Clinical trial NCT00160342: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hot Flushes, Menopause, Postmenopause
Keywords: Hormone replacement therapy, hot flushes, postmenopause
Lead sponsor: Solvay Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2005-09-12
Enrollment: 1251
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

1. Be able to communicate with the Investigator and study staff and be able to complete the required study procedures,
2. Be a female of any race between the ages of 45-65 years, in generally good health,
3. Be either naturally or surgically postmenopausal (with or without a uterus)

Exclusion Criteria:

1. Known sensitivity or contraindications to natural or synthetic estrogens, androgens or progestins,
2. 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

Primary outcomes:
measure: Mean change in frequency of moderate to severe vasomotor symptoms (VMS) from baseline to Week 4
timeFrame: 4 weeks
measure: Mean change in frequency of moderate to severe VMS from baseline to Week 12
timeFrame: 12 weeks
measure: Mean change in severity of moderate to severe VMS from baseline to Week 4
timeFrame: 4 weeks
measure: Mean change in severity of moderate to severe VMS from baseline to Week 12
timeFrame: 12 weeks
Secondary outcomes:
measure: Frequency and severity of moderate to severe and all hot flushes at each week
timeFrame: 12 weeks
measure: Mean change from baseline to Week 12 in the moderate to severe vulvar and vaginal atrophy symptom identified by the subject as most bothersome
timeFrame: 12 weeks
measure: Mean change from baseline to Week 12 in vaginal pH
timeFrame: 12 weeks
measure: Mean change from baseline to Week 12 in vaginal maturation index (parabasal and superficial cells)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Montgomery
country: United States
facility: Site 37
state: Alabama
city: Montgomery
country: United States
facility: Site 69
state: Alabama
city: Tucson
country: United States
facility: Site 44
state: Arizona
city: Jonesboro
country: United States
facility: Site 6
state: Arkansas
city: Little Rock
country: United States
facility: Site 62
state: Arkansas
city: Carmichael
country: United States
facility: Site 70
state: California
city: Carmichael
country: United States
facility: Site 85
state: California
city: Northridge
country: United States
facility: Site 87
state: California
city: San Diego
country: United States
facility: Site 18
state: California
city: San Diego
country: United States
facility: Site 27
state: California
city: San Diego
country: United States
facility: Site 54
state: California
city: Vista
country: United States
facility: Site 31
state: California
city: Walnut Creek
country: United States
facility: Site 68
state: California
city: Denver
country: United States
facility: Site 66
state: Colorado
city: Groton
country: United States
facility: Site 4
state: Connecticut
city: New Britain
country: United States
facility: Site 35
state: Connecticut
city: Waterbury
country: United States
facility: Site 14
state: Connecticut
city: Aventura
country: United States
facility: Site 25
state: Florida
city: Aventura
country: United States
facility: Site 26
state: Florida
city: Clearwater
country: United States
facility: Site 51
state: Florida
city: Clearwater
country: United States
facility: Site 71
state: Florida
city: Daytona Beach
country: United States
facility: Site 61
state: Florida
city: Gainesville
country: United States
facility: Site 75
state: Florida
city: Pensacola
country: United States
facility: Site 33
state: Florida
city: Stuart
country: United States
facility: Site 21
state: Florida
city: Tampa
country: United States
facility: Site 82
state: Florida
city: Venice
country: United States
facility: Site 9
state: Florida
city: West Palm Beach
country: United States
facility: Site 83
state: Florida
city: Alpharetta
country: United States
facility: Site 40
state: Georgia
city: Alpharetta
country: United States
facility: Site 90
state: Georgia
city: Atlanta
country: United States
facility: Site 23
state: Georgia
city: Atlanta
country: United States
facility: Site 8
state: Georgia
city: Powder Springs
country: United States
facility: Site 60
state: Georgia
city: Savannah
country: United States
facility: Site 55
state: Georgia
city: Boise
country: United States
facility: Site 76
state: Idaho
city: Champaign
country: United States
facility: Site 64
state: Illinois
city: Chicago
country: United States
facility: Site 58
state: Illinois
city: Chicago
country: United States
facility: Site 72
state: Illinois
city: Chicago
country: United States
facility: Site 74
state: Illinois
city: Evansville
country: United States
facility: Site 50
state: Indiana
city: Baton Rouge
country: United States
facility: Site 52
state: Louisiana
city: Mandeville
country: United States
facility: Site 65
state: Louisiana
city: Metarie
country: United States
facility: Site 73
state: Louisiana
city: Lutherville
country: United States
facility: Site 15
state: Maryland
city: Ann Arbor
country: United States
facility: Site 43
state: Michigan
city: Chaska
country: United States
facility: Site 12
state: Minnesota
city: Chesterfield
country: United States
facility: Site 80
state: Missouri
city: Kansas City
country: United States
facility: Site 16
state: Missouri
city: Kansas City
country: United States
facility: Site 19
state: Missouri
city: St. Louis
country: United States
facility: Site 3
state: Missouri
city: Billings
country: United States
facility: Site 17
state: Montana
city: Lincoln
country: United States
facility: Site 36
state: Nebraska
city: Las Vegas
country: United States
facility: Site 7
state: Nevada
city: Reno
country: United States
facility: Site 28
state: Nevada
city: New Bern
country: United States
facility: Site 39
state: North Carolina
city: Raleigh
country: United States
facility: Site 79
state: North Carolina
city: Winston Salem
country: United States
facility: Site 46
state: North Carolina
city: Winston Salem
country: United States
facility: Site 59
state: North Carolina
city: Cincinnati
country: United States
facility: Site 45
state: Ohio
city: Cincinnati
country: United States
facility: Site 81
state: Ohio
city: Columbus
country: United States
facility: Site 53
state: Ohio
city: Mayfield Heights
country: United States
facility: Site 34
state: Ohio
city: Mogadore
country: United States
facility: Site 78
state: Ohio
city: Tulsa
country: United States
facility: Site 77
state: Oklahoma
city: Portland
country: United States
facility: Site 13
state: Oregon
city: Portland
country: United States
facility: Site 89
state: Oregon
city: Philadelphia
country: United States
facility: Site 84
state: Pennsylvania
city: Pottstown
country: United States
facility: Site 63
state: Pennsylvania
city: Warwick
country: United States
facility: Site 22
state: Rhode Island
city: Greenville
country: United States
facility: Site 24
state: South Carolina
city: Hilton Head
country: United States
facility: Site 67
state: South Carolina
city: Chattanooga
country: United States
facility: Site 10
state: Tennessee
city: Memphis
country: United States
facility: Site 88
state: Tennessee
city: Nashville
country: United States
facility: Site 56
state: Tennessee
city: Bryan
country: United States
facility: Site 86
state: Texas
city: Corpus Christi
country: United States
facility: Site 20
state: Texas
city: Houston
country: United States
facility: Site 11
state: Texas
city: San Antonio
country: United States
facility: Site 30
state: Texas
city: San Antonio
country: United States
facility: Site 41
state: Texas
city: Salt Lake City
country: United States
facility: Site 49
state: Utah
city: Charlottesville
country: United States
facility: Site 47
state: Virginia
city: Norfolk
country: United States
facility: Site 2
state: Virginia
city: Richmond
country: United States
facility: Site 29
state: Virginia
city: Richmond
country: United States
facility: Site 48
state: Virginia
city: Virginia Beach
country: United States
facility: Site 42
state: Virginia
city: Seattle
country: United States
facility: Site 5
state: Washington
city: Spokane
country: United States
facility: Site 38
state: Washington
city: Tacoma
country: United States
facility: Site 32
state: Washington
city: Abbotsford
country: Canada
facility: Site 120
state: British Columbia
city: North Vancouver
country: Canada
facility: Site 100
state: British Columbia
city: Victoria
country: Canada
facility: Site 135
state: British Columbia
city: West Vancouver
country: Canada
facility: Site 116
state: British Columbia
city: Winnipeg
country: Canada
facility: Site 122
state: Manitoba
city: Winnipeg
country: Canada
facility: Site 93
state: Manitoba
city: St. John's
country: Canada
facility: Site 111
state: Newfoundland and Labrador
city: Burlington
country: Canada
facility: Site 109
state: Ontario
city: Corunna
country: Canada
facility: Site 114
state: Ontario
city: Hamilton
country: Canada
facility: Site 95
state: Ontario
city: Kingston
country: Canada
facility: Site 115
state: Ontario
city: London
country: Canada
facility: Site 107
state: Ontario
city: Newmarket
country: Canada
facility: Site 106
state: Ontario
city: Ottawa
country: Canada
facility: Site 137
state: Ontario
city: Peterborough
country: Canada
facility: Site 117
state: Ontario
city: Sarnia
country: Canada
facility: Site 113
state: Ontario
city: Sarnia
country: Canada
facility: Site 92
state: Ontario
city: Strathroy
country: Canada
facility: Site 96
state: Ontario
city: Montreal
country: Canada
facility: Site 112
state: Quebec
city: Rimouski
country: Canada
facility: Site 103
state: Quebec
city: Sainte Foy
country: Canada
facility: Site 119
state: Quebec
city: Sainte Foy
country: Canada
facility: Site 94
state: Quebec
city: Shawinigan
country: Canada
facility: Site 91
state: Quebec
city: Sherbrooke
country: Canada
facility: Site 105
state: Quebec
city: Sherbrooke
country: Canada
facility: Site 136
state: Quebec
city: Moscow
country: Russian Federation
facility: Site 124
city: Moscow
country: Russian Federation
facility: Site 125
city: Moscow
country: Russian Federation
facility: Site 126
city: Moscow
country: Russian Federation
facility: Site 128
city: Moscow
country: Russian Federation
facility: Site 129
city: Moscow
country: Russian Federation
facility: Site 130
city: Moscow
country: Russian Federation
facility: Site 132
city: Moscow
country: Russian Federation
facility: Site 133
city: St. Petersburg
country: Russian Federation
facility: Site 127
city: St. Petersburg
country: Russian Federation
facility: Site 131
city: St. Petersburg
country: Russian Federation
facility: Site 134
city: St. Petersburg
country: Russian Federation
facility: Site 138
Study officials:
affiliation: Solvay Pharmaceuticals
name: Global Clinical Director Solvay
role: STUDY_DIRECTOR
References: