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| ID | Type | Description | Link |
|---|---|---|---|
| 308261 |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Active Comparator |
| |
| Arm 2 | Active Comparator |
| |
| Arm 3 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Climara PRO (Estradiol / Levonorgestrel transdermal) | Drug | 2.2mg 17 Beta-estradiol/0.69mg levonorgestrel combination transdermal patch |
|
| Measure | Description | Time Frame |
|---|---|---|
| Lowest effective dose in decreasing the frequency and severity of hot flushes |
| Measure | Description | Time Frame |
|---|---|---|
| Other symptoms related to menopause |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huntsville | Alabama | 35801 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17906008 | Derived | 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. |
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| Menostar (Estradiol transdermal) | Drug | 1mg 17 Beta-estradiol transdermal patch |
|
| Placebo transdermal | Drug | Placebo |
|
| Chandler |
| Arizona |
| 85225 |
| United States |
| Phoenix | Arizona | 85031 | United States |
| Tucson | Arizona | 85712 | United States |
| Fair Oaks | California | 95628 | United States |
| Oakland | California | 94612 | United States |
| San Diego | California | 92103 | United States |
| San Diego | California | 92108 | United States |
| San Diego | California | 92123 | United States |
| New Britain | Connecticut | 06050 | United States |
| West Hartford | Connecticut | 06117 | United States |
| Fort Myers | Florida | 33916 | United States |
| Gainesville | Florida | 32610-0254 | United States |
| Jacksonville | Florida | 32216 | United States |
| Tampa | Florida | 33613 | United States |
| West Palm Beach | Florida | 33409 | United States |
| Alpharetta | Georgia | 30005 | United States |
| Boise | Idaho | 83702 | United States |
| Idaho Falls | Idaho | 83404 | United States |
| Champaign | Illinois | 61820 | United States |
| Chicago | Illinois | 60612 | United States |
| Peoria | Illinois | 61615 | United States |
| South Bend | Indiana | 46601 | United States |
| Lexington | Kentucky | 40536 | United States |
| New Orleans | Louisiana | 70115 | United States |
| New Orleans | Louisiana | 70118-1034 | United States |
| Detroit | Michigan | 48201 | United States |
| St Louis | Missouri | 63110 | United States |
| Lincoln | Nebraska | 68510 | United States |
| Reno | Nevada | 89502 | United States |
| New Brunswick | New Jersey | 08901 | United States |
| Albuquerque | New Mexico | 87102 | United States |
| Winston-Salem | North Carolina | 27103 | United States |
| Cincinnati | Ohio | 45236 | United States |
| Cleveland | Ohio | 44122 | United States |
| Columbus | Ohio | 43213 | United States |
| Philadelphia | Pennsylvania | 19114 | United States |
| Pittsburgh | Pennsylvania | 15206 | United States |
| Memphis | Tennessee | 38120 | United States |
| Arlington | Texas | 76012 | United States |
| Houston | Texas | 77004 | United States |
| Houston | Texas | 77030 | United States |
| Temple | Texas | 76502-1896 | United States |
| Salt Lake City | Utah | 84124 | United States |
| Burlington | Vermont | 05401-1420 | United States |
| ID | Term |
|---|---|
| D019584 | Hot Flashes |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D004958 | Estradiol |
| ID | Term |
|---|---|
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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