Low-dose Hormone Therapy for Relief of Vasomotor Symptoms
- Conditions
- Hot FlashesVasomotor Symptoms
- Interventions
- Drug: PlaceboDrug: 0.25mg DRSP / 0.5mg E2 (BAY86-4891)Drug: 0.5mg DRSP / 0.5mg E2 (BAY86-4891)
- Registration Number
- NCT00446199
- Lead Sponsor
- Bayer
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 735
- 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
- The usual exclusion criteria for hormone therapy apply
- Intake of medications other than hormones affecting hot flushes
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Matching placebo tablet per day taken orally for 3 cycles (28 days per cycle). 0.25mg DRSP / 0.5mg E2 (BAY86-4891) 0.25mg DRSP / 0.5mg E2 (BAY86-4891) One tablet \[0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)\] per day taken orally for 3 cycles (28 days per cycle). 0.5mg DRSP / 0.5mg E2 (BAY86-4891) 0.5mg DRSP / 0.5mg E2 (BAY86-4891) One tablet \[0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)\] per day taken orally for 3 cycles (28 days per cycle). Estradiol (E2 0.3mg) Estradiol (E2 0.3mg) One tablet \[17β-estradiol (E2 0.3mg)\] per day taken orally for 3 cycles (28 days per cycle).
- Primary Outcome Measures
Name Time Method Change From Baseline to Week 12 in Weekly Frequency of Moderate to Severe Hot Flushes (Median Value) Baseline until 12 weeks of treatment 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.
Change From Baseline to Week 4 in Weekly Frequency of Moderate to Severe Hot Flushes (Median Value) Baseline until 4 weeks of treatment 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.
Change From Baseline to Week 12 in Weekly Mean Daily Severity of Moderate to Severe Hot Flushes (Median Value) Baseline until 12 weeks of treatment 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.
Change From Baseline to Week 4 in Weekly Mean Daily Severity of Moderate to Severe Hot Flushes (Median Value) Baseline until 4 weeks of treatment 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.
- Secondary Outcome Measures
Name Time Method Change From Baseline to Week 12 in Vaginal pH Baseline until 12 weeks of treatment 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.
Change From Baseline to Week 12 in Vaginal Maturation Value Baseline until 12 weeks of treatment Calculated as (percentage of superficial cells) + 0.5 \* (percentage of intermediate cells). Absolute change calculated as week 12 value minus baseline value.
Symptoms of Vulvar and Vaginal Atrophy: Severity of Symptom 'Vaginal Dryness' After 12 weeks of treatment Subjects self-assessed symptom severity
Symptoms of Vulvar and Vaginal Atrophy: Severity of Symptom 'Vaginal and/or Vulvar Irritation/Itching' After 12 weeks of treatment Subjects self-assessed symptom severity
Symptoms of Vulvar and Vaginal Atrophy: Severity of Symptom 'Dysuria' After 12 weeks of treatment Subjects self-assessed symptom severity
Symptoms of Vulvar and Vaginal Atrophy: Severity of Symptom 'Vaginal Pain Associated With Sexual Activity' After 12 weeks of treatment Subjects self-assessed symptom severity
Urogenital Symptoms: Number of Participants With Symptom 'Involuntary Urination When Laughing or Coughing' After 12 weeks of treatment Subjects self-assessed presence or absence of symptom
Urogenital Symptoms: Number of Participants With Symptom 'Urination at Night' After 12 weeks of treatment 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.
Symptoms of Vulvar and Vaginal Atrophy: Severity of Symptom 'Vaginal Bleeding Associated With Sexual Activity' After 12 weeks of treatment Subjects self-assessed symptom severity
Urogenital Symptoms: Number of Participants With Symptom 'Frequent Urination' After 12 weeks of treatment Subjects self-assessed presence or absence of symptom