Low-dose Hormone Therapy for Relief of Vasomotor Symptoms

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00446199
First received: March 9, 2007
Last updated: July 1, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Vasomotor Symptoms
Hot Flashes
Drug: 0.5mg DRSP / 0.5mg E2 (BAY86-4891)
Drug: 0.25mg DRSP / 0.5mg E2 (BAY86-4891)
Drug: Estradiol (E2 0.3mg)
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline until 4 weeks of treatment ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline until 12 weeks of treatment ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline until 4 weeks of treatment ] [ Designated as safety issue: No ]
    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:
  • Change From Baseline to Week 12 in Vaginal pH [ Time Frame: Baseline until 12 weeks of treatment ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline until 12 weeks of treatment ] [ Designated as safety issue: No ]
    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' [ Time Frame: After 12 weeks of treatment ] [ Designated as safety issue: No ]
    Subjects self-assessed symptom severity

  • Symptoms of Vulvar and Vaginal Atrophy: Severity of Symptom 'Vaginal and/or Vulvar Irritation/Itching' [ Time Frame: After 12 weeks of treatment ] [ Designated as safety issue: No ]
    Subjects self-assessed symptom severity

  • Symptoms of Vulvar and Vaginal Atrophy: Severity of Symptom 'Dysuria' [ Time Frame: After 12 weeks of treatment ] [ Designated as safety issue: No ]
    Subjects self-assessed symptom severity

  • Symptoms of Vulvar and Vaginal Atrophy: Severity of Symptom 'Vaginal Pain Associated With Sexual Activity' [ Time Frame: After 12 weeks of treatment ] [ Designated as safety issue: No ]
    Subjects self-assessed symptom severity

  • Symptoms of Vulvar and Vaginal Atrophy: Severity of Symptom 'Vaginal Bleeding Associated With Sexual Activity' [ Time Frame: After 12 weeks of treatment ] [ Designated as safety issue: No ]
    Subjects self-assessed symptom severity

  • Urogenital Symptoms: Number of Participants With Symptom 'Frequent Urination' [ Time Frame: After 12 weeks of treatment ] [ Designated as safety issue: No ]
    Subjects self-assessed presence or absence of symptom

  • Urogenital Symptoms: Number of Participants With Symptom 'Involuntary Urination When Laughing or Coughing' [ Time Frame: After 12 weeks of treatment ] [ Designated as safety issue: No ]
    Subjects self-assessed presence or absence of symptom

  • Urogenital Symptoms: Number of Participants With Symptom 'Urination at Night' [ Time Frame: After 12 weeks of treatment ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 (Mean Value) [ Time Frame: Baseline until 4 weeks of treatment ] [ Designated as safety issue: No ]
    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 (Mean Value) [ Time Frame: Baseline until 12 weeks of treatment ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 735
Study Start Date: March 2007
Study Completion Date: November 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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).
Drug: 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).
Experimental: 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).
Drug: 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).
Experimental: Estradiol (E2 0.3mg)
One tablet [17β-estradiol (E2 0.3mg)] per day taken orally for 3 cycles (28 days per cycle).
Drug: Estradiol (E2 0.3mg)
One tablet [17β-estradiol (E2 0.3mg)] per day taken orally for 3 cycles (28 days per cycle).
Placebo Comparator: Placebo
Matching placebo tablet per day taken orally for 3 cycles (28 days per cycle).
Drug: Placebo
Matching placebo tablet per day taken orally for 3 cycles (28 days per cycle).

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

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00446199

  Show 76 Study Locations
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00446199     History of Changes
Other Study ID Numbers: 91493, 310184
Study First Received: March 9, 2007
Results First Received: March 23, 2012
Last Updated: July 1, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Bayer:
Vasomotor symptom relief
Postmenopausal women
Severe to Moderate Vasomotor symptoms

Additional relevant MeSH terms:
Hot Flashes
Signs and Symptoms
Estradiol
Polyestradiol phosphate
Drospirenone
Estradiol valerate
Estradiol 17 beta-cypionate
Estradiol 3-benzoate
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Contraceptive Agents
Reproductive Control Agents
Therapeutic Uses
Contraceptive Agents, Female
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Diuretics, Potassium Sparing
Diuretics
Natriuretic Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on August 01, 2014