Efficacy Study Comparing 0.9 g and 1.25 g Estrogel With Placebo for Vasomotor Symptoms and Vulvar and Vaginal Atrophy
NCT ID: NCT00160173
Last Updated: 2022-09-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
221 participants
INTERVENTIONAL
2004-12-02
2005-09-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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EstroGel® Gel 0.9 grams 0.03%
0.9 g of EstroGel® 0.03% applied to one arm and 1.25 g of placebo gel applied on the other arm once daily for 12 weeks.
Estrogel
EstroGel® Gel 1.25 grams 0.03%
1.25 g of EstroGel® 0.03% applied to one arm and 0.9 g of placebo gel applied on the other arm once daily for 12 weeks.
Estrogel
Placebo Gel
0.9 g of placebo gel applied to one arm and 1.25 g of placebo gel applied on the other arm once daily for 12 weeks.
Placebo
Interventions
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Estrogel
Placebo
Eligibility Criteria
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Inclusion Criteria
* naturally or surgically postmenopausal
* experiencing hot flushes
Exclusion Criteria
* pregnancy or lactating
* abnormal PAP smear
* history/suspected cervical, uterine, adrenal, pituitary, breast or ovarian malignancy
45 Years
65 Years
FEMALE
No
Sponsors
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Solvay Pharmaceuticals
INDUSTRY
ASCEND Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Director Solvay
Role: STUDY_DIRECTOR
Solvay Pharmaceuticals
Locations
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Site 112
Birmingham, Alabama, United States
Site 74
Mobile, Alabama, United States
Site 20
Montgomery, Alabama, United States
Site 34
Tucson, Arizona, United States
Site 68
Tucson, Arizona, United States
Site 5
Jonesboro, Arkansas, United States
Site 88
Little Rock, Arkansas, United States
Site 95
Little Rock, Arkansas, United States
Site 104
Carmichael, California, United States
Site 42
Encinitas, California, United States
Site 21
San Diego, California, United States
Site 37
San Diego, California, United States
Site 78
San Diego, California, United States
Site 82
San Diego, California, United States
Site 69
Avon, Connecticut, United States
Site 58
Bridgeport, Connecticut, United States
Site 3
Groton, Connecticut, United States
Site 72
Hartford, Connecticut, United States
Site 54
New Britain, Connecticut, United States
Site 79
Southport, Connecticut, United States
Site 18
Waterbury, Connecticut, United States
Site 97
West Hartford, Connecticut, United States
Site 35
Aventura, Florida, United States
Site 36
Aventura, Florida, United States
Site 105
Clearwater, Florida, United States
Site 49
Clearwater, Florida, United States
Site 91
Daytona Beach, Florida, United States
Site 57
Melbourne, Florida, United States
Site 109
Miami, Florida, United States
Site 39
Pinellas Park, Florida, United States
Site 107
Spring Hill, Florida, United States
Site 100
Tampa, Florida, United States
Site 77
West Palm Beach, Florida, United States
Site 61
Alpharetta, Georgia, United States
Site 81
Alpharetta, Georgia, United States
Site 28
Atlanta, Georgia, United States
Site 93
Atlanta, Georgia, United States
Site 55
Decatur, Georgia, United States
Site 13
Douglasville, Georgia, United States
Site 87
Powder Springs, Georgia, United States
Site 22
Savannah, Georgia, United States
Site 99
Savannah, Georgia, United States
Site 53
Boise, Idaho, United States
Site 96
Champaign, Illinois, United States
Site 24
Chicago, Illinois, United States
Site 84
Chicago, Illinois, United States
Site 26
Peoria, Illinois, United States
Site 46
Peoria, Illinois, United States
Site 75
Evansville, Indiana, United States
Site 45
South Bend, Indiana, United States
Site 8
Waterloo, Iowa, United States
Site 108
Lexington, Kentucky, United States
Site 50
Baton Rouge, Louisiana, United States
Site 12
Metairie, Louisiana, United States
Site 65
New Orleans, Louisiana, United States
Site 16
Shreveport, Louisiana, United States
Site 11
Baltimore, Maryland, United States
Site 66
Ann Arbor, Michigan, United States
Site 15
Chaska, Minnesota, United States
Site 29
Creve Coeur, Missouri, United States
Site 2
St Louis, Missouri, United States
Site 67
St Louis, Missouri, United States
Site 19
Billings, Montana, United States
Site 56
Lincoln, Nebraska, United States
Site 6
Las Vegas, Nevada, United States
Site 40
Reno, Nevada, United States
Site102
Olean, New York, United States
Site 31
Fayetteville, North Carolina, United States
Site 60
New Bern, North Carolina, United States
Site 59
Raleigh, North Carolina, United States
Site 38
Winston-Salem, North Carolina, United States
Site 70
Winston-Salem, North Carolina, United States
Site 85
Winston-Salem, North Carolina, United States
Site 86
Cincinnati, Ohio, United States
Site 101
Edmond, Oklahoma, United States
Site 89
Eugene, Oregon, United States
Site 111
Medford, Oregon, United States
Site 64
Portland, Oregon, United States
Site 113
Erie, Pennsylvania, United States
Site 98
Pottstown, Pennsylvania, United States
Site 33
Greenville, South Carolina, United States
Site 9
Chattanooga, Tennessee, United States
Site 92
Memphis, Tennessee, United States
Site 76
Nashville, Tennessee, United States
Site 83
Carrollton, Texas, United States
Site 17
Conroe, Texas, United States
Site 23
Corpus Christi, Texas, United States
Site 25
Corpus Christi, Texas, United States
Site 30
Dallas, Texas, United States
Site 90
Dallas, Texas, United States
Site 10
Houston, Texas, United States
Site 110
Houston, Texas, United States
Site 14
Houston, Texas, United States
Site 27
Houston, Texas, United States
Site 48
Houston, Texas, United States
Site 51
Houston, Texas, United States
Site 71
Houston, Texas, United States
Site 73
Houston, Texas, United States
Site 43
San Antonio, Texas, United States
Site 62
San Antonio, Texas, United States
Site 80
San Antonio, Texas, United States
Site 7
Texarkana, Texas, United States
Site 44
Salt Lake City, Utah, United States
Site 94
Salt Lake City, Utah, United States
Site 47
Norfolk, Virginia, United States
Site 106
Richmond, Virginia, United States
Site 41
Richmond, Virginia, United States
Site 4
Seattle, Washington, United States
Site 52
Tacoma, Washington, United States
Countries
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Other Identifiers
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S166.4.003
Identifier Type: -
Identifier Source: org_study_id
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