search
Back to results

Comparison of Estrogen and Methyltestosterone Combination Treatments for Postmenopausal Hot Flushes

Primary Purpose

Hot Flushes, Menopause, Postmenopause

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Esterified Estrogens (EE) and Methyltestosterone (MT)
Esterified Estrogens (EE) and Methyltestosterone (MT)
Esterified Estrogens (EE) and Methyltestosterone (MT)
Esterified Estrogens (EE) and Methyltestosterone (MT)
Esterified Estrogens (EE) and Methyltestosterone (MT)
Esterified Estrogens (EE) and Methyltestosterone (MT)
Esterified Estrogens (EE) and Methyltestosterone (MT)
Esterified Estrogens (EE) and Methyltestosterone (MT)
Esterified Estrogens (EE) and Methyltestosterone (MT)
Sponsored by
Solvay Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hot Flushes, Menopause, Postmenopause focused on measuring Hormone replacement therapy, hot flushes, postmenopause

Eligibility Criteria

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

Inclusion Criteria: Be able to communicate with the Investigator and study staff and be able to complete the required study procedures, Be a female of any race between the ages of 45-65 years, in generally good health, Be either naturally or surgically postmenopausal (with or without a uterus) Exclusion Criteria: Known sensitivity or contraindications to natural or synthetic estrogens, androgens or progestins, History of or current diagnosis of malignant melanoma, breast cancer or any cancer (except non-melanomatous skin cancer) diagnosed less than 5 years prior to beginning the study

Sites / Locations

  • Site 37
  • Site 69
  • Site 44
  • Site 6
  • Site 62
  • Site 70
  • Site 85
  • Site 87
  • Site 18
  • Site 27
  • Site 54
  • Site 31
  • Site 68
  • Site 66
  • Site 4
  • Site 35
  • Site 14
  • Site 25
  • Site 26
  • Site 51
  • Site 71
  • Site 61
  • Site 75
  • Site 33
  • Site 21
  • Site 82
  • Site 9
  • Site 83
  • Site 40
  • Site 90
  • Site 23
  • Site 8
  • Site 60
  • Site 55
  • Site 76
  • Site 64
  • Site 58
  • Site 72
  • Site 74
  • Site 50
  • Site 52
  • Site 65
  • Site 73
  • Site 15
  • Site 43
  • Site 12
  • Site 80
  • Site 16
  • Site 19
  • Site 3
  • Site 17
  • Site 36
  • Site 7
  • Site 28
  • Site 39
  • Site 79
  • Site 46
  • Site 59
  • Site 45
  • Site 81
  • Site 53
  • Site 34
  • Site 78
  • Site 77
  • Site 13
  • Site 89
  • Site 84
  • Site 63
  • Site 22
  • Site 24
  • Site 67
  • Site 10
  • Site 88
  • Site 56
  • Site 86
  • Site 20
  • Site 11
  • Site 30
  • Site 41
  • Site 49
  • Site 47
  • Site 2
  • Site 29
  • Site 48
  • Site 42
  • Site 5
  • Site 38
  • Site 32
  • Site 120
  • Site 100
  • Site 135
  • Site 116
  • Site 122
  • Site 93
  • Site 111
  • Site 109
  • Site 114
  • Site 95
  • Site 115
  • Site 107
  • Site 106
  • Site 137
  • Site 117
  • Site 113
  • Site 92
  • Site 96
  • Site 112
  • Site 103
  • Site 119
  • Site 94
  • Site 91
  • Site 105
  • Site 136
  • Site 124
  • Site 125
  • Site 126
  • Site 128
  • Site 129
  • Site 130
  • Site 132
  • Site 133
  • Site 127
  • Site 131
  • Site 134
  • Site 138

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm Type

Active Comparator

Experimental

Experimental

Active Comparator

Experimental

Experimental

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

1

2

3

4

5

6

7

8

9

Arm Description

Outcomes

Primary Outcome Measures

Mean change in frequency of moderate to severe vasomotor symptoms (VMS) from baseline to Week 4
Mean change in frequency of moderate to severe VMS from baseline to Week 12
Mean change in severity of moderate to severe VMS from baseline to Week 4
Mean change in severity of moderate to severe VMS from baseline to Week 12

Secondary Outcome Measures

Frequency and severity of moderate to severe and all hot flushes at each week
Mean change from baseline to Week 12 in the moderate to severe vulvar and vaginal atrophy symptom identified by the subject as most bothersome
Mean change from baseline to Week 12 in vaginal pH
Mean change from baseline to Week 12 in vaginal maturation index (parabasal and superficial cells)

Full Information

First Posted
September 9, 2005
Last Updated
August 14, 2008
Sponsor
Solvay Pharmaceuticals
search

1. Study Identification

Unique Protocol Identification Number
NCT00160342
Brief Title
Comparison of Estrogen and Methyltestosterone Combination Treatments for Postmenopausal Hot Flushes
Official Title
A Multi-Center, Double-Blind, Placebo-Controlled Comparison of Multiple Doses of Esterified Estrogens and Methyltestosterone, in Combination and Alone, in Relieving Vasomotor Symptoms in Postmenopausal Women
Study Type
Interventional

2. Study Status

Record Verification Date
August 2008
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
September 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Solvay Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a research study to evaluate the effectiveness, safety and side effects of several dose levels of esterified estrogens (EE) and methyltestosterone (MT) given individually and in combination compared to a placebo (a tablet with no active drug in it) as a possible treatment for vasomotor symptoms (such as hot flushes and flushing) of menopause. EE and testosterone are two hormones which are typically deficient in menopausal women

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hot Flushes, Menopause, Postmenopause
Keywords
Hormone replacement therapy, hot flushes, postmenopause

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1251 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Title
2
Arm Type
Experimental
Arm Title
3
Arm Type
Experimental
Arm Title
4
Arm Type
Active Comparator
Arm Title
5
Arm Type
Experimental
Arm Title
6
Arm Type
Experimental
Arm Title
7
Arm Type
Active Comparator
Arm Title
8
Arm Type
Active Comparator
Arm Title
9
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Esterified Estrogens (EE) and Methyltestosterone (MT)
Intervention Description
oral tablet, QD, 12 weeks, 0.15 EE/0.15 MT
Intervention Type
Drug
Intervention Name(s)
Esterified Estrogens (EE) and Methyltestosterone (MT)
Intervention Description
oral tablet, QD, 12 weeks, 0.15 EE/0.15 MT
Intervention Type
Drug
Intervention Name(s)
Esterified Estrogens (EE) and Methyltestosterone (MT)
Intervention Description
oral tablet, QD, 12 weeks, 0.15 EE/0.30 MT
Intervention Type
Drug
Intervention Name(s)
Esterified Estrogens (EE) and Methyltestosterone (MT)
Intervention Description
oral tablet, QD, 12 weeks, 0.30 EE/0.30 MT
Intervention Type
Drug
Intervention Name(s)
Esterified Estrogens (EE) and Methyltestosterone (MT)
Intervention Description
oral tablet, QD, 12 weeks, 0.30 EE
Intervention Type
Drug
Intervention Name(s)
Esterified Estrogens (EE) and Methyltestosterone (MT)
Intervention Description
oral tablet, QD, 12 weeks, 0.30 EE/0.60 MT
Intervention Type
Drug
Intervention Name(s)
Esterified Estrogens (EE) and Methyltestosterone (MT)
Intervention Description
oral tablet, QD, 12 weeks, 0.45 EE
Intervention Type
Drug
Intervention Name(s)
Esterified Estrogens (EE) and Methyltestosterone (MT)
Intervention Description
oral tablet, QD, 12 weeks, 0.60 MT
Intervention Type
Drug
Intervention Name(s)
Esterified Estrogens (EE) and Methyltestosterone (MT)
Intervention Description
oral tablet, QD, 12 weeks, Placebo
Primary Outcome Measure Information:
Title
Mean change in frequency of moderate to severe vasomotor symptoms (VMS) from baseline to Week 4
Time Frame
4 weeks
Title
Mean change in frequency of moderate to severe VMS from baseline to Week 12
Time Frame
12 weeks
Title
Mean change in severity of moderate to severe VMS from baseline to Week 4
Time Frame
4 weeks
Title
Mean change in severity of moderate to severe VMS from baseline to Week 12
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Frequency and severity of moderate to severe and all hot flushes at each week
Time Frame
12 weeks
Title
Mean change from baseline to Week 12 in the moderate to severe vulvar and vaginal atrophy symptom identified by the subject as most bothersome
Time Frame
12 weeks
Title
Mean change from baseline to Week 12 in vaginal pH
Time Frame
12 weeks
Title
Mean change from baseline to Week 12 in vaginal maturation index (parabasal and superficial cells)
Time Frame
12 weeks

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: Be able to communicate with the Investigator and study staff and be able to complete the required study procedures, Be a female of any race between the ages of 45-65 years, in generally good health, Be either naturally or surgically postmenopausal (with or without a uterus) Exclusion Criteria: Known sensitivity or contraindications to natural or synthetic estrogens, androgens or progestins, History of or current diagnosis of malignant melanoma, breast cancer or any cancer (except non-melanomatous skin cancer) diagnosed less than 5 years prior to beginning the study
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 37
City
Montgomery
State/Province
Alabama
Country
United States
Facility Name
Site 69
City
Montgomery
State/Province
Alabama
Country
United States
Facility Name
Site 44
City
Tucson
State/Province
Arizona
Country
United States
Facility Name
Site 6
City
Jonesboro
State/Province
Arkansas
Country
United States
Facility Name
Site 62
City
Little Rock
State/Province
Arkansas
Country
United States
Facility Name
Site 70
City
Carmichael
State/Province
California
Country
United States
Facility Name
Site 85
City
Carmichael
State/Province
California
Country
United States
Facility Name
Site 87
City
Northridge
State/Province
California
Country
United States
Facility Name
Site 18
City
San Diego
State/Province
California
Country
United States
Facility Name
Site 27
City
San Diego
State/Province
California
Country
United States
Facility Name
Site 54
City
San Diego
State/Province
California
Country
United States
Facility Name
Site 31
City
Vista
State/Province
California
Country
United States
Facility Name
Site 68
City
Walnut Creek
State/Province
California
Country
United States
Facility Name
Site 66
City
Denver
State/Province
Colorado
Country
United States
Facility Name
Site 4
City
Groton
State/Province
Connecticut
Country
United States
Facility Name
Site 35
City
New Britain
State/Province
Connecticut
Country
United States
Facility Name
Site 14
City
Waterbury
State/Province
Connecticut
Country
United States
Facility Name
Site 25
City
Aventura
State/Province
Florida
Country
United States
Facility Name
Site 26
City
Aventura
State/Province
Florida
Country
United States
Facility Name
Site 51
City
Clearwater
State/Province
Florida
Country
United States
Facility Name
Site 71
City
Clearwater
State/Province
Florida
Country
United States
Facility Name
Site 61
City
Daytona Beach
State/Province
Florida
Country
United States
Facility Name
Site 75
City
Gainesville
State/Province
Florida
Country
United States
Facility Name
Site 33
City
Pensacola
State/Province
Florida
Country
United States
Facility Name
Site 21
City
Stuart
State/Province
Florida
Country
United States
Facility Name
Site 82
City
Tampa
State/Province
Florida
Country
United States
Facility Name
Site 9
City
Venice
State/Province
Florida
Country
United States
Facility Name
Site 83
City
West Palm Beach
State/Province
Florida
Country
United States
Facility Name
Site 40
City
Alpharetta
State/Province
Georgia
Country
United States
Facility Name
Site 90
City
Alpharetta
State/Province
Georgia
Country
United States
Facility Name
Site 23
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
Site 8
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
Site 60
City
Powder Springs
State/Province
Georgia
Country
United States
Facility Name
Site 55
City
Savannah
State/Province
Georgia
Country
United States
Facility Name
Site 76
City
Boise
State/Province
Idaho
Country
United States
Facility Name
Site 64
City
Champaign
State/Province
Illinois
Country
United States
Facility Name
Site 58
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
Site 72
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
Site 74
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
Site 50
City
Evansville
State/Province
Indiana
Country
United States
Facility Name
Site 52
City
Baton Rouge
State/Province
Louisiana
Country
United States
Facility Name
Site 65
City
Mandeville
State/Province
Louisiana
Country
United States
Facility Name
Site 73
City
Metarie
State/Province
Louisiana
Country
United States
Facility Name
Site 15
City
Lutherville
State/Province
Maryland
Country
United States
Facility Name
Site 43
City
Ann Arbor
State/Province
Michigan
Country
United States
Facility Name
Site 12
City
Chaska
State/Province
Minnesota
Country
United States
Facility Name
Site 80
City
Chesterfield
State/Province
Missouri
Country
United States
Facility Name
Site 16
City
Kansas City
State/Province
Missouri
Country
United States
Facility Name
Site 19
City
Kansas City
State/Province
Missouri
Country
United States
Facility Name
Site 3
City
St. Louis
State/Province
Missouri
Country
United States
Facility Name
Site 17
City
Billings
State/Province
Montana
Country
United States
Facility Name
Site 36
City
Lincoln
State/Province
Nebraska
Country
United States
Facility Name
Site 7
City
Las Vegas
State/Province
Nevada
Country
United States
Facility Name
Site 28
City
Reno
State/Province
Nevada
Country
United States
Facility Name
Site 39
City
New Bern
State/Province
North Carolina
Country
United States
Facility Name
Site 79
City
Raleigh
State/Province
North Carolina
Country
United States
Facility Name
Site 46
City
Winston Salem
State/Province
North Carolina
Country
United States
Facility Name
Site 59
City
Winston Salem
State/Province
North Carolina
Country
United States
Facility Name
Site 45
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
Site 81
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
Site 53
City
Columbus
State/Province
Ohio
Country
United States
Facility Name
Site 34
City
Mayfield Heights
State/Province
Ohio
Country
United States
Facility Name
Site 78
City
Mogadore
State/Province
Ohio
Country
United States
Facility Name
Site 77
City
Tulsa
State/Province
Oklahoma
Country
United States
Facility Name
Site 13
City
Portland
State/Province
Oregon
Country
United States
Facility Name
Site 89
City
Portland
State/Province
Oregon
Country
United States
Facility Name
Site 84
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
Site 63
City
Pottstown
State/Province
Pennsylvania
Country
United States
Facility Name
Site 22
City
Warwick
State/Province
Rhode Island
Country
United States
Facility Name
Site 24
City
Greenville
State/Province
South Carolina
Country
United States
Facility Name
Site 67
City
Hilton Head
State/Province
South Carolina
Country
United States
Facility Name
Site 10
City
Chattanooga
State/Province
Tennessee
Country
United States
Facility Name
Site 88
City
Memphis
State/Province
Tennessee
Country
United States
Facility Name
Site 56
City
Nashville
State/Province
Tennessee
Country
United States
Facility Name
Site 86
City
Bryan
State/Province
Texas
Country
United States
Facility Name
Site 20
City
Corpus Christi
State/Province
Texas
Country
United States
Facility Name
Site 11
City
Houston
State/Province
Texas
Country
United States
Facility Name
Site 30
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
Site 41
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
Site 49
City
Salt Lake City
State/Province
Utah
Country
United States
Facility Name
Site 47
City
Charlottesville
State/Province
Virginia
Country
United States
Facility Name
Site 2
City
Norfolk
State/Province
Virginia
Country
United States
Facility Name
Site 29
City
Richmond
State/Province
Virginia
Country
United States
Facility Name
Site 48
City
Richmond
State/Province
Virginia
Country
United States
Facility Name
Site 42
City
Virginia Beach
State/Province
Virginia
Country
United States
Facility Name
Site 5
City
Seattle
State/Province
Washington
Country
United States
Facility Name
Site 38
City
Spokane
State/Province
Washington
Country
United States
Facility Name
Site 32
City
Tacoma
State/Province
Washington
Country
United States
Facility Name
Site 120
City
Abbotsford
State/Province
British Columbia
Country
Canada
Facility Name
Site 100
City
North Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
Site 135
City
Victoria
State/Province
British Columbia
Country
Canada
Facility Name
Site 116
City
West Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
Site 122
City
Winnipeg
State/Province
Manitoba
Country
Canada
Facility Name
Site 93
City
Winnipeg
State/Province
Manitoba
Country
Canada
Facility Name
Site 111
City
St. John's
State/Province
Newfoundland and Labrador
Country
Canada
Facility Name
Site 109
City
Burlington
State/Province
Ontario
Country
Canada
Facility Name
Site 114
City
Corunna
State/Province
Ontario
Country
Canada
Facility Name
Site 95
City
Hamilton
State/Province
Ontario
Country
Canada
Facility Name
Site 115
City
Kingston
State/Province
Ontario
Country
Canada
Facility Name
Site 107
City
London
State/Province
Ontario
Country
Canada
Facility Name
Site 106
City
Newmarket
State/Province
Ontario
Country
Canada
Facility Name
Site 137
City
Ottawa
State/Province
Ontario
Country
Canada
Facility Name
Site 117
City
Peterborough
State/Province
Ontario
Country
Canada
Facility Name
Site 113
City
Sarnia
State/Province
Ontario
Country
Canada
Facility Name
Site 92
City
Sarnia
State/Province
Ontario
Country
Canada
Facility Name
Site 96
City
Strathroy
State/Province
Ontario
Country
Canada
Facility Name
Site 112
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Site 103
City
Rimouski
State/Province
Quebec
Country
Canada
Facility Name
Site 119
City
Sainte Foy
State/Province
Quebec
Country
Canada
Facility Name
Site 94
City
Sainte Foy
State/Province
Quebec
Country
Canada
Facility Name
Site 91
City
Shawinigan
State/Province
Quebec
Country
Canada
Facility Name
Site 105
City
Sherbrooke
State/Province
Quebec
Country
Canada
Facility Name
Site 136
City
Sherbrooke
State/Province
Quebec
Country
Canada
Facility Name
Site 124
City
Moscow
Country
Russian Federation
Facility Name
Site 125
City
Moscow
Country
Russian Federation
Facility Name
Site 126
City
Moscow
Country
Russian Federation
Facility Name
Site 128
City
Moscow
Country
Russian Federation
Facility Name
Site 129
City
Moscow
Country
Russian Federation
Facility Name
Site 130
City
Moscow
Country
Russian Federation
Facility Name
Site 132
City
Moscow
Country
Russian Federation
Facility Name
Site 133
City
Moscow
Country
Russian Federation
Facility Name
Site 127
City
St. Petersburg
Country
Russian Federation
Facility Name
Site 131
City
St. Petersburg
Country
Russian Federation
Facility Name
Site 134
City
St. Petersburg
Country
Russian Federation
Facility Name
Site 138
City
St. Petersburg
Country
Russian Federation

12. IPD Sharing Statement

Learn more about this trial

Comparison of Estrogen and Methyltestosterone Combination Treatments for Postmenopausal Hot Flushes

We'll reach out to this number within 24 hrs