Efficacy Study Comparing 0.9 g and 1.25 g Estrogel With Placebo for Vasomotor Symptoms and Vulvar and Vaginal Atrophy

Phase 4

Completed

Conditions: Postmenopausal Symptoms

Interventions: Other: Placebo
Drug: Estrogel

Registration Number: NCT00160173

Lead Sponsor: ASCEND Therapeutics

Brief Summary: This study is intended to establish the lowest effective dose of EstroGel® for the treatment of vasomotor symptoms associated with menopause.

Detailed Description: The primary objective of this study was to establish the lowest effective dose of EstroGel® for the treatment of vasomotor symptoms associated with menopause by comparing the efficacy of 0.9 g and 1.25 g EstroGel® 0.03% doses with placebo. Effects on symptoms of vulvar and vaginal atrophy were assessed as secondary efficacy parameters.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 221

Inclusion Criteria

Women 45-65 years
naturally or surgically postmenopausal
experiencing hot flushes

Exclusion Criteria

hypersensitivity to estrogen replacement therapy
pregnancy or lactating
abnormal PAP smear
history/suspected cervical, uterine, adrenal, pituitary, breast or ovarian malignancy

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Gel	Placebo	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.
EstroGel® Gel 0.9 grams 0.03%	Estrogel	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® Gel 1.25 grams 0.03%	Estrogel	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.

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (109): Site 93
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Atlanta, Georgia, United States
Site 36
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Aventura, Florida, United States
Site 11
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Baltimore, Maryland, United States
Site 90
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Dallas, Texas, United States
Site 25
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Corpus Christi, Texas, United States
Site 10
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Houston, Texas, United States
Site 110
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Houston, Texas, United States
Site 14
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Houston, Texas, United States
Site 27
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Houston, Texas, United States
Site 48
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Houston, Texas, United States
Site 51
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Houston, Texas, United States
Site 71
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Houston, Texas, United States
Site 4
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Seattle, Washington, United States
Site 21
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San Diego, California, United States
Site 37
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San Diego, California, United States
Site 78
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San Diego, California, United States
Site 6
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Las Vegas, Nevada, United States
Site 86
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Cincinnati, Ohio, United States
Site 74
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Mobile, Alabama, United States
Site 58
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Bridgeport, Connecticut, United States
Site 72
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Hartford, Connecticut, United States
Site 3
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Groton, Connecticut, United States
Site 82
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San Diego, California, United States
Site 104
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Carmichael, California, United States
Site 8
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Waterloo, Iowa, United States
Site 45
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South Bend, Indiana, United States
Site 62
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San Antonio, Texas, United States
Site 80
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San Antonio, Texas, United States
Site 44
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Salt Lake City, Utah, United States
Site 94
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Salt Lake City, Utah, United States
Site 112
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Birmingham, Alabama, United States
Site 64
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Portland, Oregon, United States
Site 20
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Montgomery, Alabama, United States
Site 34
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Tucson, Arizona, United States
Site 5
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Jonesboro, Arkansas, United States
Site 68
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Tucson, Arizona, United States
Site 88
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Little Rock, Arkansas, United States
Site 95
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Little Rock, Arkansas, United States
Site 42
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Encinitas, California, United States
Site 69
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Avon, Connecticut, United States
Site 54
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New Britain, Connecticut, United States
Site 18
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Waterbury, Connecticut, United States
Site 35
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Aventura, Florida, United States
Site 97
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West Hartford, Connecticut, United States
Site 105
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Clearwater, Florida, United States
Site 49
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Clearwater, Florida, United States
Site 91
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Daytona Beach, Florida, United States
Site 57
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Melbourne, Florida, United States
Site 39
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Pinellas Park, Florida, United States
Site 107
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Spring Hill, Florida, United States
Site 109
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Miami, Florida, United States
Site 81
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Alpharetta, Georgia, United States
Site 77
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West Palm Beach, Florida, United States
Site 28
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Atlanta, Georgia, United States
Site 61
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Alpharetta, Georgia, United States
Site 55
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Decatur, Georgia, United States
Site 13
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Douglasville, Georgia, United States
Site 53
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Boise, Idaho, United States
Site 87
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Powder Springs, Georgia, United States
Site 96
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Champaign, Illinois, United States
Site 84
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Chicago, Illinois, United States
Site 22
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Savannah, Georgia, United States
Site 26
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Peoria, Illinois, United States
Site 46
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Peoria, Illinois, United States
Site 99
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Savannah, Georgia, United States
Site 24
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Chicago, Illinois, United States
Site 75
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Evansville, Indiana, United States
Site 16
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Shreveport, Louisiana, United States
Site 108
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Lexington, Kentucky, United States
Site 50
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Baton Rouge, Louisiana, United States
Site 65
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New Orleans, Louisiana, United States
Site 19
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Billings, Montana, United States
Site 15
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Chaska, Minnesota, United States
Site 29
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Creve Coeur, Missouri, United States
Site 2
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Saint Louis, Missouri, United States
Site 56
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Lincoln, Nebraska, United States
Site 40
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Reno, Nevada, United States
Site102
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Olean, New York, United States
Site 31
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Fayetteville, North Carolina, United States
Site 38
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Winston-Salem, North Carolina, United States
Site 60
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New Bern, North Carolina, United States
Site 59
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Raleigh, North Carolina, United States
Site 85
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Winston-Salem, North Carolina, United States
Site 70
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Winston-Salem, North Carolina, United States
Site 101
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Edmond, Oklahoma, United States
Site 89
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Eugene, Oregon, United States
Site 111
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Medford, Oregon, United States
Site 98
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Pottstown, Pennsylvania, United States
Site 113
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Erie, Pennsylvania, United States
Site 92
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Memphis, Tennessee, United States
Site 83
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Carrollton, Texas, United States
Site 17
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Conroe, Texas, United States
Site 23
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Corpus Christi, Texas, United States
Site 9
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Chattanooga, Tennessee, United States
Site 33
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Greenville, South Carolina, United States
Site 76
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Nashville, Tennessee, United States
Site 73
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Houston, Texas, United States
Site 43
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San Antonio, Texas, United States
Site 7
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Texarkana, Texas, United States
Site 47
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Norfolk, Virginia, United States
Site 106
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Richmond, Virginia, United States
Site 41
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Richmond, Virginia, United States
Site 66
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Ann Arbor, Michigan, United States
Site 67
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Saint Louis, Missouri, United States
Site 52
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Tacoma, Washington, United States
Site 79
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Southport, Connecticut, United States
Site 100
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Tampa, Florida, United States
Site 30
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Dallas, Texas, United States
Site 12
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Metairie, Louisiana, United States

Efficacy Study Comparing 0.9 g and 1.25 g Estrogel With Placebo for Vasomotor Symptoms and Vulvar and Vaginal Atrophy

Recruitment & Eligibility

Study & Design

Trial Locations

Instant Trial Alerts

Instant Trial Alerts