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The purpose of this study is to evaluate the efficacy and safety of 100 mg and 150 mg of DVS SR, an extended release form of desvenlafaxine succinate, in comparison to placebo for the treatment of Vasomotor Symptoms (VMS) associated with menopause in a population of postmenopausal women.
To assess the efficacy and safety of 100 mg and 150 mg of DVS SR in comparison to placebo for the treatment of moderate to severe VMS associated with menopause, as well as additional outcome indicators such as sleep disruptions, overall climacteric symptoms, mood changes, somatic symptoms, and overall satisfaction with DVS SR in postmenopausal women.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Desvenlafaxine succinate sustained-release (DVS SR) | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| The number and severity of hot flushes collected throughout the study after 12 weeks of therapy. |
| Measure | Description | Time Frame |
|---|---|---|
| The number of awakenings due to VMS and the total mood disturbance score (Profile of Mood States [POMS]). | ||
| The scores on the Greene Climacteric Scale (GCS), the Visual Analog Scale-Pain Intensity (VAS-PI), and the Satisfaction Survey (SS). |
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Inclusion Criteria:
Other inclusions apply.
Exclusion Criteria:
Other exclusions apply.
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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 |
|---|---|---|---|---|---|---|
| Montgomery | Alabama | 36106 | United States | |||
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| Peoria |
| Arizona |
| 85381 |
| United States |
| Upland | California | 91786 | United States |
| Colorado Springs | Colorado | 80910 | United States |
| Brooksville | Florida | 34613 | United States |
| Inverness | Florida | 34452 | United States |
| Miami | Florida | 33143 | United States |
| New Port Richey | Florida | 34652 | United States |
| Ocala | Florida | 34471 | United States |
| St. Petersburg | Florida | 33709 | United States |
| Tampa | Florida | 33606 | United States |
| Decatur | Georgia | 30033 | United States |
| Savannah | Georgia | 31406 | United States |
| Boise | Idaho | 83702 | United States |
| Idaho Falls | Idaho | 83404 | United States |
| Overland Park | Kansas | 66210 | United States |
| Louisville | Kentucky | 40291 | United States |
| Portland | Maine | 04102 | United States |
| Rockville | Maryland | 20852 | United States |
| Billings | Montana | 59102 | United States |
| Las Vegas | Nevada | 89146 | United States |
| Albuquerque | New Mexico | 87102 | United States |
| Winston-Salem | North Carolina | 27103 | United States |
| Bismarck | North Dakota | 58501 | United States |
| Fargo | North Dakota | 58104 | United States |
| Cincinnati | Ohio | 45267-0457 | United States |
| Eugene | Oregon | 97401 | United States |
| Erie | Pennsylvania | 16502 | United States |
| Philadelphia | Pennsylvania | 19114 | United States |
| Wexford | Pennsylvania | 15090 | United States |
| Hilton Head Island | South Carolina | 29926 | United States |
| Midvale | Utah | 84047 | United States |
| Norfolk | Virginia | 23507 | United States |
| Richmond | Virginia | 23294 | United States |