Phase 3 Study of Dienogest for the Treatment of Endometriosis in Chinese Patients
NCT ID: NCT01822080
Last Updated: 2015-11-25
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
250 participants
INTERVENTIONAL
2013-03-31
2015-11-30
Brief Summary
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There will be 2 study phases: a double-blind, randomized, placebo-controlled, parallel-group phase over 24 weeks, and an open-label extension phase with 2 mg DNG daily p.o. over 28 weeks for all subjects who completed the double-blind phase, irrespective of their treatment assignment in the first study phase.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Dienogest
50% of the participants will be randomized to this arm and will receive 2 mg dienogest (DNG) once daily by mouth from 0-52 weeks
Dienogest (Visanne, BAY86-5258)
2 mg dienogest (DNG) once daily by mouth
Placebo
50% of the participants will be randomized to this arm and will receive placebo once daily by mouth from 0-24 weeks then switch to 2 mg dienogest (DNG) once daily by mouth from 25-52 weeks
Dienogest (Visanne, BAY86-5258)
2 mg dienogest (DNG) once daily by mouth
Placebo
Matching placebo once daily by mouth
Interventions
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Dienogest (Visanne, BAY86-5258)
2 mg dienogest (DNG) once daily by mouth
Placebo
Matching placebo once daily by mouth
Eligibility Criteria
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Inclusion Criteria
* Women with endometriosis confirmed by laparoscopy or laparotomy within ten years but no later than 2 weeks before the Screening Visit
* A score of at least 30 on a 100 mm visual analog scale (VAS) for endometriosis-associated pelvic pain at Screening Visit and Baseline Visit
* Good general health (except for findings related to endometriosis, with or without infertility), as evidenced by medical history and complete physical and gynecological examination
* Willingness to use a barrier method of contraception is required
Exclusion Criteria
* Wish for pregnancy within intended treatment period
* Before menarche or after menopause
* Amenorrhea (more than three consecutive months in the six months before screening)
* Undiagnosed abnormal genital bleeding
* Previous/use of hormonal agents
* Any disease or condition that may worsen under hormonal treatment
* Signs and/or symptoms of therapy-resistant endometriosis despite more than one prior attempt at drug treatment or surgical therapy
* Need for primary surgical treatment of endometriosis
* Regular use of pain medication due to other underlying diseases
* Contra-indication for the supportive analgesic medication (ibuprofen)
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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Guangzhou, Guangdong, China
Shijiazhuang, Hebei, China
Wuhan, Hubei, China
Hengyang, Hunan, China
Changchun, Jilin, China
Dalian, Liaoning, China
Shenyang, Liaoning, China
Xi'an, Shaanxi, China
Chengdu, Sichuan, China
Chengdu, Sichuan, China
Hangzhou, Zhejiang, China
Beijing, , China
Beijing, , China
Beijing, , China
Beijing, , China
Beijing, , China
Beijing, , China
Beijing, , China
Beijing, , China
Chongqing, , China
Chongqing, , China
Chongqing, , China
Kunming, , China
Shanghai, , China
Shanghai, , China
Shanghai, , China
Countries
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References
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Yu Q, Zhang S, Li H, Wang P, Zvolanek M, Ren X, Dong L, Lang J. Dienogest for Treatment of Endometriosis in Women: A 28-Week, Open-Label, Extension Study. J Womens Health (Larchmt). 2019 Feb;28(2):170-177. doi: 10.1089/jwh.2018.7084. Epub 2018 Nov 21.
Other Identifiers
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13390
Identifier Type: -
Identifier Source: org_study_id