Study of the Efficacy of ESTRATEST® H.S. Tablets in Relieving Menopausal Symptoms in Estrogenized Postmenopausal Women

Condition(s) targeted: Menopause

Intervention: esterified estrogens 0.625 mg and methyltestosterone 1.25 mg (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Solvay Pharmaceuticals

Official(s) and/or principal investigator(s):
Global Clinical Director Solvay, Study Director, Affiliation: Solvay Pharmaceuticals

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

Official title: A Multi-Center, Double-Blind Study to Determine the Efficacy of ESTRATEST® H.S. Tablets in Relieving Menopausal Symptoms in Estrogenized Postmenopausal Women

Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Change from baseline in the total score of the Menopause Rating Scale (MRS) at Week 12

Secondary outcome: 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

Minimum age: 30 Years. Maximum age: 65 Years. Gender(s): 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

Site 46, Montgomery, Alabama, United States

Site 57, Mobile, Alabama, United States

Site 66, Huntsville, Alabama, United States

Site 15, Tucson, Arizona, United States

Site 29, Phoenix, Arizona, United States

Site 3, Jonesboro, Arkansas, United States

Site 22, Little Rock, Arkansas, United States

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

Site 26, Denver, Colorado, United States

Site 1, Groton, Connecticut, United States

Site 30, Trumbull, Connecticut, United States

Site 34, Waterbury, Connecticut, United States

Site 54, Hartford, Connecticut, United States

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

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

Site 47, Boise, Idaho, United States

Site 20, Chicago, Illinois, United States

Site 24, Champaign, Illinois, United States

Site 76, Peoria, Illinois, United States

Site 58, Evansville, Indiana, United States

Site 39, Wichita, Kansas, United States

Site 52, New Orleans, Louisiana, United States

Site 59, Baton Rouge, Louisiana, United States

Site 53, Ann Arbor, Michigan, United States

Site 32, Richmond Heights, Missouri, United States

Site 36, St. Louis, Missouri, United States

Site 63, Kansas City, Missouri, United States

Site 72, Billings, Montana, United States

Site 21, Lincoln, Nebraska, United States

Site 37, Reno, Nevada, United States

Site 13, New Bern, North Carolina, United States

Site 16, Winston-Salem, North Carolina, United States

Site 65, Cary, North Carolina, United States

Site 60, Columbus, Ohio, United States

Site 40, Tulsa, Oklahoma, United States

Site 67, Oklahoma City, Oklahoma, United States

Site 33, Portland, Oregon, United States

Site 41, Medford, Oregon, United States

Site 62, Eugene, 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 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

Site 38, Salt Lake City, Utah, United States

Site 12, Richmond, Virginia, United States

Site 28, Norfolk, Virginia, United States

Site 2, Seattle, Washington, United States

Site 43, Tacoma, Washington, United States

Site 48, Spokane, Washington, United States

Site 56, Renton, Washington, United States

Starting date: June 2004
Last updated: July 13, 2007