Clinical trial NCT00446199: Low-dose Hormone Therapy for Relief of Vasomotor Symptoms
Official title: A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Determine the Lowest Effective Dose of Combinations of Oral Drospirenone and 17 Beta-Estradiol for the Relief of Moderate to Severe Vasomotor Symptoms in Postmenopausal Women Over a Treatment Period of 12 Weeks
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Vasomotor Symptoms
Hot Flashes
Keywords: Vasomotor symptom relief
Postmenopausal women
Severe to Moderate Vasomotor symptoms
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2007-03-12
Enrollment: 735
Sex: FEMALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the lowest effective dose of the study drug for the relief of moderate to severe vasomotor symptoms in postmenopausal women for 12 weeks.

Detailed description: This study has previously been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc.

Bayer HealthCare Pharmaceuticals, Inc. is the sponsor of the trial.

Eligibility criteria: Inclusion Criteria:

- Postmenopausal women \>40 years of age experiencing a minimum of 7 to 8 moderate to severe hot flushes per day or 50 to 60 moderate to severe hot flushes per week

Exclusion Criteria:

* The usual exclusion criteria for hormone therapy apply
* Intake of medications other than hormones affecting hot flushes

Primary outcomes:
measure: Change From Baseline to Week 12 in Weekly Frequency of Moderate to Severe Hot Flushes (Median Value)
timeFrame: Baseline until 12 weeks of treatment
measure: Change From Baseline to Week 4 in Weekly Frequency of Moderate to Severe Hot Flushes (Median Value)
timeFrame: Baseline until 4 weeks of treatment
measure: Change From Baseline to Week 12 in Weekly Mean Daily Severity of Moderate to Severe Hot Flushes (Median Value)
timeFrame: Baseline until 12 weeks of treatment
measure: Change From Baseline to Week 4 in Weekly Mean Daily Severity of Moderate to Severe Hot Flushes (Median Value)
timeFrame: Baseline until 4 weeks of treatment
Secondary outcomes:
measure: Change From Baseline to Week 12 in Vaginal pH
timeFrame: Baseline until 12 weeks of treatment
measure: Change From Baseline to Week 12 in Vaginal Maturation Value
timeFrame: Baseline until 12 weeks of treatment
measure: Symptoms of Vulvar and Vaginal Atrophy: Severity of Symptom 'Vaginal Dryness'
timeFrame: After 12 weeks of treatment
measure: Symptoms of Vulvar and Vaginal Atrophy: Severity of Symptom 'Vaginal and/or Vulvar Irritation/Itching'
timeFrame: After 12 weeks of treatment
measure: Symptoms of Vulvar and Vaginal Atrophy: Severity of Symptom 'Dysuria'
timeFrame: After 12 weeks of treatment
measure: Symptoms of Vulvar and Vaginal Atrophy: Severity of Symptom 'Vaginal Pain Associated With Sexual Activity'
timeFrame: After 12 weeks of treatment
measure: Symptoms of Vulvar and Vaginal Atrophy: Severity of Symptom 'Vaginal Bleeding Associated With Sexual Activity'
timeFrame: After 12 weeks of treatment
measure: Urogenital Symptoms: Number of Participants With Symptom 'Frequent Urination'
timeFrame: After 12 weeks of treatment
measure: Urogenital Symptoms: Number of Participants With Symptom 'Involuntary Urination When Laughing or Coughing'
timeFrame: After 12 weeks of treatment
measure: Urogenital Symptoms: Number of Participants With Symptom 'Urination at Night'
timeFrame: After 12 weeks of treatment
Other outcomes:
measure: Change From Baseline to Week 12 in Weekly Frequency of Moderate to Severe Hot Flushes (Mean Value)
timeFrame: Baseline until 12 weeks of treatment
measure: Change From Baseline to Week 4 in Weekly Frequency of Moderate to Severe Hot Flushes (Mean Value)
timeFrame: Baseline until 4 weeks of treatment
measure: Change From Baseline to Week 12 in Weekly Mean Daily Severity of Moderate to Severe Hot Flushes (Mean Value)
timeFrame: Baseline until 12 weeks of treatment
measure: Change From Baseline to Week 4 in Weekly Mean Daily Severity of Moderate to Severe Hot Flushes (Mean Value)
timeFrame: Baseline until 4 weeks of treatment
Locations:
city: Mobile
country: United States
state: Alabama
city: Chandler
country: United States
state: Arizona
city: Phoenix
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Little Rock
country: United States
state: Arkansas
city: Paramount
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Diego
country: United States
state: California
city: Valley Village
country: United States
state: California
city: Vista
country: United States
state: California
city: Colorado Springs
country: United States
state: Colorado
city: Denver
country: United States
state: Colorado
city: New Britain
country: United States
state: Connecticut
city: Boynton Beach
country: United States
state: Florida
city: Clearwater
country: United States
state: Florida
city: Daytona Beach
country: United States
state: Florida
city: Fort Myers
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Lake Worth
country: United States
state: Florida
city: Leesburg
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: New Port Richey
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: West Palm Beach
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Atlanta
country: United States
state: Georgia
city: Decatur
country: United States
state: Georgia
city: Boise
country: United States
state: Idaho
city: Idaho Falls
country: United States
state: Idaho
city: Arlington Heights
country: United States
state: Illinois
city: Champaign
country: United States
state: Illinois
city: La Grange Park
country: United States
state: Illinois
city: Newburgh
country: United States
state: Indiana
city: Lexington
country: United States
state: Kentucky
city: Amite
country: United States
state: Louisiana
city: Marrero
country: United States
state: Louisiana
city: Paw Paw
country: United States
state: Michigan
city: Chaska
country: United States
state: Minnesota
city: Springfield
country: United States
state: Missouri
city: Billings
country: United States
state: Montana
city: Billings
country: United States
state: Montana
city: Lincoln
country: United States
state: Nebraska
city: Las Vegas
country: United States
state: Nevada
city: Reno
country: United States
state: Nevada
city: Lawrenceville
country: United States
state: New Jersey
city: New Brunswick
country: United States
state: New Jersey
city: Princeton
country: United States
state: New Jersey
city: Albuquerque
country: United States
state: New Mexico
city: Raleigh
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Fargo
country: United States
state: North Dakota
city: Cleveland
country: United States
state: Ohio
city: Columbus
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Tulsa
country: United States
state: Oklahoma
city: Erie
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Wexford
country: United States
state: Pennsylvania
city: Columbia
country: United States
state: South Carolina
city: Sioux Falls
country: United States
state: South Dakota
city: Chattanooga
country: United States
state: Tennessee
city: Chattanooga
country: United States
state: Tennessee
city: Memphis
country: United States
state: Tennessee
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Burlington
country: United States
state: Vermont
city: Norfolk
country: United States
state: Virginia
city: Richmond
country: United States
state: Virginia
city: Renton
country: United States
state: Washington
city: Seattle
country: United States
state: Washington
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: Sutter G, Schmelter T, Gude K, Schaefers M, Gerlinger C, Archer DF. Population pharmacokinetic/pharmacodynamic evaluation of low-dose drospirenone with 17beta-estradiol in postmenopausal women with moderate to severe vasomotor symptoms. Menopause. 2014 Mar;21(3):236-42. doi: 10.1097/GME.0b013e31829c12e8.
citation: Archer DF, Schmelter T, Schaefers M, Gerlinger C, Gude K. A randomized, double-blind, placebo-controlled study of the lowest effective dose of drospirenone with 17beta-estradiol for moderate to severe vasomotor symptoms in postmenopausal women. Menopause. 2014 Mar;21(3):227-35. doi: 10.1097/GME.0b013e31829c1431.
citation: K. Gude; T. Schmelter; M. Schaefers; C. Gerlinger. Efficacy of low dose Angeliq (0.5 mg E2 and 0.25 or 0.5 mg DRSP) compared to Angeliq (1 mg E2 and 1, 2 or 3 mg DRSP) in postmenopausal women with moderate to severe hot flushes. Menopause, Vol. 19, No. 12, 2012 * 2012, P-36, p 1388
citation: Gerlinger C, Gude K, Hiemeyer F, Schmelter T, Schafers M. An empirically validated responder definition for the reduction of moderate to severe hot flushes in postmenopausal women. Menopause. 2012 Jul;19(7):799-803. doi: 10.1097/gme.0b013e31823de8ba.