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To determine whether treatment with ESTRATEST® H.S. Tablets is superior to treatment with esterified estrogens tablets
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| esterified estrogens 0.625 mg and methyltestosterone 1.25 mg | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in the total score of the Menopause Rating Scale (MRS) at Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in the MRS at Week 12 & monthly change from baseline to Week 12 in the MENQOL; Comparison of changes in SHBG & testosterone & how these changes correlate with the MRS |
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Inclusion Criteria:
Menopausal women between the ages of 30 and 65 years (inclusive) with symptoms of estrogen and/or androgen deficiency not currently controlled by estrogen therapy as determined by patient report and the Investigator's clinical judgement
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Director Solvay | Solvay Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 66 | Huntsville | Alabama | United States | |||
| Site 57 |
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| Mobile |
| Alabama |
| United States |
| Site 46 | Montgomery | Alabama | United States |
| Site 29 | Phoenix | Arizona | United States |
| Site 15 | Tucson | Arizona | United States |
| Site 3 | Jonesboro | Arkansas | United States |
| Site 22 | Little Rock | Arkansas | United States |
| Site 68 | Carmichael | California | United States |
| Site 55 | Encinitas | California | United States |
| Site 6 | San Diego | California | United States |
| Site 45 | Santa Rosa | California | United States |
| Site 25 | Walnut Creek | California | United States |
| Site 26 | Denver | Colorado | United States |
| Site 1 | Groton | Connecticut | United States |
| Site 54 | Hartford | Connecticut | United States |
| Site 30 | Trumbull | Connecticut | United States |
| Site 34 | Waterbury | Connecticut | United States |
| Site 10 | Aventura | Florida | United States |
| Site 73 | Fort Myers | Florida | United States |
| Site 51 | Leesburg | Florida | United States |
| Site 49 | Melbourne | Florida | United States |
| Site 64 | New Port Richey | Florida | United States |
| Site 61 | Ocala | Florida | United States |
| Site 27 | Palm Springs | Florida | United States |
| Site 11 | Pinellas Park | Florida | United States |
| Site 75 | Sarasota | Florida | United States |
| Site 69 | St. Petersburg | Florida | United States |
| Site 70 | Venice | Florida | United States |
| Site 17 | West Palm Beach | Florida | United States |
| Site 50 | Alpharetta | Georgia | United States |
| Site 5 | Atlanta | Georgia | United States |
| Site 44 | Decatur | Georgia | United States |
| Site 77 | Douglasville | Georgia | United States |
| Site 9 | Riverdale | Georgia | United States |
| Site 7 | Savannah | Georgia | United States |
| Site 47 | Boise | Idaho | United States |
| Site 24 | Champaign | Illinois | United States |
| Site 20 | Chicago | Illinois | United States |
| Site 76 | Peoria | Illinois | United States |
| Site 58 | Evansville | Indiana | United States |
| Site 39 | Wichita | Kansas | United States |
| Site 59 | Baton Rouge | Louisiana | United States |
| Site 52 | New Orleans | Louisiana | United States |
| Site 53 | Ann Arbor | Michigan | United States |
| Site 63 | Kansas City | Missouri | United States |
| Site 32 | Richmond Heights | Missouri | United States |
| Site 36 | St Louis | Missouri | United States |
| Site 72 | Billings | Montana | United States |
| Site 21 | Lincoln | Nebraska | United States |
| Site 37 | Reno | Nevada | United States |
| Site 65 | Cary | North Carolina | United States |
| Site 13 | New Bern | North Carolina | United States |
| Site 16 | Winston-Salem | North Carolina | United States |
| Site 60 | Columbus | Ohio | United States |
| Site 67 | Oklahoma City | Oklahoma | United States |
| Site 40 | Tulsa | Oklahoma | United States |
| Site 62 | Eugene | Oregon | United States |
| Site 41 | Medford | Oregon | United States |
| Site 33 | Portland | Oregon | United States |
| Site 18 | Erie | Pennsylvania | United States |
| Site 19 | Philadelphia | Pennsylvania | United States |
| Site 23 | Pottstown | Pennsylvania | United States |
| Site 31 | Anderson | South Carolina | United States |
| Site 35 | Greer | South Carolina | United States |
| Site 4 | Chattanooga | Tennessee | United States |
| Site 74 | Conroe | Texas | United States |
| Site 8 | Corpus Christi | Texas | United States |
| Site 71 | Dallas | Texas | United States |
| Site 42 | Houston | Texas | United States |
| Site 14 | San Antonio | Texas | United States |
| Site 38 | Salt Lake City | Utah | United States |
| Site 28 | Norfolk | Virginia | United States |
| Site 12 | Richmond | Virginia | United States |
| Site 56 | Renton | Washington | United States |
| Site 2 | Seattle | Washington | United States |
| Site 48 | Spokane | Washington | United States |
| Site 43 | Tacoma | Washington | United States |
| 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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