|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||||||||||||||
| Sponsor: | Bayer |
|---|---|
| Information provided by: | Bayer |
| ClinicalTrials.gov Identifier: | NCT00206622 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Hot Flashes |
Drug: Climara PRO (Estradiol / Levonorgestrel transdermal) Drug: Menostar (Estradiol transdermal) Drug: Placebo transdermal |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| 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 |
| Enrollment: | 425 |
| Study Start Date: | December 2004 |
| Study Completion Date: | February 2006 |
| Arms | Assigned Interventions |
|---|---|
| Arm 1: Active Comparator |
Drug: Climara PRO (Estradiol / Levonorgestrel transdermal)
2.2mg 17 Beta-estradiol/0.69mg levonorgestrel combination transdermal patch
|
| Arm 2: Active Comparator |
Drug: Menostar (Estradiol transdermal)
1mg 17 Beta-estradiol transdermal patch
|
| Arm 3: Placebo Comparator |
Drug: Placebo transdermal
Placebo
|
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| Huntsville, Alabama, United States, 35801 | |
| United States, Arizona | |
| Phoenix, Arizona, United States, 85031 | |
| Tucson, Arizona, United States, 85712 | |
| Chandler, Arizona, United States, 85225 | |
| United States, California | |
| San Diego, California, United States, 92123 | |
| San Diego, California, United States, 92103 | |
| San Diego, California, United States, 92108 | |
| Fair Oaks, California, United States, 95628 | |
| Oakland, California, United States, 94612 | |
| United States, Connecticut | |
| West Hartford, Connecticut, United States, 06117 | |
| New Britain, Connecticut, United States, 06050 | |
| United States, Florida | |
| West Palm Beach, Florida, United States, 33409 | |
| Jacksonville, Florida, United States, 32216 | |
| Gainesville, Florida, United States, 32610-0254 | |
| Tampa, Florida, United States, 33613 | |
| Fort Myers, Florida, United States, 33916 | |
| United States, Georgia | |
| Alpharetta, Georgia, United States, 30005 | |
| United States, Idaho | |
| Idaho Falls, Idaho, United States, 83404 | |
| Boise, Idaho, United States, 83702 | |
| United States, Illinois | |
| Peoria, Illinois, United States, 61615 | |
| Chicago, Illinois, United States, 60612 | |
| Champaign, Illinois, United States, 61820 | |
| United States, Indiana | |
| South Bend, Indiana, United States, 46601 | |
| United States, Kentucky | |
| Lexington, Kentucky, United States, 40536 | |
| United States, Louisiana | |
| New Orleans, Louisiana, United States, 70115 | |
| New Orleans, Louisiana, United States, 70118-1034 | |
| United States, Michigan | |
| Detroit, Michigan, United States, 48201 | |
| United States, Missouri | |
| St. Louis, Missouri, United States, 63110 | |
| United States, Nebraska | |
| Lincoln, Nebraska, United States, 68510 | |
| United States, Nevada | |
| Reno, Nevada, United States, 89502 | |
| United States, New Jersey | |
| New Brunswick, New Jersey, United States, 08901 | |
| United States, New Mexico | |
| Albuquerque, New Mexico, United States, 87102 | |
| United States, North Carolina | |
| Winston-Salem, North Carolina, United States, 27103 | |
| United States, Ohio | |
| Cincinnati, Ohio, United States, 45236 | |
| Columbus, Ohio, United States, 43213 | |
| Cleveland, Ohio, United States, 44122 | |
| United States, Pennsylvania | |
| Pittsburgh, Pennsylvania, United States, 15206 | |
| Philadelphia, Pennsylvania, United States, 19114 | |
| United States, Tennessee | |
| Memphis, Tennessee, United States, 38120 | |
| United States, Texas | |
| Houston, Texas, United States, 77004 | |
| Arlington, Texas, United States, 76012 | |
| Temple, Texas, United States, 76502-1896 | |
| Houston, Texas, United States, 77030 | |
| United States, Utah | |
| Salt Lake City, Utah, United States, 84124 | |
| United States, Vermont | |
| Burlington, Vermont, United States, 05401-1420 | |
| Study Director: | Bayer Study Director | Bayer |
More Information
| Responsible Party: | Bayer HealthCare Pharmaceuticals, Inc. ( Therapeutic Area Head ) |
| Study ID Numbers: | 91429, 308261 |
| Study First Received: | September 12, 2005 |
| Last Updated: | May 28, 2009 |
| ClinicalTrials.gov Identifier: | NCT00206622 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Estrogens Contraceptive Agents Contraceptives, Oral Estradiol valerate Physiological Effects of Drugs Contraceptive Agents, Female Hot Flashes Hormones, Hormone Substitutes, and Hormone Antagonists Reproductive Control Agents Estradiol 17 beta-cypionate |
Hormones Estradiol Pharmacologic Actions Signs and Symptoms Therapeutic Uses Estradiol 3-benzoate Levonorgestrel Contraceptives, Oral, Synthetic Polyestradiol phosphate |
