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Completed

NCT Number: NCT00446199

Low-dose Hormone Therapy for Relief of Vasomotor Symptoms

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.

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Key information

Conditions

Vasomotor Symptoms Hot Flashes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

40 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Mobile, Alabama, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

0.5mg DRSP / 0.5mg E2 (BAY86-4891)

Drug

One tablet [0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).

0.25mg DRSP / 0.5mg E2 (BAY86-4891)

Drug

One tablet [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).

Estradiol (E2 0.3mg)

Drug

One tablet [17β-estradiol (E2 0.3mg)] per day taken orally for 3 cycles (28 days per cycle).

Placebo

Drug

Matching placebo tablet per day taken orally for 3 cycles (28 days per cycle).

Primary outcomes

  1. Change From Baseline to Week 12 in Weekly Frequency of Moderate to Severe Hot Flushes (Median Value)

    Time frame: 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.

  2. Change From Baseline to Week 4 in Weekly Frequency of Moderate to Severe Hot Flushes (Median Value)

    Time frame: 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.

  3. Change From Baseline to Week 12 in Weekly Mean Daily Severity of Moderate to Severe Hot Flushes (Median Value)

    Time frame: 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.

  4. Change From Baseline to Week 4 in Weekly Mean Daily Severity of Moderate to Severe Hot Flushes (Median Value)

    Time frame: 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 outcomes

  1. Change From Baseline to Week 12 in Vaginal pH

    Time frame: 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.

  2. Change From Baseline to Week 12 in Vaginal Maturation Value

    Time frame: 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.

  3. Symptoms of Vulvar and Vaginal Atrophy: Severity of Symptom 'Vaginal Dryness'

    Time frame: After 12 weeks of treatment

    Subjects self-assessed symptom severity

  4. Symptoms of Vulvar and Vaginal Atrophy: Severity of Symptom 'Vaginal and/or Vulvar Irritation/Itching'

    Time frame: After 12 weeks of treatment

    Subjects self-assessed symptom severity

  5. Symptoms of Vulvar and Vaginal Atrophy: Severity of Symptom 'Dysuria'

    Time frame: After 12 weeks of treatment

    Subjects self-assessed symptom severity

  6. Symptoms of Vulvar and Vaginal Atrophy: Severity of Symptom 'Vaginal Pain Associated With Sexual Activity'

    Time frame: After 12 weeks of treatment

    Subjects self-assessed symptom severity

  7. Symptoms of Vulvar and Vaginal Atrophy: Severity of Symptom 'Vaginal Bleeding Associated With Sexual Activity'

    Time frame: After 12 weeks of treatment

    Subjects self-assessed symptom severity

  8. Urogenital Symptoms: Number of Participants With Symptom 'Frequent Urination'

    Time frame: After 12 weeks of treatment

    Subjects self-assessed presence or absence of symptom

  9. Urogenital Symptoms: Number of Participants With Symptom 'Involuntary Urination When Laughing or Coughing'

    Time frame: After 12 weeks of treatment

    Subjects self-assessed presence or absence of symptom

  10. Urogenital Symptoms: Number of Participants With Symptom 'Urination at Night'

    Time frame: 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.

Other outcomes

  1. Change From Baseline to Week 12 in Weekly Frequency of Moderate to Severe Hot Flushes (Mean Value)

    Time frame: 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.

  2. Change From Baseline to Week 4 in Weekly Frequency of Moderate to Severe Hot Flushes (Mean Value)

    Time frame: 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.

  3. Change From Baseline to Week 12 in Weekly Mean Daily Severity of Moderate to Severe Hot Flushes (Mean Value)

    Time frame: 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 moderate to severe hot flushes minus baseline severity.

  4. Change From Baseline to Week 4 in Weekly Mean Daily Severity of Moderate to Severe Hot Flushes (Mean Value)

    Time frame: 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 moderate to severe hot flushes minus baseline severity.

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Mar 12, 2007
Registry last updated
May 6, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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