Back to resultsEfficacy and Safety Study in Postmenopausal Women to Determine the Lowest Effective Dose for Relief of Moderate to Severe Hot-Flushes
Primary Purpose
Hot Flashes
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Climara PRO (Estradiol / Levonorgestrel transdermal)
Menostar (Estradiol transdermal)
Placebo transdermal
Sponsored by
About this trial
This is an interventional treatment trial for Hot Flashes
Eligibility Criteria
Inclusion Criteria: Menopause Reporting a minimum of 7 moderate to severe hot flushes per day for at least 1 week (7 consecutive days), or a minimum of 50 moderate to severe hot flushes per week for at least 1 week (7 consecutive days) Exclusion Criteria: Hormonal treatment Contraindication to estrogen/progestogen therapy
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
Arm 1
Arm 2
Arm 3
Arm Description
Outcomes
Primary Outcome Measures
Lowest effective dose in decreasing the frequency and severity of hot flushes
Secondary Outcome Measures
Other symptoms related to menopause
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00206622
Brief Title
Efficacy and Safety Study in Postmenopausal Women to Determine the Lowest Effective Dose for Relief of Moderate to Severe Hot-Flushes
Official Title
A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study Comparing a 2.2mg 17 Beta-Estradiol/0.69mg Levonorgestrel Combination Transdermal Patch, and a 1mg 17 Beta-Estradiol Transdermal Patch With a Placebo Patch in Postmenopausal Women to Determine the Lowest Effective Dose of Estradiol for the Relief of Moderate to Severe Hot Flushes
Study Type
Interventional
2. Study Status
Record Verification Date
May 2009
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Bayer
4. Oversight
5. Study Description
Brief Summary
To determine the lowest effective dose of estradiol by comparing E2/LNG (2.2mg/0.69mg) and E2 (1.0mg) dose with placebo in decreasing the frequency and severity of moderate to severe hot flushes in postmenopausal women
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
Hot Flashes
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
425 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Active Comparator
Arm Title
Arm 2
Arm Type
Active Comparator
Arm Title
Arm 3
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Climara PRO (Estradiol / Levonorgestrel transdermal)
Intervention Description
2.2mg 17 Beta-estradiol/0.69mg levonorgestrel combination transdermal patch
Intervention Type
Drug
Intervention Name(s)
Menostar (Estradiol transdermal)
Intervention Description
1mg 17 Beta-estradiol transdermal patch
Intervention Type
Drug
Intervention Name(s)
Placebo transdermal
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Lowest effective dose in decreasing the frequency and severity of hot flushes
Secondary Outcome Measure Information:
Title
Other symptoms related to menopause
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Menopause
Reporting a minimum of 7 moderate to severe hot flushes per day for at least 1 week (7 consecutive days), or a minimum of 50 moderate to severe hot flushes per week for at least 1 week (7 consecutive days)
Exclusion Criteria:
Hormonal treatment
Contraindication to estrogen/progestogen therapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
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
Fair Oaks
State/Province
California
ZIP/Postal Code
95628
Country
United States
City
Oakland
State/Province
California
ZIP/Postal Code
94612
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
92123
Country
United States
City
New Britain
State/Province
Connecticut
ZIP/Postal Code
06050
Country
United States
City
West Hartford
State/Province
Connecticut
ZIP/Postal Code
06117
Country
United States
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33916
Country
United States
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610-0254
Country
United States
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
Country
United States
City
Alpharetta
State/Province
Georgia
ZIP/Postal Code
30005
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
Champaign
State/Province
Illinois
ZIP/Postal Code
61820
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61615
Country
United States
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46601
Country
United States
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70118-1034
Country
United States
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68510
Country
United States
City
Reno
State/Province
Nevada
ZIP/Postal Code
89502
Country
United States
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45236
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
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19114
Country
United States
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15206
Country
United States
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
City
Arlington
State/Province
Texas
ZIP/Postal Code
76012
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
Temple
State/Province
Texas
ZIP/Postal Code
76502-1896
Country
United States
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
Country
United States
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401-1420
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
17906008
Citation
Bachmann GA, Schaefers M, Uddin A, Utian WH. Lowest effective transdermal 17beta-estradiol dose for relief of hot flushes in postmenopausal women: a randomized controlled trial. Obstet Gynecol. 2007 Oct;110(4):771-9. doi: 10.1097/01.AOG.0000284450.51264.31.
Results Reference
derived
Learn more about this trial
Efficacy and Safety Study in Postmenopausal Women to Determine the Lowest Effective Dose for Relief of Moderate to Severe Hot-Flushes
We'll reach out to this number within 24 hrs