22. |
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| Montgomery |
| Alabama |
| United States |
| Scottsdale | Arizona | United States |
| Tucson | Arizona | United States |
| Oakland | California | United States |
| San Diego | California | United States |
| Upland | California | 91786 | United States |
| Denver | Colorado | 80202 | United States |
| Avon | Connecticut | United States |
| Groton | Connecticut | United States |
| Waterbury | Connecticut | United States |
| Aventura | Florida | 33180 | United States |
| Gainesville | Florida | United States |
| Miami | Florida | United States |
| Palm Harbor | Florida | United States |
| Palm Springs | Florida | United States |
| Pinnellas Park | Florida | United States |
| Stuart | Florida | United States |
| Tampa | Florida | United States |
| West Palm Beach | Florida | United States |
| Atlanta | Georgia | 30328 | United States |
| Conyers | Georgia | United States |
| Douglasville | Georgia | United States |
| Savannah | Georgia | United States |
| Idaho Falls | Idaho | United States |
| Champaign | Illinois | United States |
| Chicago | Illinois | United States |
| Kansas City | Kansas | United States |
| Shreveport | Louisiana | United States |
| Baltimore | Maryland | United States |
| Ann Arbor | Michigan | United States |
| Booklyn Center | Minnesota | United States |
| Chaska | Minnesota | United States |
| Jackson | Mississippi | United States |
| Kansas | Mississippi | United States |
| Creve Cour | Missouri | United States |
| St Louis | Missouri | United States |
| Lebanon | New Hampshire | United States |
| Livingston | New Jersey | United States |
| New Brunswick | New Jersey | United States |
| Winston-Salem | North Carolina | United States |
| Fargo | North Dakota | United States |
| Jamestown | North Dakota | United States |
| Cincinnati | Ohio | United States |
| Columbus | Ohio | United States |
| Toledo | Ohio | United States |
| Oklahoma City | Oklahoma | United States |
| Medford | Oregon | United States |
| Erie | Pennsylvania | United States |
| Media | Pennsylvania | United States |
| West Reading | Pennsylvania | United States |
| Hilton Head Island | South Carolina | United States |
| Sioux Falls | South Dakota | United States |
| Nashville | Tennessee | United States |
| Dallas | Texas | United States |
| Denton | Texas | United States |
| Galveston | Texas | United States |
| San Antonio | Texas | United States |
| Salt Lake City | Utah | United States |
| Burlington | Vermont | United States |
| Norfolk | Virginia | United States |
| Richmond | Virginia | United States |
| Seattle | Washington | United States |
| ID | Term |
|---|---|
| C447119 | bazedoxifene |
| D004966 | Estrogens, Conjugated (USP) |
| ID | Term |
|---|---|
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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