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The Efficacy of ESTRATEST® Tablets in Relieving Menopausal Symptoms in Estrogenized, Hysterectomized Postmenopausal Women - Article


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Clinical Trial: The Efficacy of ESTRATEST® Tablets in Relieving Menopausal Symptoms in Estrogenized, Hysterectomized Postmenopausal Women

This study is currently recruiting patients.
Verified by Solvay Pharmaceuticals August 2005

Sponsored by: Solvay Pharmaceuticals
Information provided by: Solvay Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00141557

Purpose

To determine whether treatment with ESTRATEST® Tablets is superior to treatment with esterified estrogens tablets
Condition Intervention Phase
Menopause
  Drug: esterified estrogens 1.25mg and methyltestosterone 2.5mg
 Phase II

MedlinePlus consumer health information 

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

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

Eligibility

Ages Eligible for Study:  35 Years   -   65 Years,  Genders Eligible for Study:  Female
Criteria

Inclusion Criteria:

Hysterectomized, menopausal women between the ages of 30 and 65 years of age (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:

-

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00141557

Cindy Lane       cindy.lane@solvay.com

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

      Site 42, Houston,  Texas,  United States; Recruiting
See central contact

      Site 71, Dallas,  Texas,  United States; Recruiting
See central contact

      Site 74, Conroe,  Texas,  United States; Recruiting
See central contact

Utah
      Site 38, Salt Lake City,  Utah,  United States; Recruiting
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Virginia
      Site 12, Richmond,  Virginia,  United States; Recruiting
See central contact

      Site 28, Norfolk,  Virginia,  United States; Recruiting
See central contact

Washington
      Site 2, Seattle,  Washington,  United States; Recruiting
See central contact

      Site 43, Tacoma,  Washington,  United States; Recruiting
See central contact

      Site 48, Spokane,  Washington,  United States; Recruiting
See central contact

      Site 56, Renton,  Washington,  United States; Recruiting
See central contact

Study chairs or principal investigators

Global Clinical Director Solvay,  Study Director,  Solvay Pharmaceuticals   

More Information

Study ID Numbers:  S030.2.110
Last Updated:  August 31, 2005
Record first received:  August 30, 2005
ClinicalTrials.gov Identifier:  NCT00141557
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-06


Source: ClinicalTrials.gov
Cache Date: September 7, 2005


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