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

Primary Purpose

Postmenopausal Symptoms

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Estrogel
Placebo
Sponsored by
ASCEND Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postmenopausal Symptoms focused on measuring Post menopausal vasomotor symptoms

Eligibility Criteria

45 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Site 112
  • Site 74
  • Site 20
  • Site 34
  • Site 68
  • Site 5
  • Site 88
  • Site 95
  • Site 104
  • Site 42
  • Site 21
  • Site 37
  • Site 78
  • Site 82
  • Site 69
  • Site 58
  • Site 3
  • Site 72
  • Site 54
  • Site 79
  • Site 18
  • Site 97
  • Site 35
  • Site 36
  • Site 105
  • Site 49
  • Site 91
  • Site 57
  • Site 109
  • Site 39
  • Site 107
  • Site 100
  • Site 77
  • Site 61
  • Site 81
  • Site 28
  • Site 93
  • Site 55
  • Site 13
  • Site 87
  • Site 22
  • Site 99
  • Site 53
  • Site 96
  • Site 24
  • Site 84
  • Site 26
  • Site 46
  • Site 75
  • Site 45
  • Site 8
  • Site 108
  • Site 50
  • Site 12
  • Site 65
  • Site 16
  • Site 11
  • Site 66
  • Site 15
  • Site 29
  • Site 2
  • Site 67
  • Site 19
  • Site 56
  • Site 6
  • Site 40
  • Site102
  • Site 31
  • Site 60
  • Site 59
  • Site 38
  • Site 70
  • Site 85
  • Site 86
  • Site 101
  • Site 89
  • Site 111
  • Site 64
  • Site 113
  • Site 98
  • Site 33
  • Site 9
  • Site 92
  • Site 76
  • Site 83
  • Site 17
  • Site 23
  • Site 25
  • Site 30
  • Site 90
  • Site 10
  • Site 110
  • Site 14
  • Site 27
  • Site 48
  • Site 51
  • Site 71
  • Site 73
  • Site 43
  • Site 62
  • Site 80
  • Site 7
  • Site 44
  • Site 94
  • Site 47
  • Site 106
  • Site 41
  • Site 4
  • Site 52

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

EstroGel® Gel 0.9 grams 0.03%

EstroGel® Gel 1.25 grams 0.03%

Placebo Gel

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 8, 2005
Last Updated
September 8, 2022
Sponsor
ASCEND Therapeutics
Collaborators
Solvay Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00160173
Brief Title
Efficacy Study Comparing 0.9 g and 1.25 g Estrogel With Placebo for Vasomotor Symptoms and Vulvar and Vaginal Atrophy
Official Title
Efficacy Study Comparing 0.9 g and 1.25 g EstroGel® 0.03% Doses With Placebo in the Treatment of Vasomotor Symptoms and Vulvar and Vaginal Atrophy Associated With Menopause
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
December 2, 2004 (Actual)
Primary Completion Date
September 6, 2005 (Actual)
Study Completion Date
September 6, 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ASCEND Therapeutics
Collaborators
Solvay Pharmaceuticals

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postmenopausal Symptoms
Keywords
Post menopausal vasomotor symptoms

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
221 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EstroGel® Gel 0.9 grams 0.03%
Arm Type
Experimental
Arm Description
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.
Arm Title
EstroGel® Gel 1.25 grams 0.03%
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo Gel
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Estrogel
Intervention Type
Other
Intervention Name(s)
Placebo

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Director Solvay
Organizational Affiliation
Solvay Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Site 112
City
Birmingham
State/Province
Alabama
Country
United States
Facility Name
Site 74
City
Mobile
State/Province
Alabama
Country
United States
Facility Name
Site 20
City
Montgomery
State/Province
Alabama
Country
United States
Facility Name
Site 34
City
Tucson
State/Province
Arizona
Country
United States
Facility Name
Site 68
City
Tucson
State/Province
Arizona
Country
United States
Facility Name
Site 5
City
Jonesboro
State/Province
Arkansas
Country
United States
Facility Name
Site 88
City
Little Rock
State/Province
Arkansas
Country
United States
Facility Name
Site 95
City
Little Rock
State/Province
Arkansas
Country
United States
Facility Name
Site 104
City
Carmichael
State/Province
California
Country
United States
Facility Name
Site 42
City
Encinitas
State/Province
California
Country
United States
Facility Name
Site 21
City
San Diego
State/Province
California
Country
United States
Facility Name
Site 37
City
San Diego
State/Province
California
Country
United States
Facility Name
Site 78
City
San Diego
State/Province
California
Country
United States
Facility Name
Site 82
City
San Diego
State/Province
California
Country
United States
Facility Name
Site 69
City
Avon
State/Province
Connecticut
Country
United States
Facility Name
Site 58
City
Bridgeport
State/Province
Connecticut
Country
United States
Facility Name
Site 3
City
Groton
State/Province
Connecticut
Country
United States
Facility Name
Site 72
City
Hartford
State/Province
Connecticut
Country
United States
Facility Name
Site 54
City
New Britain
State/Province
Connecticut
Country
United States
Facility Name
Site 79
City
Southport
State/Province
Connecticut
Country
United States
Facility Name
Site 18
City
Waterbury
State/Province
Connecticut
Country
United States
Facility Name
Site 97
City
West Hartford
State/Province
Connecticut
Country
United States
Facility Name
Site 35
City
Aventura
State/Province
Florida
Country
United States
Facility Name
Site 36
City
Aventura
State/Province
Florida
Country
United States
Facility Name
Site 105
City
Clearwater
State/Province
Florida
Country
United States
Facility Name
Site 49
City
Clearwater
State/Province
Florida
Country
United States
Facility Name
Site 91
City
Daytona Beach
State/Province
Florida
Country
United States
Facility Name
Site 57
City
Melbourne
State/Province
Florida
Country
United States
Facility Name
Site 109
City
Miami
State/Province
Florida
Country
United States
Facility Name
Site 39
City
Pinellas Park
State/Province
Florida
Country
United States
Facility Name
Site 107
City
Spring Hill
State/Province
Florida
Country
United States
Facility Name
Site 100
City
Tampa
State/Province
Florida
Country
United States
Facility Name
Site 77
City
West Palm Beach
State/Province
Florida
Country
United States
Facility Name
Site 61
City
Alpharetta
State/Province
Georgia
Country
United States
Facility Name
Site 81
City
Alpharetta
State/Province
Georgia
Country
United States
Facility Name
Site 28
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
Site 93
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
Site 55
City
Decatur
State/Province
Georgia
Country
United States
Facility Name
Site 13
City
Douglasville
State/Province
Georgia
Country
United States
Facility Name
Site 87
City
Powder Springs
State/Province
Georgia
Country
United States
Facility Name
Site 22
City
Savannah
State/Province
Georgia
Country
United States
Facility Name
Site 99
City
Savannah
State/Province
Georgia
Country
United States
Facility Name
Site 53
City
Boise
State/Province
Idaho
Country
United States
Facility Name
Site 96
City
Champaign
State/Province
Illinois
Country
United States
Facility Name
Site 24
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
Site 84
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
Site 26
City
Peoria
State/Province
Illinois
Country
United States
Facility Name
Site 46
City
Peoria
State/Province
Illinois
Country
United States
Facility Name
Site 75
City
Evansville
State/Province
Indiana
Country
United States
Facility Name
Site 45
City
South Bend
State/Province
Indiana
Country
United States
Facility Name
Site 8
City
Waterloo
State/Province
Iowa
Country
United States
Facility Name
Site 108
City
Lexington
State/Province
Kentucky
Country
United States
Facility Name
Site 50
City
Baton Rouge
State/Province
Louisiana
Country
United States
Facility Name
Site 12
City
Metairie
State/Province
Louisiana
Country
United States
Facility Name
Site 65
City
New Orleans
State/Province
Louisiana
Country
United States
Facility Name
Site 16
City
Shreveport
State/Province
Louisiana
Country
United States
Facility Name
Site 11
City
Baltimore
State/Province
Maryland
Country
United States
Facility Name
Site 66
City
Ann Arbor
State/Province
Michigan
Country
United States
Facility Name
Site 15
City
Chaska
State/Province
Minnesota
Country
United States
Facility Name
Site 29
City
Creve Coeur
State/Province
Missouri
Country
United States
Facility Name
Site 2
City
Saint Louis
State/Province
Missouri
Country
United States
Facility Name
Site 67
City
Saint Louis
State/Province
Missouri
Country
United States
Facility Name
Site 19
City
Billings
State/Province
Montana
Country
United States
Facility Name
Site 56
City
Lincoln
State/Province
Nebraska
Country
United States
Facility Name
Site 6
City
Las Vegas
State/Province
Nevada
Country
United States
Facility Name
Site 40
City
Reno
State/Province
Nevada
Country
United States
Facility Name
Site102
City
Olean
State/Province
New York
Country
United States
Facility Name
Site 31
City
Fayetteville
State/Province
North Carolina
Country
United States
Facility Name
Site 60
City
New Bern
State/Province
North Carolina
Country
United States
Facility Name
Site 59
City
Raleigh
State/Province
North Carolina
Country
United States
Facility Name
Site 38
City
Winston-Salem
State/Province
North Carolina
Country
United States
Facility Name
Site 70
City
Winston-Salem
State/Province
North Carolina
Country
United States
Facility Name
Site 85
City
Winston-Salem
State/Province
North Carolina
Country
United States
Facility Name
Site 86
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
Site 101
City
Edmond
State/Province
Oklahoma
Country
United States
Facility Name
Site 89
City
Eugene
State/Province
Oregon
Country
United States
Facility Name
Site 111
City
Medford
State/Province
Oregon
Country
United States
Facility Name
Site 64
City
Portland
State/Province
Oregon
Country
United States
Facility Name
Site 113
City
Erie
State/Province
Pennsylvania
Country
United States
Facility Name
Site 98
City
Pottstown
State/Province
Pennsylvania
Country
United States
Facility Name
Site 33
City
Greenville
State/Province
South Carolina
Country
United States
Facility Name
Site 9
City
Chattanooga
State/Province
Tennessee
Country
United States
Facility Name
Site 92
City
Memphis
State/Province
Tennessee
Country
United States
Facility Name
Site 76
City
Nashville
State/Province
Tennessee
Country
United States
Facility Name
Site 83
City
Carrollton
State/Province
Texas
Country
United States
Facility Name
Site 17
City
Conroe
State/Province
Texas
Country
United States
Facility Name
Site 23
City
Corpus Christi
State/Province
Texas
Country
United States
Facility Name
Site 25
City
Corpus Christi
State/Province
Texas
Country
United States
Facility Name
Site 30
City
Dallas
State/Province
Texas
Country
United States
Facility Name
Site 90
City
Dallas
State/Province
Texas
Country
United States
Facility Name
Site 10
City
Houston
State/Province
Texas
Country
United States
Facility Name
Site 110
City
Houston
State/Province
Texas
Country
United States
Facility Name
Site 14
City
Houston
State/Province
Texas
Country
United States
Facility Name
Site 27
City
Houston
State/Province
Texas
Country
United States
Facility Name
Site 48
City
Houston
State/Province
Texas
Country
United States
Facility Name
Site 51
City
Houston
State/Province
Texas
Country
United States
Facility Name
Site 71
City
Houston
State/Province
Texas
Country
United States
Facility Name
Site 73
City
Houston
State/Province
Texas
Country
United States
Facility Name
Site 43
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
Site 62
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
Site 80
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
Site 7
City
Texarkana
State/Province
Texas
Country
United States
Facility Name
Site 44
City
Salt Lake City
State/Province
Utah
Country
United States
Facility Name
Site 94
City
Salt Lake City
State/Province
Utah
Country
United States
Facility Name
Site 47
City
Norfolk
State/Province
Virginia
Country
United States
Facility Name
Site 106
City
Richmond
State/Province
Virginia
Country
United States
Facility Name
Site 41
City
Richmond
State/Province
Virginia
Country
United States
Facility Name
Site 4
City
Seattle
State/Province
Washington
Country
United States
Facility Name
Site 52
City
Tacoma
State/Province
Washington
Country
United States

12. IPD Sharing Statement

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

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