To determine whether treatment with ESTRATEST® H.S. Tablets is superior to treatment with esterified estrogens tablets

Condition	Intervention	Phase
Menopause	Drug: esterified estrogens 0.625 mg and methyltestosterone 1.25 mg	Phase II

Ages Eligible for Study:  30 Years   -   65 Years,  Genders Eligible for Study:  Female

Criteria

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

Exclusion Criteria:

-

Alabama
      Site 46, Montgomery,  Alabama,  United States
      Site 57, Mobile,  Alabama,  United States
      Site 66, Huntsville,  Alabama,  United States
Arizona
      Site 15, Tucson,  Arizona,  United States
      Site 29, Phoenix,  Arizona,  United States
Arkansas
      Site 3, Jonesboro,  Arkansas,  United States
      Site 22, Little Rock,  Arkansas,  United States
California
      Site 6, San Diego,  California,  United States
      Site 25, Walnut Creek,  California,  United States
      Site 45, Santa Rosa,  California,  United States
      Site 55, Encinitas,  California,  United States
      Site 68, Carmichael,  California,  United States
Colorado
      Site 26, Denver,  Colorado,  United States
Connecticut
      Site 1, Groton,  Connecticut,  United States
      Site 30, Trumbull,  Connecticut,  United States
      Site 34, Waterbury,  Connecticut,  United States
      Site 54, Hartford,  Connecticut,  United States
Florida
      Site 10, Aventura,  Florida,  United States
      Site 11, Pinellas Park,  Florida,  United States
      Site 17, West Palm Beach,  Florida,  United States
      Site 27, Palm Springs,  Florida,  United States
      Site 49, Melbourne,  Florida,  United States
      Site 51, Leesburg,  Florida,  United States
      Site 61, Ocala,  Florida,  United States
      Site 64, New Port Richey,  Florida,  United States
      Site 69, St. Petersburg,  Florida,  United States
      Site 70, Venice,  Florida,  United States
      Site 73, Ft. Myers,  Florida,  United States
      Site 75, Sarasota,  Florida,  United States
Georgia
      Site 5, Atlanta,  Georgia,  United States
      Site 7, Savannah,  Georgia,  United States
      Site 9, Riverdale,  Georgia,  United States
      Site 44, Decatur,  Georgia,  United States
      Site 50, Alpharetta,  Georgia,  United States
      Site 77, Douglasville,  Georgia,  United States
Idaho
      Site 47, Boise,  Idaho,  United States
Illinois
      Site 20, Chicago,  Illinois,  United States
      Site 24, Champaign,  Illinois,  United States
      Site 76, Peoria,  Illinois,  United States
Indiana
      Site 58, Evansville,  Indiana,  United States
Kansas
      Site 39, Wichita,  Kansas,  United States
Louisiana
      Site 52, New Orleans,  Louisiana,  United States
      Site 59, Baton Rouge,  Louisiana,  United States
Michigan
      Site 53, Ann Arbor,  Michigan,  United States
Missouri
      Site 32, Richmond Heights,  Missouri,  United States
      Site 36, St. Louis,  Missouri,  United States
      Site 63, Kansas City,  Missouri,  United States
Montana
      Site 72, Billings,  Montana,  United States
Nebraska
      Site 21, Lincoln,  Nebraska,  United States
Nevada
      Site 37, Reno,  Nevada,  United States
North Carolina
      Site 13, New Bern,  North Carolina,  United States
      Site 16, Winston Salem,  North Carolina,  United States
      Site 65, Cary,  North Carolina,  United States
Ohio
      Site 60, Columbus,  Ohio,  United States
Oklahoma
      Site 40, Tulsa,  Oklahoma,  United States
      Site 67, Oklahoma City,  Oklahoma,  United States
Oregon
      Site 33, Portland,  Oregon,  United States
      Site 41, Medford,  Oregon,  United States
      Site 62, Eugene,  Oregon,  United States
Pennsylvania
      Site 18, Erie,  Pennsylvania,  United States
      Site 19, Philadelphia,  Pennsylvania,  United States
      Site 23, Pottstown,  Pennsylvania,  United States
South Carolina
      Site 31, Anderson,  South Carolina,  United States
      Site 35, Greer,  South Carolina,  United States
Tennessee
      Site 4, Chattanooga,  Tennessee,  United States
Texas
      Site 8, Corpus Christi,  Texas,  United States
      Site 14, San Antonio,  Texas,  United States
      Site 42, Houston,  Texas,  United States
      Site 71, Dallas,  Texas,  United States
      Site 74, Conroe,  Texas,  United States
Utah
      Site 38, Salt Lake City,  Utah,  United States
Virginia
      Site 12, Richmond,  Virginia,  United States
      Site 28, Norfolk,  Virginia,  United States
Washington
      Site 2, Seattle,  Washington,  United States
      Site 43, Tacoma,  Washington,  United States
      Site 48, Spokane,  Washington,  United States
      Site 56, Renton,  Washington,  United States

Study chairs or principal investigators

Global Clinical Director Solvay,  Study Director,  Solvay Pharmaceuticals   

Study ID Numbers:  S030.2.106
Last Updated:  August 31, 2005
Record first received:  August 30, 2005
ClinicalTrials.gov Identifier:  NCT00141570
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-13