Study Stopped
Lack of enrollment
The Efficacy of ESTRATEST® Tablets in Relieving Menopausal Symptoms in Estrogenized, Non-Hysterectomized Postmenopausal Women
A Multi-Center, Double-Blind Study to Determine the Efficacy of ESTRATEST® Tablets in Relieving Menopausal Symptoms in Estrogenized, Non-Hysterectomized Postmenopausal Women
1 other identifier
interventional
28
1 country
78
Brief Summary
To determine whether treatment with ESTRATEST® Tablets is superior to treatment with esterified estrogens tablets
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jul 2004
Typical duration for phase_2
78 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2004
CompletedFirst Submitted
Initial submission to the registry
August 30, 2005
CompletedFirst Posted
Study publicly available on registry
September 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2008
CompletedApril 11, 2008
April 1, 2008
2.8 years
August 30, 2005
April 10, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in the total score of the Menopause Rating Scale (MRS)
12 weeks
Secondary Outcomes (3)
Change from baseline in the domain and individual item scores of the MRS
12 weeks
Change from baseline in the domain scores of the MENQOL
monthly for 3 months
Comparison of changes in hormone levels and correlation with changes in the MRS
12 weeks
Study Arms (2)
1
EXPERIMENTAL2
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (78)
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 78
Clearwater, Florida, United States
Site 73
Fort 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
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Global Clinical Director Solvay
Solvay Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 30, 2005
First Posted
September 1, 2005
Study Start
July 1, 2004
Primary Completion
April 1, 2007
Study Completion
March 1, 2008
Last Updated
April 11, 2008
Record last verified: 2008-04