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| ID | Type | Description | Link |
|---|---|---|---|
| 307059 | Other Identifier | company internal |
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The purpose of this study is to demonstrate safety and efficacy of SH T00660AA for the treatment of endometriosis
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Visanne (SH T00660AA , BAY86-5258) | Drug | Daily long-term drug treatment (12 months), and post-treatment observation (6 months) in a subgroup of patients |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety assessment of the drug | 12-18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy (reduction of pelvic pain) | 12-18 months |
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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 |
|---|---|---|---|---|---|---|
| Heidelberg | Baden-Wurttemberg | 69115 | Germany | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20444534 | Result | Strowitzki T, Faustmann T, Gerlinger C, Seitz C. Dienogest in the treatment of endometriosis-associated pelvic pain: a 12-week, randomized, double-blind, placebo-controlled study. Eur J Obstet Gynecol Reprod Biol. 2010 Aug;151(2):193-8. doi: 10.1016/j.ejogrb.2010.04.002. Epub 2010 May 5. | |
| 19819448 | Result | Kohler G, Faustmann TA, Gerlinger C, Seitz C, Mueck AO. A dose-ranging study to determine the efficacy and safety of 1, 2, and 4mg of dienogest daily for endometriosis. Int J Gynaecol Obstet. 2010 Jan;108(1):21-5. doi: 10.1016/j.ijgo.2009.08.020. |
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| Tübingen |
| Baden-Wurttemberg |
| 72076 |
| Germany |
| Krumbach | Bavaria | 86381 | Germany |
| München | Bavaria | 81241 | Germany |
| Nuremberg | Bavaria | 90419 | Germany |
| Giessen | Hesse | 35392 | Germany |
| Mühlheim am Main | Hesse | 63165 | Germany |
| Aachen | North Rhine-Westphalia | 52074 | Germany |
| Gevelsberg | North Rhine-Westphalia | 58285 | Germany |
| Münster | North Rhine-Westphalia | 48129 | Germany |
| Dippoldiswalde | Saxony | 01744 | Germany |
| Leipzig | Saxony | 04103 | Germany |
| Marienberg | Saxony | 09496 | Germany |
| Weißig | Saxony | 01474 | Germany |
| Kalbe | Saxony-Anhalt | 39624 | Germany |
| Lübeck | Schleswig-Holstein | 23538 | Germany |
| Greifswald | 17487 | Germany |
| Brescia | 25123 | Italy |
| Cagliari | 09042 | Italy |
| Naples | 80138 | Italy |
| Roma | 00165 | Italy |
| Torino | 10127 | Italy |
| Chernivtsi | 58017 | Ukraine |
| Kiev | 01030 | Ukraine |
| Kiev | 04050 | Ukraine |
| Kiev | 04107 | Ukraine |
| Kiev | 04210 | Ukraine |
| Vinnitsa | 21000 | Ukraine |
| 21106059 | Result | Gerlinger C, Schumacher U, Faustmann T, Colligs A, Schmitz H, Seitz C. Defining a minimal clinically important difference for endometriosis-associated pelvic pain measured on a visual analog scale: analyses of two placebo-controlled, randomized trials. Health Qual Life Outcomes. 2010 Nov 24;8:138. doi: 10.1186/1477-7525-8-138. |
| 21681516 | Result | Petraglia F, Hornung D, Seitz C, Faustmann T, Gerlinger C, Luisi S, Lazzeri L, Strowitzki T. Reduced pelvic pain in women with endometriosis: efficacy of long-term dienogest treatment. Arch Gynecol Obstet. 2012 Jan;285(1):167-73. doi: 10.1007/s00404-011-1941-7. Epub 2011 Jun 17. |
| ID | Term |
|---|---|
| D004715 | Endometriosis |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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