Clinical trial NCT00141570: Study of the Efficacy of ESTRATEST® H.S. Tablets in Relieving Menopausal Symptoms in Estrogenized Postmenopausal Women
Official title: A Multi-Center, Double-Blind Study to Determine the Efficacy of ESTRATEST® H.S. Tablets in Relieving Menopausal Symptoms in Estrogenized Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Menopause
Keywords: Menopause; Postmenopause; Estrogen; Hormone Therapy
Lead sponsor: Solvay Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2005-09-01
Enrollment: 350
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine whether treatment with ESTRATEST® H.S. Tablets is superior to treatment with esterified estrogens tablets


Eligibility criteria: Inclusion Criteria:

Menopausal women between the ages of 30 and 65 years (inclusive) with symptoms of estrogen and/or androgen deficiency not currently controlled by estrogen therapy as determined by patient report and the Investigator's clinical judgement

Primary outcomes:
measure: Change from baseline in the total score of the Menopause Rating Scale (MRS) at Week 12
Secondary outcomes:
measure: Change from baseline in the MRS at Week 12 & monthly change from baseline to Week 12 in the MENQOL; Comparison of changes in SHBG & testosterone & how these changes correlate with the MRS
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Site 66
state: Alabama
city: Mobile
country: United States
facility: Site 57
state: Alabama
city: Montgomery
country: United States
facility: Site 46
state: Alabama
city: Phoenix
country: United States
facility: Site 29
state: Arizona
city: Tucson
country: United States
facility: Site 15
state: Arizona
city: Jonesboro
country: United States
facility: Site 3
state: Arkansas
city: Little Rock
country: United States
facility: Site 22
state: Arkansas
city: Carmichael
country: United States
facility: Site 68
state: California
city: Encinitas
country: United States
facility: Site 55
state: California
city: San Diego
country: United States
facility: Site 6
state: California
city: Santa Rosa
country: United States
facility: Site 45
state: California
city: Walnut Creek
country: United States
facility: Site 25
state: California
city: Denver
country: United States
facility: Site 26
state: Colorado
city: Groton
country: United States
facility: Site 1
state: Connecticut
city: Hartford
country: United States
facility: Site 54
state: Connecticut
city: Trumbull
country: United States
facility: Site 30
state: Connecticut
city: Waterbury
country: United States
facility: Site 34
state: Connecticut
city: Aventura
country: United States
facility: Site 10
state: Florida
city: Ft. Myers
country: United States
facility: Site 73
state: Florida
city: Leesburg
country: United States
facility: Site 51
state: Florida
city: Melbourne
country: United States
facility: Site 49
state: Florida
city: New Port Richey
country: United States
facility: Site 64
state: Florida
city: Ocala
country: United States
facility: Site 61
state: Florida
city: Palm Springs
country: United States
facility: Site 27
state: Florida
city: Pinellas Park
country: United States
facility: Site 11
state: Florida
city: Sarasota
country: United States
facility: Site 75
state: Florida
city: St. Petersburg
country: United States
facility: Site 69
state: Florida
city: Venice
country: United States
facility: Site 70
state: Florida
city: West Palm Beach
country: United States
facility: Site 17
state: Florida
city: Alpharetta
country: United States
facility: Site 50
state: Georgia
city: Atlanta
country: United States
facility: Site 5
state: Georgia
city: Decatur
country: United States
facility: Site 44
state: Georgia
city: Douglasville
country: United States
facility: Site 77
state: Georgia
city: Riverdale
country: United States
facility: Site 9
state: Georgia
city: Savannah
country: United States
facility: Site 7
state: Georgia
city: Boise
country: United States
facility: Site 47
state: Idaho
city: Champaign
country: United States
facility: Site 24
state: Illinois
city: Chicago
country: United States
facility: Site 20
state: Illinois
city: Peoria
country: United States
facility: Site 76
state: Illinois
city: Evansville
country: United States
facility: Site 58
state: Indiana
city: Wichita
country: United States
facility: Site 39
state: Kansas
city: Baton Rouge
country: United States
facility: Site 59
state: Louisiana
city: New Orleans
country: United States
facility: Site 52
state: Louisiana
city: Ann Arbor
country: United States
facility: Site 53
state: Michigan
city: Kansas City
country: United States
facility: Site 63
state: Missouri
city: Richmond Heights
country: United States
facility: Site 32
state: Missouri
city: St. Louis
country: United States
facility: Site 36
state: Missouri
city: Billings
country: United States
facility: Site 72
state: Montana
city: Lincoln
country: United States
facility: Site 21
state: Nebraska
city: Reno
country: United States
facility: Site 37
state: Nevada
city: Cary
country: United States
facility: Site 65
state: North Carolina
city: New Bern
country: United States
facility: Site 13
state: North Carolina
city: Winston-Salem
country: United States
facility: Site 16
state: North Carolina
city: Columbus
country: United States
facility: Site 60
state: Ohio
city: Oklahoma City
country: United States
facility: Site 67
state: Oklahoma
city: Tulsa
country: United States
facility: Site 40
state: Oklahoma
city: Eugene
country: United States
facility: Site 62
state: Oregon
city: Medford
country: United States
facility: Site 41
state: Oregon
city: Portland
country: United States
facility: Site 33
state: Oregon
city: Erie
country: United States
facility: Site 18
state: Pennsylvania
city: Philadelphia
country: United States
facility: Site 19
state: Pennsylvania
city: Pottstown
country: United States
facility: Site 23
state: Pennsylvania
city: Anderson
country: United States
facility: Site 31
state: South Carolina
city: Greer
country: United States
facility: Site 35
state: South Carolina
city: Chattanooga
country: United States
facility: Site 4
state: Tennessee
city: Conroe
country: United States
facility: Site 74
state: Texas
city: Corpus Christi
country: United States
facility: Site 8
state: Texas
city: Dallas
country: United States
facility: Site 71
state: Texas
city: Houston
country: United States
facility: Site 42
state: Texas
city: San Antonio
country: United States
facility: Site 14
state: Texas
city: Salt Lake City
country: United States
facility: Site 38
state: Utah
city: Norfolk
country: United States
facility: Site 28
state: Virginia
city: Richmond
country: United States
facility: Site 12
state: Virginia
city: Renton
country: United States
facility: Site 56
state: Washington
city: Seattle
country: United States
facility: Site 2
state: Washington
city: Spokane
country: United States
facility: Site 48
state: Washington
city: Tacoma
country: United States
facility: Site 43
state: Washington
Study officials:
affiliation: Solvay Pharmaceuticals
name: Global Clinical Director Solvay
role: STUDY_DIRECTOR
References: