Efficacy and Safety Study in Postmenopausal Women to Determine the Lowest Effective Dose for Relief of Moderate to Severe Hot-Flushes
Sponsor
Bayer (Industry)
Overall Status
Completed
CT.gov ID
NCT00206622
Collaborator
(none)
425
45
3
14
9.4
0.7
Study Details
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
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.
Study Design
Study Type:
Interventional
Actual Enrollment
:
425 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
Primary Purpose:
Treatment
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 Start Date
:
Dec 1, 2004
Actual Study Completion Date
:
Feb 1, 2006
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Arm 1
|
Drug: Climara PRO (Estradiol / Levonorgestrel transdermal)
2.2mg 17 Beta-estradiol/0.69mg levonorgestrel combination transdermal patch
|
| Active Comparator: Arm 2
|
Drug: Menostar (Estradiol transdermal)
1mg 17 Beta-estradiol transdermal patch
|
| Placebo Comparator: Arm 3
|
Drug: Placebo transdermal
Placebo
|
Outcome Measures
Primary Outcome Measures
- Lowest effective dose in decreasing the frequency and severity of hot flushes []
Secondary Outcome Measures
- Other symptoms related to menopause []
Eligibility Criteria
Criteria
Ages Eligible for Study:
40 Years
and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Huntsville | Alabama | United States | 35801 | |
| 2 | Chandler | Arizona | United States | 85225 | |
| 3 | Phoenix | Arizona | United States | 85031 | |
| 4 | Tucson | Arizona | United States | 85712 | |
| 5 | Fair Oaks | California | United States | 95628 | |
| 6 | Oakland | California | United States | 94612 | |
| 7 | San Diego | California | United States | 92103 | |
| 8 | San Diego | California | United States | 92108 | |
| 9 | San Diego | California | United States | 92123 | |
| 10 | New Britain | Connecticut | United States | 06050 | |
| 11 | West Hartford | Connecticut | United States | 06117 | |
| 12 | Fort Myers | Florida | United States | 33916 | |
| 13 | Gainesville | Florida | United States | 32610-0254 | |
| 14 | Jacksonville | Florida | United States | 32216 | |
| 15 | Tampa | Florida | United States | 33613 | |
| 16 | West Palm Beach | Florida | United States | 33409 | |
| 17 | Alpharetta | Georgia | United States | 30005 | |
| 18 | Boise | Idaho | United States | 83702 | |
| 19 | Idaho Falls | Idaho | United States | 83404 | |
| 20 | Champaign | Illinois | United States | 61820 | |
| 21 | Chicago | Illinois | United States | 60612 | |
| 22 | Peoria | Illinois | United States | 61615 | |
| 23 | South Bend | Indiana | United States | 46601 | |
| 24 | Lexington | Kentucky | United States | 40536 | |
| 25 | New Orleans | Louisiana | United States | 70115 | |
| 26 | New Orleans | Louisiana | United States | 70118-1034 | |
| 27 | Detroit | Michigan | United States | 48201 | |
| 28 | St. Louis | Missouri | United States | 63110 | |
| 29 | Lincoln | Nebraska | United States | 68510 | |
| 30 | Reno | Nevada | United States | 89502 | |
| 31 | New Brunswick | New Jersey | United States | 08901 | |
| 32 | Albuquerque | New Mexico | United States | 87102 | |
| 33 | Winston-Salem | North Carolina | United States | 27103 | |
| 34 | Cincinnati | Ohio | United States | 45236 | |
| 35 | Cleveland | Ohio | United States | 44122 | |
| 36 | Columbus | Ohio | United States | 43213 | |
| 37 | Philadelphia | Pennsylvania | United States | 19114 | |
| 38 | Pittsburgh | Pennsylvania | United States | 15206 | |
| 39 | Memphis | Tennessee | United States | 38120 | |
| 40 | Arlington | Texas | United States | 76012 | |
| 41 | Houston | Texas | United States | 77004 | |
| 42 | Houston | Texas | United States | 77030 | |
| 43 | Temple | Texas | United States | 76502-1896 | |
| 44 | Salt Lake City | Utah | United States | 84124 | |
| 45 | Burlington | Vermont | United States | 05401-1420 |
Sponsors and Collaborators
- Bayer
Investigators
- Study Director: Bayer Study Director, Bayer
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00206622
Other Study ID Numbers:
- 91429
- 308261
First Posted:
Sep 21, 2005
Last Update Posted:
May 29, 2009
Last Verified:
May 1, 2009
Additional relevant MeSH terms: