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

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

Sponsors

Lead Sponsor: Solvay Pharmaceuticals

Source Solvay Pharmaceuticals
Brief Summary

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

Overall Status Completed
Start Date June 2004
Completion Date June 2007
Primary Completion Date June 2007
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Change from baseline in the total score of the Menopause Rating Scale (MRS) at Week 12
Secondary Outcome
Measure 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
Enrollment 350
Condition
Intervention

Intervention Type: Drug

Intervention Name: esterified estrogens 0.625 mg and methyltestosterone 1.25 mg

Eligibility

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

Gender: Female

Minimum Age: 30 Years

Maximum Age: 65 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Global Clinical Director Solvay Study Director Solvay Pharmaceuticals
Location
Facility:
Site 66 | Huntsville, Alabama, United States
Site 57 | 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 | Ft. 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
Location Countries

United States

Verification Date

January 2009

Keywords
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Double

Source: ClinicalTrials.gov