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
PHASE2
111 participants
INTERVENTIONAL
2011-03-31
2014-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Dienogest (Visanne, BAY86-5258)
Subjects received Dienogest tablet orally at a dosage of 2 mg once daily over a period of 52 weeks.
Dienogest (Visanne, BAY86-5258)
Subjects received Dienogest tablet orally at a dosage of 2 mg once daily over a period of 52 weeks.
Interventions
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Dienogest (Visanne, BAY86-5258)
Subjects received Dienogest tablet orally at a dosage of 2 mg once daily over a period of 52 weeks.
Eligibility Criteria
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Inclusion Criteria
* Dysmenorrhea of at least moderate intensity, with or without chronic pelvic pain, for at least 2 cycles in the previous 4 months and one of the following conditions:
* Clinically suspected endometriosis based on the presence of pelvic pain incompletely relieved by non steroidal anti-inflammatory drugs and/or oral contraceptives
* Any abdominal pain associated with ultrasound findings suggestive of endometriosis (abdominal, vaginal or rectal; only after additional specific consent and assent)
* Failure of surgical treatment for endometriosis (with cyclic or chronic pelvic pain of at least 4 months duration postsurgery)
* Threshold for endometriosis-associated pelvic pain (EAPP) score: at least 30 on a 100 units visual analog scale retrospectively evaluated at screening for the last 4 weeks
Exclusion Criteria
* Previous application of hormonal agents including oral contraceptives within 2 months, progestins, danazol within 3 months, and Gonadotropin Releasing Hormone (GnRH) agonists within 6 months prior to start of treatment
* Chronic pelvic pain that might be related to genitourinary disease or to chronic or recurrent gastrointestinal disease, including irritable bowel syndrome (defined as a disease characterized by pain relieved by defecation and irregular defecation patterns lasting at least 3 months)
* Clinically established need for primary surgical treatment of endometriosis
12 Years
17 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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Sankt Pölten, Lower Austria, Austria
Graz, Styria, Austria
Linz, Upper Austria, Austria
Graz, , Austria
Innsbruck, , Austria
Vienna, , Austria
Vienna, , Austria
Brno, , Czechia
České Budějovice, , Czechia
Písek, , Czechia
Prague, , Czechia
Prague, , Czechia
Espoo, , Finland
Helsinki, , Finland
Turku, , Finland
Angers, , France
Le Kremlin-Bicêtre, , France
Paris, , France
Rouen, , France
Erlangen, Bavaria, Germany
Hamburg, City state of Hamburg, Germany
Oldenburg, Lower Saxony, Germany
Westerstede, Lower Saxony, Germany
Münster, North Rhine-Westphalia, Germany
Lübeck, Schleswig-Holstein, Germany
Berlin, State of Berlin, Germany
Berlin, State of Berlin, Germany
Berlin, State of Berlin, Germany
Berlin, State of Berlin, Germany
Berlin, State of Berlin, Germany
Berlin, State of Berlin, Germany
Benidorm, Alicante, Spain
Vigo, Pontevedra, Spain
Seville, Sevilla, Spain
Valencia, Valencia, Spain
Seville, , Spain
Countries
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Related Links
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Click here to find information about studies related to Bayer Healthcare products conducted in Europe
Other Identifiers
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2009-017169-53
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
13788
Identifier Type: -
Identifier Source: org_study_id
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