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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
735
One tablet \[0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)\] per day taken orally for 3 cycles (28 days per cycle).
One tablet \[0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)\] per day taken orally for 3 cycles (28 days per cycle).
One tablet \[17β-estradiol (E2 0.3mg)\] per day taken orally for 3 cycles (28 days per cycle).
Change From Baseline to Week 12 in Weekly Frequency of Moderate to Severe Hot Flushes (Median Value)
Subjects record daily on the diary cards the frequency and severity of hot flushes during the treatment period as none, mild, moderate or severe. Absolute change calculated as week 12 number of moderate to severe hot flushes minus baseline number.
Time frame: Baseline until 12 weeks of treatment
Change From Baseline to Week 4 in Weekly Frequency of Moderate to Severe Hot Flushes (Median Value)
Subjects record daily on the diary cards the frequency and severity of hot flushes during the treatment period as none, mild, moderate or severe. Absolute change calculated as week 4 number of moderate to severe hot flushes minus baseline number.
Time frame: Baseline until 4 weeks of treatment
Change From Baseline to Week 12 in Weekly Mean Daily Severity of Moderate to Severe Hot Flushes (Median Value)
Subjects record daily on the diary cards the frequency and severity of hot flushes during the treatment period as none, mild, moderate or severe. Daily score is calculated as \[(2 x number of moderate hot flushes) + (3 x number of severe hot flushes)\] / (total number of moderate to severe hot flushes on that day). Range = 0 (lowest severity) to 3 (highest severity). Absolute change calculated as week 12 severity of moderate to severe hot flushes minus baseline severity.
Time frame: Baseline until 12 weeks of treatment
Change From Baseline to Week 4 in Weekly Mean Daily Severity of Moderate to Severe Hot Flushes (Median Value)
Subjects record daily on the diary cards the frequency and severity of hot flushes during the treatment period as none, mild, moderate or severe. Daily score is calculated as \[(2 x number of moderate hot flushes) + (3 x number of severe hot flushes)\] / (total number of moderate to severe hot flushes on that day). Range = 0 (lowest severity) to 3 (highest severity). Absolute change calculated as week 4 severity of moderate to severe hot flushes minus baseline severity.
Time frame: Baseline until 4 weeks of treatment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Matching placebo tablet per day taken orally for 3 cycles (28 days per cycle).
Unnamed facility
Mobile, Alabama, United States
Unnamed facility
Chandler, Arizona, United States
Unnamed facility
Phoenix, Arizona, United States
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Tucson, Arizona, United States
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Tucson, Arizona, United States
Unnamed facility
Little Rock, Arkansas, United States
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Paramount, California, United States
Unnamed facility
San Diego, California, United States
Unnamed facility
San Diego, California, United States
Unnamed facility
San Diego, California, United States
...and 66 more locations
Change From Baseline to Week 12 in Vaginal pH
Vaginal pH determined following speculum examination using vaginal pH paper and recorded on case report form (CRF). Absolute change calculated as week 12 pH minus baseline pH.
Time frame: Baseline until 12 weeks of treatment
Change From Baseline to Week 12 in Vaginal Maturation Value
Calculated as (percentage of superficial cells) + 0.5 \* (percentage of intermediate cells). Absolute change calculated as week 12 value minus baseline value.
Time frame: Baseline until 12 weeks of treatment
Symptoms of Vulvar and Vaginal Atrophy: Severity of Symptom 'Vaginal Dryness'
Subjects self-assessed symptom severity
Time frame: After 12 weeks of treatment
Symptoms of Vulvar and Vaginal Atrophy: Severity of Symptom 'Vaginal and/or Vulvar Irritation/Itching'
Subjects self-assessed symptom severity
Time frame: After 12 weeks of treatment
Symptoms of Vulvar and Vaginal Atrophy: Severity of Symptom 'Dysuria'
Subjects self-assessed symptom severity
Time frame: After 12 weeks of treatment
Symptoms of Vulvar and Vaginal Atrophy: Severity of Symptom 'Vaginal Pain Associated With Sexual Activity'
Subjects self-assessed symptom severity
Time frame: After 12 weeks of treatment
Symptoms of Vulvar and Vaginal Atrophy: Severity of Symptom 'Vaginal Bleeding Associated With Sexual Activity'
Subjects self-assessed symptom severity
Time frame: After 12 weeks of treatment
Urogenital Symptoms: Number of Participants With Symptom 'Frequent Urination'
Subjects self-assessed presence or absence of symptom
Time frame: After 12 weeks of treatment
Urogenital Symptoms: Number of Participants With Symptom 'Involuntary Urination When Laughing or Coughing'
Subjects self-assessed presence or absence of symptom
Time frame: After 12 weeks of treatment
Urogenital Symptoms: Number of Participants With Symptom 'Urination at Night'
Subjects self-assessed presence or absence of symptom; and if present recorded average number of times per night: 1; 2 to 4; more than 4.
Time frame: After 12 weeks of treatment