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Trial record 21 of 23 for:    Estropipate

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

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ClinicalTrials.gov Identifier: NCT00141557
Recruitment Status : Terminated (Lack of enrollment)
First Posted : September 1, 2005
Last Update Posted : April 11, 2008
Sponsor:
Information provided by:
Solvay Pharmaceuticals

Brief Summary:
To determine whether treatment with ESTRATEST® Tablets is superior to treatment with esterified estrogens tablets

Condition or disease Intervention/treatment Phase
Menopause Drug: esterified estrogens 1.25mg and methyltestosterone 2.5mg Drug: Esterified estrogens 1.25 mg Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 133 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multi-Center, Double-Blind Study to Determine the Efficacy of ESTRATEST® Tablets in Relieving Menopausal Symptoms in Estrogenized, Hysterectomized Postmenopausal Women
Study Start Date : July 2004
Actual Primary Completion Date : April 2007
Actual Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Menopause
Drug Information available for: Estrogens

Arm Intervention/treatment
Experimental: 1 Drug: esterified estrogens 1.25mg and methyltestosterone 2.5mg
ESTRATEST® administered orally QD

Active Comparator: 2 Drug: Esterified estrogens 1.25 mg
Esterified estrogens 1.25 mg administered orally QD




Primary Outcome Measures :
  1. Change from baseline in the total score of the Menopause Rating Scale (MRS) [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Change from baseline in the domain and individual item scores of the MRS [ Time Frame: 12 weeks ]
  2. Change from baseline in the domain scores of the MENQOL [ Time Frame: monthly for 3 months ]
  3. Comparison of changes in hormone levels and correlation with changes in the MRS [ Time Frame: 12 weeks ]


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Ages Eligible for Study:   35 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00141557


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Locations
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United States, Alabama
Site 66
Huntsville, Alabama, United States
Site 57
Mobile, Alabama, United States
Site 46
Montgomery, Alabama, United States
United States, Arizona
Site 29
Phoenix, Arizona, United States
Site 15
Tucson, Arizona, United States
United States, Arkansas
Site 3
Jonesboro, Arkansas, United States
Site 22
Little Rock, Arkansas, United States
United States, California
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
United States, Colorado
Site 26
Denver, Colorado, United States
United States, Connecticut
Site 1
Groton, Connecticut, United States
Site 54
Hartford, Connecticut, United States
Site 30
Trumbull, Connecticut, United States
Site 34
Waterbury, Connecticut, United States
United States, Florida
Site 10
Aventura, Florida, United States
Site 78
Clearwater, 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
United States, Georgia
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
United States, Idaho
Site 47
Boise, Idaho, United States
United States, Illinois
Site 24
Champaign, Illinois, United States
Site 20
Chicago, Illinois, United States
Site 76
Peoria, Illinois, United States
United States, Indiana
Site 58
Evansville, Indiana, United States
United States, Kansas
Site 39
Wichita, Kansas, United States
United States, Louisiana
Site 59
Baton Rouge, Louisiana, United States
Site 52
New Orleans, Louisiana, United States
United States, Michigan
Site 53
Ann Arbor, Michigan, United States
United States, Missouri
Site 63
Kansas City, Missouri, United States
Site 32
Richmond Heights, Missouri, United States
Site 36
St. Louis, Missouri, United States
United States, Montana
Site 72
Billings, Montana, United States
United States, Nebraska
Site 21
Lincoln, Nebraska, United States
United States, Nevada
Site 37
Reno, Nevada, United States
United States, North Carolina
Site 65
Cary, North Carolina, United States
Site 13
New Bern, North Carolina, United States
Site 16
Winston-Salem, North Carolina, United States
United States, Ohio
Site 60
Columbus, Ohio, United States
United States, Oklahoma
Site 67
Oklahoma City, Oklahoma, United States
Site 40
Tulsa, Oklahoma, United States
United States, Oregon
Site 62
Eugene, Oregon, United States
Site 41
Medford, Oregon, United States
Site 33
Portland, Oregon, United States
United States, Pennsylvania
Site 18
Erie, Pennsylvania, United States
Site 19
Philadelphia, Pennsylvania, United States
Site 23
Pottstown, Pennsylvania, United States
United States, South Carolina
Site 31
Anderson, South Carolina, United States
Site 35
Greer, South Carolina, United States
United States, Tennessee
Site 4
Chattanooga, Tennessee, United States
United States, Texas
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
United States, Utah
Site 38
Salt Lake City, Utah, United States
United States, Virginia
Site 28
Norfolk, Virginia, United States
Site 12
Richmond, Virginia, United States
United States, Washington
Site 56
Renton, Washington, United States
Site 2
Seattle, Washington, United States
Site 48
Spokane, Washington, United States
Site 43
Tacoma, Washington, United States
Sponsors and Collaborators
Solvay Pharmaceuticals
Investigators
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Study Director: Global Clinical Director Solvay Solvay Pharmaceuticals

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Responsible Party: Cindy Lane, Solvay Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00141557     History of Changes
Other Study ID Numbers: S030.2.110
First Posted: September 1, 2005    Key Record Dates
Last Update Posted: April 11, 2008
Last Verified: April 2008
Keywords provided by Solvay Pharmaceuticals:
Menopause; Postmenopause; Estrogen; Hormone Therapy
Additional relevant MeSH terms:
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Estrone
Methyltestosterone
Estrogens
Estrogens, Esterified (USP)
Testosterone
Testosterone undecanoate
Testosterone enanthate
Testosterone 17 beta-cypionate
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents
Androgens