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

This study has been terminated.
(Lack of enrollment)
Information provided by:
Solvay Pharmaceuticals Identifier:
First received: August 30, 2005
Last updated: April 10, 2008
Last verified: April 2008
To determine whether treatment with ESTRATEST® Tablets is superior to treatment with esterified estrogens tablets

Condition Intervention Phase
Drug: esterified estrogens 1.25 mg and methyltestosterone 2.5 mg
Drug: Esterified estrogens 1.25 mg
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (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, Non-Hysterectomized Postmenopausal Women

Resource links provided by NLM:

Further study details as provided by Solvay Pharmaceuticals:

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

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

Enrollment: 28
Study Start Date: July 2004
Study Completion Date: March 2008
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: esterified estrogens 1.25 mg and methyltestosterone 2.5 mg
ESTRATEST® administered orally QD
Active Comparator: 2 Drug: Esterified estrogens 1.25 mg
Esterified estrogens 1.25 mg administered orally QD


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

Inclusion Criteria:

Non-hysterectomized, menopausal women between the ages of 35 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

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Please refer to this study by its identifier: NCT00141544

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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
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Jonesboro, Arkansas, United States
Site 22
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Site 55
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Site 6
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Denver, Colorado, United States
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Site 54
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Site 10
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Site 78
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Site 73
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Site 51
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Site 49
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Site 64
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Site 27
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Site 11
Pinellas Park, Florida, United States
Site 75
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Site 69
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Site 70
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Site 17
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Site 50
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Site 5
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Site 44
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Site 77
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Site 9
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Site 7
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Site 47
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Site 24
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Site 20
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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
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Site 74
Conroe, Texas, United States
Site 8
Corpus Christi, Texas, United States
Site 71
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Site 42
Houston, Texas, United States
Site 14
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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
Study Director: Global Clinical Director Solvay Solvay Pharmaceuticals
  More Information

Responsible Party: Cindy Lane, Solvay Pharmaceuticals Identifier: NCT00141544     History of Changes
Other Study ID Numbers: S030.2.107
Study First Received: August 30, 2005
Last Updated: April 10, 2008

Keywords provided by Solvay Pharmaceuticals:
Menopause; Postmenopause; Estrogen; Hormone Therapy

Additional relevant MeSH terms:
Estrogens, Esterified (USP)
Testosterone 17 beta-cypionate
Testosterone enanthate
Testosterone undecanoate
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents
Androgens processed this record on April 28, 2017