Safety and Efficacy of SH T00660AA in Treatment of Endometriosis
NCT ID: NCT00225186
Last Updated: 2014-01-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
168 participants
INTERVENTIONAL
2004-07-31
2008-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Arm 1
Visanne (SH T00660AA , BAY86-5258)
Daily long-term drug treatment (12 months), and post-treatment observation (6 months) in a subgroup of patients
Interventions
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Visanne (SH T00660AA , BAY86-5258)
Daily long-term drug treatment (12 months), and post-treatment observation (6 months) in a subgroup of patients
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* History or suspicion of hormone dependent tumor
* Therapy resistant endometriosis or need for primary surgical treatment
* Any other conditions which forbid the participation
18 Years
45 Years
FEMALE
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Heidelberg, Baden-Wurttemberg, Germany
Tübingen, Baden-Wurttemberg, Germany
Krumbach, Bavaria, Germany
München, Bavaria, Germany
Nuremberg, Bavaria, Germany
Giessen, Hesse, Germany
Mühlheim am Main, Hesse, Germany
Aachen, North Rhine-Westphalia, Germany
Gevelsberg, North Rhine-Westphalia, Germany
Münster, North Rhine-Westphalia, Germany
Dippoldiswalde, Saxony, Germany
Leipzig, Saxony, Germany
Marienberg, Saxony, Germany
Weißig, Saxony, Germany
Kalbe, Saxony-Anhalt, Germany
Lübeck, Schleswig-Holstein, Germany
Greifswald, , Germany
Brescia, , Italy
Cagliari, , Italy
Napoli, , Italy
Roma, , Italy
Torino, , Italy
Chernivtsi, , Ukraine
Kiev, , Ukraine
Kiev, , Ukraine
Kiev, , Ukraine
Kiev, , Ukraine
Vinnitsa, , Ukraine
Countries
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References
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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.
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.
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.
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.
Other Identifiers
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307059
Identifier Type: OTHER
Identifier Source: secondary_id
91234
Identifier Type: -
Identifier Source: org_study_id
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