Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
319 participants
INTERVENTIONAL
2014-10-16
2016-10-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Placebo
Placebo intravaginal ring (treatment for 84 days, 28 days wearing period for each ring) and Placebo 3-months depot intramuscular injection
Placebo
Placebo intravaginal ring (treatment for 84 days, 28 days wearing period for each ring) and Placebo 3-months depot intramuscular injection
Levonorgestrel
Levonorgestrel 40 µg/d intravaginal ring (treatment for 84 days, 28 days wearing period for each ring) and Placebo 3-months depot intramuscular injection
Placebo
Placebo intravaginal ring (treatment for 84 days, 28 days wearing period for each ring) and Placebo 3-months depot intramuscular injection
Levonorgestrel
Levonorgestrel 40 µg/d intravaginal ring (treatment for 84 days, 28 days wearing period for each ring) and Placebo 3-months depot intramuscular injection
Anastrozole 300 µg/d + Levonorgestrel
Anastrozole 300 µg/d + Levonorgestrel 40 µg/d intravaginal ring (treatment for 84 days, 28 days wearing period for each ring) and Placebo 3-months depot intramuscular injection
Placebo
Placebo intravaginal ring (treatment for 84 days, 28 days wearing period for each ring) and Placebo 3-months depot intramuscular injection
Anastrozole
Participants received Anastrozole 300 µg/d or 600 µg/d or 1050 µg/d + Levonorgestrel 40 µg/d intravaginal ring (treatment for 84 days, 28 days wearing period for each ring) and Placebo 3-months depot intramuscular injection
Anastrozole 600 µg/d + Levonorgestrel
Anastrozole 600 µg/d + Levonorgestrel 40 µg/d intravaginal ring (treatment for 84 days, 28 days wearing period for each ring) and Placebo 3-months depot intramuscular injection
Placebo
Placebo intravaginal ring (treatment for 84 days, 28 days wearing period for each ring) and Placebo 3-months depot intramuscular injection
Anastrozole
Participants received Anastrozole 300 µg/d or 600 µg/d or 1050 µg/d + Levonorgestrel 40 µg/d intravaginal ring (treatment for 84 days, 28 days wearing period for each ring) and Placebo 3-months depot intramuscular injection
Anastrozole 1050 µg/d + Levonorgestrel
Anastrozole 1050 µg/d + Levonorgestrel 40 µg/d intravaginal ring (treatment for 84 days, 28 days wearing period for each ring) and Placebo 3-months depot intramuscular injection
Placebo
Placebo intravaginal ring (treatment for 84 days, 28 days wearing period for each ring) and Placebo 3-months depot intramuscular injection
Anastrozole
Participants received Anastrozole 300 µg/d or 600 µg/d or 1050 µg/d + Levonorgestrel 40 µg/d intravaginal ring (treatment for 84 days, 28 days wearing period for each ring) and Placebo 3-months depot intramuscular injection
Lupron / Leuprolide acetate
Placebo intravaginal ring (treatment for 84 days, 28 days wearing period for each ring) and Lupron / Leuprolide acetate 11.25 mg 3-months depot intramuscular injection
Placebo
Placebo intravaginal ring (treatment for 84 days, 28 days wearing period for each ring) and Placebo 3-months depot intramuscular injection
Lupron / Leuprolide acetate
Placebo intravaginal ring (treatment for 84 days, 28 days wearing period for each ring) and Lupron / Leuprolide acetate 11.25 mg 3-months depot intramuscular injection
Interventions
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Placebo
Placebo intravaginal ring (treatment for 84 days, 28 days wearing period for each ring) and Placebo 3-months depot intramuscular injection
Levonorgestrel
Levonorgestrel 40 µg/d intravaginal ring (treatment for 84 days, 28 days wearing period for each ring) and Placebo 3-months depot intramuscular injection
Anastrozole
Participants received Anastrozole 300 µg/d or 600 µg/d or 1050 µg/d + Levonorgestrel 40 µg/d intravaginal ring (treatment for 84 days, 28 days wearing period for each ring) and Placebo 3-months depot intramuscular injection
Lupron / Leuprolide acetate
Placebo intravaginal ring (treatment for 84 days, 28 days wearing period for each ring) and Lupron / Leuprolide acetate 11.25 mg 3-months depot intramuscular injection
Eligibility Criteria
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Inclusion Criteria
* Women with endometriosis confirmed by laparoscopy or laparotomy within the last ten years but not less than 8 weeks before the screening visit In Japan, diagnosis based on imaging (transvaginal ultrasound or MRI) also qualifies for inclusion.
* Moderate to severe endometriosis-associated pelvic pain (EAPP) of ≥5 in the last 28 days before screening visit 1 measured on the numeric rating scale (NRS; i.e. 4-week recall period).
* At randomization: Adherence to the study procedures during the screening period, at least 24 diary entries of ESD item 1 during the last 28 consecutive days before the randomization visit, and a sum of the available ESD item 1 ('worst pain' on the daily NRS) entries during this period of at least 98 (corresponding to an average score of ≥ 3.5).
* Willingness to use only ibuprofen as rescue pain medication for EAPP, if needed according to investigator's instruction.
* Use of a non-hormonal barrier method (i.e. spermicide-coated condoms) for contraception from screening visit until the end of the study. This is not required if adequate contraception is achieved by vasectomy of the partner
Exclusion Criteria
* Any diseases or conditions that can compromise the function of the body systems and could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study drug
* Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results.
* Any disease or condition that may worsen under hormonal treatment according to the assessment and opinion of the investigator.
* Undiagnosed abnormal genital bleeding
* Wish for pregnancy during the study
* Regular use of pain medication due to other underlying diseases
* Non-responsiveness of endometriosis associated pelvic pain (EAPP) to GnRH-a or surgery (partial response is not exclusionary).
18 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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San Diego, California, United States
San Francisco, California, United States
Gainesville, Florida, United States
New Port Richey, Florida, United States
Atlanta, Georgia, United States
Sandy Springs, Georgia, United States
Chicago, Illinois, United States
Palos Heights, Illinois, United States
Wichita, Kansas, United States
Marrero, Louisiana, United States
Canton, Michigan, United States
Detroit, Michigan, United States
Saginaw, Michigan, United States
Lincoln, Nebraska, United States
Neptune City, New Jersey, United States
Plainsboro, New Jersey, United States
Durham, North Carolina, United States
Greensboro, North Carolina, United States
Winston-Salem, North Carolina, United States
Columbus, Ohio, United States
Dayton, Ohio, United States
Philadelphia, Pennsylvania, United States
Chattanooga, Tennessee, United States
Seattle, Washington, United States
Madison, Wisconsin, United States
Villach, Carinthia, Austria
Innsbruck, Tyrol, Austria
Linz, Upper Austria, Austria
Vienna, , Austria
Bruxelles - Brussel, , Belgium
Bruxelles - Brussel, , Belgium
Edegem, , Belgium
Ghent, , Belgium
Hamilton, Ontario, Canada
Ottawa, Ontario, Canada
Toronto, Ontario, Canada
Montreal, Quebec, Canada
Québec, , Canada
Brno, , Czechia
Brno, , Czechia
České Budějovice, , Czechia
Hradec Králové, , Czechia
Olomouc, , Czechia
Pilsen, , Czechia
Písek, , Czechia
Prague, , Czechia
Tábor, , Czechia
Aarhus N, , Denmark
Copenhagen, , Denmark
Odense C, , Denmark
Espoo, , Finland
Helsinki, , Finland
Hyvinkää, , Finland
Jyväskylä, , Finland
Kuopio, , Finland
Oulu, , Finland
Turku, , Finland
Karlsruhe, Baden-Wurttemberg, Germany
Mannheim, Baden-Wurttemberg, Germany
Erlangen, Bavaria, Germany
München, Bavaria, Germany
Aachen, North Rhine-Westphalia, Germany
Cologne, North Rhine-Westphalia, Germany
Dippoldiswalde, Saxony, Germany
Dresden, Saxony, Germany
Bernburg, Saxony-Anhalt, Germany
Blankenburg, Saxony-Anhalt, Germany
Jena, Thuringia, Germany
Berlin, , Germany
Berlin, , Germany
Hamburg, , Germany
Hamburg, , Germany
Kitakyushu, Fukuoka, Japan
Sapporo, Hokkaido, Japan
Sapporo, Hokkaido, Japan
Sapporo, Hokkaido, Japan
Sapporo, Hokkaido, Japan
Kawanishi, Hyōgo, Japan
Kanazawa, Ishikawa-ken, Japan
Kurashiki, Okayama-ken, Japan
Sayama, Osaka, Japan
Hamamatsu, Shizuoka, Japan
Bunkyo-ku, Tokyo, Japan
Minatoku, Tokyo, Japan
Shinagawa-ku, Tokyo, Japan
Kumamoto, , Japan
Nagano, , Japan
Osaka, , Japan
Almere Stad, , Netherlands
Groningen, , Netherlands
Nieuwegein, , Netherlands
Zwolle, , Netherlands
Asker, , Norway
Stokmarknes, , Norway
Tromsø, , Norway
Trondheim, , Norway
Tønsberg, , Norway
Bialystok, , Poland
Katowice, , Poland
Krakow, , Poland
Lodz, , Poland
Lublin, , Poland
Szczecin, , Poland
Łęczna, , Poland
Aravaca, Madrid, Spain
Collado Villalba, Madrid, Spain
Pozuelo de Alarcón, Madrid, Spain
Barcelona, , Spain
Barcelona, , Spain
Seville, , Spain
Valencia, , Spain
Valencia, , Spain
Vitoria-Gasteiz, Álava, Spain
Lausanne, Canton of Vaud, Switzerland
Bern, , Switzerland
Frauenklinik, , Switzerland
Lucerne, , Switzerland
Countries
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Related Links
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Click here to find information about studies related to Bayer AG products conducted in Europe.
Other Identifiers
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2013-005090-53
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
15832
Identifier Type: -
Identifier Source: org_study_id
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