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The purpose of this study is to determine whether bazedoxifene/conjugated estrogens combinations are effective in the treatment of moderate to severe vasomotor symptoms associated with menopause.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bazedoxifene/Conjugated Estrogen | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Number and severity of moderate and severe hot flashes at week 4 and at week 12, as reported daily on subject diary cards. |
| Measure | Description | Time Frame |
|---|---|---|
| Breast pain throughout the 12 week study, as reported daily on subject diary cards. Sleep scales and sleep quantity at week 4 and week 12, as indicated on a subject-completed questionnaire. |
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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 |
|---|---|---|---|---|---|---|
| Phoenix | Arizona | 85105 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27676118 | Derived | Archer DF, Freeman EW, Komm BS, Ryan KA, Yu CR, Mirkin S, Pinkerton JV. Pooled Analysis of the Effects of Conjugated Estrogens/Bazedoxifene on Vasomotor Symptoms in the Selective Estrogens, Menopause, and Response to Therapy Trials. J Womens Health (Larchmt). 2016 Nov;25(11):1102-1111. doi: 10.1089/jwh.2015.5558. Epub 2016 Sep 27. |
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| Fort Myers |
| Florida |
| 33916 |
| United States |
| North Port Richey | Florida | 34652 | United States |
| Scarborough | Maine | 04074 | United States |
| Albuquerque | New Mexico | 87102 | United States |
| Winston-Salem | North Carolina | 27103 | United States |
| Pottstown | Pennsylvania | 19464 | 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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