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Low-dose Hormone Therapy for Relief of Vasomotor Symptoms

Primary Purpose

Vasomotor Symptoms, Hot Flashes

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
0.5mg DRSP / 0.5mg E2 (BAY86-4891)
0.25mg DRSP / 0.5mg E2 (BAY86-4891)
Estradiol (E2 0.3mg)
Placebo
Sponsored by
Bayer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vasomotor Symptoms focused on measuring Vasomotor symptom relief, Postmenopausal women, Severe to Moderate Vasomotor symptoms

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

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

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

Estradiol (E2 0.3mg)

Placebo

Arm Description

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).

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

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

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.
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.
Symptoms of Vulvar and Vaginal Atrophy: Severity of Symptom 'Vaginal Dryness'
Subjects self-assessed symptom severity
Symptoms of Vulvar and Vaginal Atrophy: Severity of Symptom 'Vaginal and/or Vulvar Irritation/Itching'
Subjects self-assessed symptom severity
Symptoms of Vulvar and Vaginal Atrophy: Severity of Symptom 'Dysuria'
Subjects self-assessed symptom severity
Symptoms of Vulvar and Vaginal Atrophy: Severity of Symptom 'Vaginal Pain Associated With Sexual Activity'
Subjects self-assessed symptom severity
Symptoms of Vulvar and Vaginal Atrophy: Severity of Symptom 'Vaginal Bleeding Associated With Sexual Activity'
Subjects self-assessed symptom severity
Urogenital Symptoms: Number of Participants With Symptom 'Frequent Urination'
Subjects self-assessed presence or absence of symptom
Urogenital Symptoms: Number of Participants With Symptom 'Involuntary Urination When Laughing or Coughing'
Subjects self-assessed presence or absence of symptom
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.

Full Information

First Posted
March 9, 2007
Last Updated
April 16, 2015
Sponsor
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT00446199
Brief Title
Low-dose Hormone Therapy for Relief of Vasomotor Symptoms
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
November 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vasomotor Symptoms, Hot Flashes
Keywords
Vasomotor symptom relief, Postmenopausal women, Severe to Moderate Vasomotor symptoms

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
735 (Actual)

8. Arms, Groups, and Interventions

Arm Title
0.5mg DRSP / 0.5mg E2 (BAY86-4891)
Arm Type
Experimental
Arm Description
One tablet [0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
Arm Title
0.25mg DRSP / 0.5mg E2 (BAY86-4891)
Arm Type
Experimental
Arm Description
One tablet [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
Arm Title
Estradiol (E2 0.3mg)
Arm Type
Experimental
Arm Description
One tablet [17β-estradiol (E2 0.3mg)] per day taken orally for 3 cycles (28 days per cycle).
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matching placebo tablet per day taken orally for 3 cycles (28 days per cycle).
Intervention Type
Drug
Intervention Name(s)
0.5mg DRSP / 0.5mg E2 (BAY86-4891)
Intervention Description
One tablet [0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
Intervention Type
Drug
Intervention Name(s)
0.25mg DRSP / 0.5mg E2 (BAY86-4891)
Intervention Description
One tablet [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
Intervention Type
Drug
Intervention Name(s)
Estradiol (E2 0.3mg)
Intervention Description
One tablet [17β-estradiol (E2 0.3mg)] per day taken orally for 3 cycles (28 days per cycle).
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo tablet per day taken orally for 3 cycles (28 days per cycle).
Primary Outcome Measure Information:
Title
Change From Baseline to Week 12 in Weekly Frequency of Moderate to Severe Hot Flushes (Median Value)
Description
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
Title
Change From Baseline to Week 4 in Weekly Frequency of Moderate to Severe Hot Flushes (Median Value)
Description
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
Title
Change From Baseline to Week 12 in Weekly Mean Daily Severity of Moderate to Severe Hot Flushes (Median Value)
Description
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
Title
Change From Baseline to Week 4 in Weekly Mean Daily Severity of Moderate to Severe Hot Flushes (Median Value)
Description
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
Secondary Outcome Measure Information:
Title
Change From Baseline to Week 12 in Vaginal pH
Description
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
Title
Change From Baseline to Week 12 in Vaginal Maturation Value
Description
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
Title
Symptoms of Vulvar and Vaginal Atrophy: Severity of Symptom 'Vaginal Dryness'
Description
Subjects self-assessed symptom severity
Time Frame
After 12 weeks of treatment
Title
Symptoms of Vulvar and Vaginal Atrophy: Severity of Symptom 'Vaginal and/or Vulvar Irritation/Itching'
Description
Subjects self-assessed symptom severity
Time Frame
After 12 weeks of treatment
Title
Symptoms of Vulvar and Vaginal Atrophy: Severity of Symptom 'Dysuria'
Description
Subjects self-assessed symptom severity
Time Frame
After 12 weeks of treatment
Title
Symptoms of Vulvar and Vaginal Atrophy: Severity of Symptom 'Vaginal Pain Associated With Sexual Activity'
Description
Subjects self-assessed symptom severity
Time Frame
After 12 weeks of treatment
Title
Symptoms of Vulvar and Vaginal Atrophy: Severity of Symptom 'Vaginal Bleeding Associated With Sexual Activity'
Description
Subjects self-assessed symptom severity
Time Frame
After 12 weeks of treatment
Title
Urogenital Symptoms: Number of Participants With Symptom 'Frequent Urination'
Description
Subjects self-assessed presence or absence of symptom
Time Frame
After 12 weeks of treatment
Title
Urogenital Symptoms: Number of Participants With Symptom 'Involuntary Urination When Laughing or Coughing'
Description
Subjects self-assessed presence or absence of symptom
Time Frame
After 12 weeks of treatment
Title
Urogenital Symptoms: Number of Participants With Symptom 'Urination at Night'
Description
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
Other Pre-specified Outcome Measures:
Title
Change From Baseline to Week 12 in Weekly Frequency of Moderate to Severe Hot Flushes (Mean Value)
Description
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
Title
Change From Baseline to Week 4 in Weekly Frequency of Moderate to Severe Hot Flushes (Mean Value)
Description
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
Title
Change From Baseline to Week 12 in Weekly Mean Daily Severity of Moderate to Severe Hot Flushes (Mean Value)
Description
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.
Time Frame
Baseline until 12 weeks of treatment
Title
Change From Baseline to Week 4 in Weekly Mean Daily Severity of Moderate to Severe Hot Flushes (Mean Value)
Description
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.
Time Frame
Baseline until 4 weeks of treatment

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85225
Country
United States
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85031
Country
United States
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85741
Country
United States
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
City
Paramount
State/Province
California
ZIP/Postal Code
90723
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92121
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
City
Valley Village
State/Province
California
ZIP/Postal Code
91607
Country
United States
City
Vista
State/Province
California
ZIP/Postal Code
92083
Country
United States
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80910
Country
United States
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
City
New Britain
State/Province
Connecticut
ZIP/Postal Code
06050
Country
United States
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33437
Country
United States
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33761
Country
United States
City
Daytona Beach
State/Province
Florida
ZIP/Postal Code
32114
Country
United States
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33916
Country
United States
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
City
Lake Worth
State/Province
Florida
ZIP/Postal Code
33461
Country
United States
City
Leesburg
State/Province
Florida
ZIP/Postal Code
34748
Country
United States
City
Miami
State/Province
Florida
ZIP/Postal Code
33169
Country
United States
City
Miami
State/Province
Florida
ZIP/Postal Code
33186
Country
United States
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34655
Country
United States
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
Country
United States
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30034
Country
United States
City
Boise
State/Province
Idaho
ZIP/Postal Code
83702
Country
United States
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
City
Arlington Heights
State/Province
Illinois
ZIP/Postal Code
60004
Country
United States
City
Champaign
State/Province
Illinois
ZIP/Postal Code
61820
Country
United States
City
La Grange Park
State/Province
Illinois
ZIP/Postal Code
60526
Country
United States
City
Newburgh
State/Province
Indiana
ZIP/Postal Code
47630
Country
United States
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
City
Amite
State/Province
Louisiana
ZIP/Postal Code
70422
Country
United States
City
Marrero
State/Province
Louisiana
ZIP/Postal Code
70072
Country
United States
City
Paw Paw
State/Province
Michigan
ZIP/Postal Code
49079
Country
United States
City
Chaska
State/Province
Minnesota
ZIP/Postal Code
55318
Country
United States
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65802
Country
United States
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
City
Billings
State/Province
Montana
ZIP/Postal Code
59102
Country
United States
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68510
Country
United States
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89104
Country
United States
City
Reno
State/Province
Nevada
ZIP/Postal Code
89502
Country
United States
City
Lawrenceville
State/Province
New Jersey
ZIP/Postal Code
08648
Country
United States
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
City
Princeton
State/Province
New Jersey
ZIP/Postal Code
08540
Country
United States
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58105
Country
United States
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74105
Country
United States
City
Erie
State/Province
Pennsylvania
ZIP/Postal Code
16502
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19114
Country
United States
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15206
Country
United States
City
Wexford
State/Province
Pennsylvania
ZIP/Postal Code
15090
Country
United States
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29201
Country
United States
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57105
Country
United States
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37403
Country
United States
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
City
Dallas
State/Province
Texas
ZIP/Postal Code
75234
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23294
Country
United States
City
Renton
State/Province
Washington
ZIP/Postal Code
98055
Country
United States
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23963309
Citation
Sutter G, Schmelter T, Gude K, Schaefers M, Gerlinger C, Archer DF. Population pharmacokinetic/pharmacodynamic evaluation of low-dose drospirenone with 17beta-estradiol in postmenopausal women with moderate to severe vasomotor symptoms. Menopause. 2014 Mar;21(3):236-42. doi: 10.1097/GME.0b013e31829c12e8.
Results Reference
result
PubMed Identifier
23963307
Citation
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 17beta-estradiol for moderate to severe vasomotor symptoms in postmenopausal women. Menopause. 2014 Mar;21(3):227-35. doi: 10.1097/GME.0b013e31829c1431.
Results Reference
result
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, 2012 * 2012, P-36, p 1388
Results Reference
result
PubMed Identifier
22228322
Citation
Gerlinger C, Gude K, Hiemeyer F, Schmelter T, Schafers M. An empirically validated responder definition for the reduction of moderate to severe hot flushes in postmenopausal women. Menopause. 2012 Jul;19(7):799-803. doi: 10.1097/gme.0b013e31823de8ba.
Results Reference
derived

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Low-dose Hormone Therapy for Relief of Vasomotor Symptoms

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