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| ID | Type | Description | Link |
|---|---|---|---|
| 2005-002887-27 |
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This is a research study to evaluate the effectiveness, safety and side effects of several dose levels of esterified estrogens (EE) and methyltestosterone (MT) given individually and in combination compared to a placebo (a tablet with no active drug in it) as a possible treatment for vasomotor symptoms (such as hot flushes and flushing) of menopause. EE and testosterone are two hormones which are typically deficient in menopausal women
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator |
| |
| 2 | Experimental |
| |
| 3 | Experimental |
| |
| 4 | Active Comparator |
| |
| 5 | Experimental |
| |
| 6 | Experimental |
| |
| 7 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Esterified Estrogens (EE) and Methyltestosterone (MT) | Drug | oral tablet, QD, 12 weeks, 0.15 EE/0.15 MT |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in frequency of moderate to severe vasomotor symptoms (VMS) from baseline to Week 4 | 4 weeks | |
| Mean change in frequency of moderate to severe VMS from baseline to Week 12 | 12 weeks | |
| Mean change in severity of moderate to severe VMS from baseline to Week 4 | 4 weeks | |
| Mean change in severity of moderate to severe VMS from baseline to Week 12 | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency and severity of moderate to severe and all hot flushes at each week | 12 weeks | |
| Mean change from baseline to Week 12 in the moderate to severe vulvar and vaginal atrophy symptom identified by the subject as most bothersome | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Director Solvay | Solvay Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 37 | Montgomery | Alabama | United States | |||
| Site 69 |
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| 8 | Active Comparator |
|
| 9 | Placebo Comparator |
|
| Esterified Estrogens (EE) and Methyltestosterone (MT) | Drug | oral tablet, QD, 12 weeks, 0.15 EE/0.15 MT |
|
| Esterified Estrogens (EE) and Methyltestosterone (MT) | Drug | oral tablet, QD, 12 weeks, 0.15 EE/0.30 MT |
|
| Esterified Estrogens (EE) and Methyltestosterone (MT) | Drug | oral tablet, QD, 12 weeks, 0.30 EE/0.30 MT |
|
| Esterified Estrogens (EE) and Methyltestosterone (MT) | Drug | oral tablet, QD, 12 weeks, 0.30 EE |
|
| Esterified Estrogens (EE) and Methyltestosterone (MT) | Drug | oral tablet, QD, 12 weeks, 0.30 EE/0.60 MT |
|
| Esterified Estrogens (EE) and Methyltestosterone (MT) | Drug | oral tablet, QD, 12 weeks, 0.45 EE |
|
| Esterified Estrogens (EE) and Methyltestosterone (MT) | Drug | oral tablet, QD, 12 weeks, 0.60 MT |
|
| Esterified Estrogens (EE) and Methyltestosterone (MT) | Drug | oral tablet, QD, 12 weeks, Placebo |
|
| Mean change from baseline to Week 12 in vaginal pH | 12 weeks |
| Mean change from baseline to Week 12 in vaginal maturation index (parabasal and superficial cells) | 12 weeks |
| Montgomery |
| Alabama |
| United States |
| Site 44 | Tucson | Arizona | United States |
| Site 6 | Jonesboro | Arkansas | United States |
| Site 62 | Little Rock | Arkansas | United States |
| Site 70 | Carmichael | California | United States |
| Site 85 | Carmichael | California | United States |
| Site 87 | Northridge | California | United States |
| Site 18 | San Diego | California | United States |
| Site 27 | San Diego | California | United States |
| Site 54 | San Diego | California | United States |
| Site 31 | Vista | California | United States |
| Site 68 | Walnut Creek | California | United States |
| Site 66 | Denver | Colorado | United States |
| Site 4 | Groton | Connecticut | United States |
| Site 35 | New Britain | Connecticut | United States |
| Site 14 | Waterbury | Connecticut | United States |
| Site 25 | Aventura | Florida | United States |
| Site 26 | Aventura | Florida | United States |
| Site 51 | Clearwater | Florida | United States |
| Site 71 | Clearwater | Florida | United States |
| Site 61 | Daytona Beach | Florida | United States |
| Site 75 | Gainesville | Florida | United States |
| Site 33 | Pensacola | Florida | United States |
| Site 21 | Stuart | Florida | United States |
| Site 82 | Tampa | Florida | United States |
| Site 9 | Venice | Florida | United States |
| Site 83 | West Palm Beach | Florida | United States |
| Site 40 | Alpharetta | Georgia | United States |
| Site 90 | Alpharetta | Georgia | United States |
| Site 23 | Atlanta | Georgia | United States |
| Site 8 | Atlanta | Georgia | United States |
| Site 60 | Powder Springs | Georgia | United States |
| Site 55 | Savannah | Georgia | United States |
| Site 76 | Boise | Idaho | United States |
| Site 64 | Champaign | Illinois | United States |
| Site 58 | Chicago | Illinois | United States |
| Site 72 | Chicago | Illinois | United States |
| Site 74 | Chicago | Illinois | United States |
| Site 50 | Evansville | Indiana | United States |
| Site 52 | Baton Rouge | Louisiana | United States |
| Site 65 | Mandeville | Louisiana | United States |
| Site 73 | Metarie | Louisiana | United States |
| Site 15 | Lutherville | Maryland | United States |
| Site 43 | Ann Arbor | Michigan | United States |
| Site 12 | Chaska | Minnesota | United States |
| Site 80 | Chesterfield | Missouri | United States |
| Site 16 | Kansas City | Missouri | United States |
| Site 19 | Kansas City | Missouri | United States |
| Site 3 | St Louis | Missouri | United States |
| Site 17 | Billings | Montana | United States |
| Site 36 | Lincoln | Nebraska | United States |
| Site 7 | Las Vegas | Nevada | United States |
| Site 28 | Reno | Nevada | United States |
| Site 39 | New Bern | North Carolina | United States |
| Site 79 | Raleigh | North Carolina | United States |
| Site 46 | Winston-Salem | North Carolina | United States |
| Site 59 | Winston-Salem | North Carolina | United States |
| Site 45 | Cincinnati | Ohio | United States |
| Site 81 | Cincinnati | Ohio | United States |
| Site 53 | Columbus | Ohio | United States |
| Site 34 | Mayfield Heights | Ohio | United States |
| Site 78 | Mogadore | Ohio | United States |
| Site 77 | Tulsa | Oklahoma | United States |
| Site 13 | Portland | Oregon | United States |
| Site 89 | Portland | Oregon | United States |
| Site 84 | Philadelphia | Pennsylvania | United States |
| Site 63 | Pottstown | Pennsylvania | United States |
| Site 22 | Warwick | Rhode Island | United States |
| Site 24 | Greenville | South Carolina | United States |
| Site 67 | Hilton Head | South Carolina | United States |
| Site 10 | Chattanooga | Tennessee | United States |
| Site 88 | Memphis | Tennessee | United States |
| Site 56 | Nashville | Tennessee | United States |
| Site 86 | Bryan | Texas | United States |
| Site 20 | Corpus Christi | Texas | United States |
| Site 11 | Houston | Texas | United States |
| Site 30 | San Antonio | Texas | United States |
| Site 41 | San Antonio | Texas | United States |
| Site 49 | Salt Lake City | Utah | United States |
| Site 47 | Charlottesville | Virginia | United States |
| Site 2 | Norfolk | Virginia | United States |
| Site 29 | Richmond | Virginia | United States |
| Site 48 | Richmond | Virginia | United States |
| Site 42 | Virginia Beach | Virginia | United States |
| Site 5 | Seattle | Washington | United States |
| Site 38 | Spokane | Washington | United States |
| Site 32 | Tacoma | Washington | United States |
| Site 120 | Abbotsford British Columbia | British Columbia | Canada |
| Site 100 | North Vancouver | British Columbia | Canada |
| Site 135 | Victoria | British Columbia | Canada |
| Site 116 | West Vancouver | British Columbia | Canada |
| Site 122 | Winnipeg | Manitoba | Canada |
| Site 93 | Winnipeg | Manitoba | Canada |
| Site 111 | St. John's | Newfoundland and Labrador | Canada |
| Site 109 | Burlington | Ontario | Canada |
| Site 114 | Corunna | Ontario | Canada |
| Site 95 | Hamilton | Ontario | Canada |
| Site 115 | Kingston | Ontario | Canada |
| Site 107 | London | Ontario | Canada |
| Site 106 | Newmarket | Ontario | Canada |
| Site 137 | Ottawa | Ontario | Canada |
| Site 117 | Peterborough | Ontario | Canada |
| Site 113 | Sarnia | Ontario | Canada |
| Site 92 | Sarnia | Ontario | Canada |
| Site 96 | Strathroy | Ontario | Canada |
| Site 112 | Montreal | Quebec | Canada |
| Site 103 | Rimouski | Quebec | Canada |
| Site 119 | Sainte-Foy | Quebec | Canada |
| Site 94 | Sainte-Foy | Quebec | Canada |
| Site 91 | Shawinigan | Quebec | Canada |
| Site 105 | Sherbrooke | Quebec | Canada |
| Site 136 | Sherbrooke | Quebec | Canada |
| Site 124 | Moscow | Russia |
| Site 125 | Moscow | Russia |
| Site 126 | Moscow | Russia |
| Site 128 | Moscow | Russia |
| Site 129 | Moscow | Russia |
| Site 130 | Moscow | Russia |
| Site 132 | Moscow | Russia |
| Site 133 | Moscow | Russia |
| Site 127 | Saint Petersburg | Russia |
| Site 131 | Saint Petersburg | Russia |
| Site 134 | Saint Petersburg | Russia |
| Site 138 | Saint Petersburg | Russia |
| ID | Term |
|---|---|
| D019584 | Hot Flashes |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D042724 | Estrogens, Esterified (USP) |
| D008777 | Methyltestosterone |
| ID | Term |
|---|---|
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D013739 | Testosterone |
| D000737 | Androstenols |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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