Low-dose Hormone Therapy for Relief of Vasomotor Symptoms

Hot Flashes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00446199
• Other study ID #: 91493
• Secondary ID: 310184
• Status: Completed
• Phase: Phase 3
• First received: March 9, 2007
• Last updated: April 16, 2015
• Start date: March 2007
• Est. completion date: November 2008

Study information

• Verified date: April 2015
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 735
• Est. completion date: November 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Hot Flashes
• Vasomotor Symptoms

Intervention

Drug:
• 0.5mg DRSP / 0.5mg E2 (BAY86-4891)
One tablet [0.5mg drospirenone/0.5mg 17ß-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
• 0.25mg DRSP / 0.5mg E2 (BAY86-4891)
One tablet [0.25mg drospirenone/0.5mg 17ß-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
• Estradiol (E2 0.3mg)
One tablet [17ß-estradiol (E2 0.3mg)] per day taken orally for 3 cycles (28 days per cycle).
• Placebo
Matching placebo tablet per day taken orally for 3 cycles (28 days per cycle).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

United States, 

References & Publications (3)

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 17ß-estradiol for moderate to severe vasomotor symptoms in postmenopausal women. Menopause. 20 — View 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

Sutter G, Schmelter T, Gude K, Schaefers M, Gerlinger C, Archer DF. Population pharmacokinetic/pharmacodynamic evaluation of low-dose drospirenone with 17ß-estradiol in postmenopausal women with moderate to severe vasomotor symptoms. Menopause. 2014 Mar;2 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change From Baseline to Week 12 in Weekly Frequency of Moderate to Severe Hot Flushes (Mean 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.	Baseline until 12 weeks of treatment	No
Other	Change From Baseline to Week 4 in Weekly Frequency of Moderate to Severe Hot Flushes (Mean 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.	Baseline until 4 weeks of treatment	No
Other	Change From Baseline to Week 12 in Weekly Mean Daily Severity of Moderate to Severe Hot Flushes (Mean 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 moderate to severe hot flushes minus baseline severity.	Baseline until 12 weeks of treatment	No
Other	Change From Baseline to Week 4 in Weekly Mean Daily Severity of Moderate to Severe Hot Flushes (Mean 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 moderate to severe hot flushes minus baseline severity.	Baseline until 4 weeks of treatment	No
Primary	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.	Baseline until 12 weeks of treatment	No
Primary	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.	Baseline until 4 weeks of treatment	No
Primary	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.	Baseline until 12 weeks of treatment	No
Primary	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.	Baseline until 4 weeks of treatment	No
Secondary	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.	Baseline until 12 weeks of treatment	No
Secondary	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.	Baseline until 12 weeks of treatment	No
Secondary	Symptoms of Vulvar and Vaginal Atrophy: Severity of Symptom 'Vaginal Dryness'	Subjects self-assessed symptom severity	After 12 weeks of treatment	No
Secondary	Symptoms of Vulvar and Vaginal Atrophy: Severity of Symptom 'Vaginal and/or Vulvar Irritation/Itching'	Subjects self-assessed symptom severity	After 12 weeks of treatment	No
Secondary	Symptoms of Vulvar and Vaginal Atrophy: Severity of Symptom 'Dysuria'	Subjects self-assessed symptom severity	After 12 weeks of treatment	No
Secondary	Symptoms of Vulvar and Vaginal Atrophy: Severity of Symptom 'Vaginal Pain Associated With Sexual Activity'	Subjects self-assessed symptom severity	After 12 weeks of treatment	No
Secondary	Symptoms of Vulvar and Vaginal Atrophy: Severity of Symptom 'Vaginal Bleeding Associated With Sexual Activity'	Subjects self-assessed symptom severity	After 12 weeks of treatment	No
Secondary	Urogenital Symptoms: Number of Participants With Symptom 'Frequent Urination'	Subjects self-assessed presence or absence of symptom	After 12 weeks of treatment	No
Secondary	Urogenital Symptoms: Number of Participants With Symptom 'Involuntary Urination When Laughing or Coughing'	Subjects self-assessed presence or absence of symptom	After 12 weeks of treatment	No
Secondary	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.	After 12 weeks of treatment	No

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