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

This study has been terminated.
(Lack of enrollment)
Sponsor:
Information provided by:
Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00141544
First received: August 30, 2005
Last updated: April 10, 2008
Last verified: April 2008
  Purpose

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


Condition Intervention Phase
Menopause
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in the domain and individual item scores of the MRS [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in the domain scores of the MENQOL [ Time Frame: monthly for 3 months ] [ Designated as safety issue: No ]
  • Comparison of changes in hormone levels and correlation with changes in the MRS [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   35 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00141544

  Hide Study Locations
Locations
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
Study Director: Global Clinical Director Solvay Solvay Pharmaceuticals
  More Information

No publications provided

Responsible Party: Cindy Lane, Solvay Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00141544     History of Changes
Other Study ID Numbers: S030.2.107
Study First Received: August 30, 2005
Last Updated: April 10, 2008
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Estrogens
Estrogens, Esterified (USP)
Estrone
Methyltestosterone
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anabolic Agents
Androgens

ClinicalTrials.gov processed this record on September 18, 2014