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The purpose of this study is to assess the efficacy and safety of 4 doses of desvenlafaxine-233 sustained release (DVS-233 SR) as compared to placebo for the treatment of moderate to severe vasomotor symptoms associated with menopause, as well as its influence on sleep parameters and other health outcomes indicators.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DVS-233 SR | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| The primary objective is to assess the efficacy and safety of 4 doses of DVS-233 SR as compared to placebo for the treatment of moderate to severe VMS associated with menopause. |
| Measure | Description | Time Frame |
|---|---|---|
| The secondary objectives are to assess the effects of DVS-233 SR as compared to placebo on sleep parameters and on health outcomes indicators |
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Inclusion Criteria:
Generally healthy, postmenopausal women; at least 12 months of spontaneous amenorrhea or at least 6 months of spontaneous amenorrhea with serum FSH levels > 40 mIU/mL or at least 6 weeks postsurgical bilateral oophorectomy (with or without hysterectomy).
Minimum of 7 moderate to severe hot flushes per day or 50 moderate to severe hot flushes per week at screening:
Subjects must have body mass index (BMI) less than or equal to 40 using the nomograph for BMI.
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 |
|---|---|---|---|---|---|---|
| Montgomery | Alabama | 36116 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18165395 | Derived | Speroff L, Gass M, Constantine G, Olivier S; Study 315 Investigators. Efficacy and tolerability of desvenlafaxine succinate treatment for menopausal vasomotor symptoms: a randomized controlled trial. Obstet Gynecol. 2008 Jan;111(1):77-87. doi: 10.1097/01.AOG.0000297371.89129.b3. |
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| Peoria |
| Arizona |
| 85345 |
| United States |
| San Diego | California | 92123 | United States |
| Stanford | California | 94143 | United States |
| Colorado Springs | Colorado | 80907 | United States |
| Newark | Delaware | 19713 | United States |
| Aventura | Florida | 33160 | United States |
| Fort Myers | Florida | 33990 | United States |
| Inverness | Florida | 34452 | United States |
| Miami | Florida | 33143 | United States |
| New Port Richey | Florida | 32701 | United States |
| Ocala | Florida | 34470 | United States |
| Orange City | Florida | 32763 | United States |
| Pinellas Park | Florida | 33781 | United States |
| Tampa | Florida | 33709 | United States |
| West Palm Beach | Florida | 33409 | United States |
| West Venice | Florida | 34285 | United States |
| Atlanta | Georgia | 30342 | United States |
| Savannah | Georgia | 31405 | United States |
| Newburgh | Indiana | 47630 | United States |
| Lexington | Kentucky | 40536 | United States |
| Shreveport | Louisiana | 71103 | United States |
| Portland | Maine | 04102 | United States |
| Chaska | Minnesota | 55387 | United States |
| Jackson | Mississippi | 39216 | United States |
| St Louis | Missouri | 63131 | United States |
| Billings | Montana | 59101 | United States |
| Las Vegas | Nevada | 89119 | United States |
| Reno | Nevada | 89509 | United States |
| Albuquerque | New Mexico | 87102 | United States |
| Albuquerque | New Mexico | 87131 | United States |
| Winston-Salem | North Carolina | 27103 | United States |
| Canton | Ohio | 44406 | United States |
| Cincinnati | Ohio | 45249 | United States |
| Cincinnati | Ohio | 45267 | United States |
| Portland | Oregon | 97201 | United States |
| Erie | Pennsylvania | 16502 | United States |
| Wexford | Pennsylvania | 15090 | United States |
| Greenville | South Carolina | 29605 | United States |
| San Antonio | Texas | 78229 | United States |
| Norfolk | Virginia | 23507 | United States |