Phase 3 Study of Dienogest for the Treatment of Endometriosis in Chinese Patients
A Multicenter Study to Investigate the Efficacy and Safety of Daily Oral Administration of 2 mg Dienogest Tablets (Visanne/SH T00660AA) for the Treatment of Endometriosis in Chinese Patients: a Double-blind, Randomized, Placebo-controlled, Parallel Group Phase Over 24 Weeks Followed by an Open-label, Single-group Follow up Over 28 Weeks
1 other identifier
interventional
250
1 country
26
Brief Summary
This study is aimed to evaluate efficacy and safety of dienogest 2 mg oral tablets in the treatment of endometriosis. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Mar 2013
Typical duration for phase_3
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2013
CompletedFirst Submitted
Initial submission to the registry
March 11, 2013
CompletedFirst Posted
Study publicly available on registry
April 2, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2015
CompletedNovember 25, 2015
November 1, 2015
2.1 years
March 11, 2013
November 24, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change of endometriosis associated pelvic pain (EAPP) measured by visual analog scale (VAS) from baseline to 24 weeks
24 weeks after baseline
Secondary Outcomes (5)
Percentage of treatment responders
At 24 weeks
Score on B&B (Biberoglu and Behrman severity profile for symptoms and findings)
24 weeks after baseline
Quality of life assessed by patient questionnaire
Up to 24 weeks
Number of participants with adverse events as a measure of safety and tolerability
Up to 52 weeks
Vaginal bleeding intensity recorded by patient diary and measured on a 5-point scale (none, spotting, light, normal, heavy)
Up to 52 weeks
Study Arms (2)
Dienogest
EXPERIMENTAL50% of the participants will be randomized to this arm and will receive 2 mg dienogest (DNG) once daily by mouth from 0-52 weeks
Placebo
PLACEBO COMPARATOR50% 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
Interventions
Eligibility Criteria
You may qualify if:
- Women between 18 and 45 years of age, inclusive
- 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
You may not qualify if:
- Pregnancy or lactation (less than three months since delivery, abortion, or lactation before start of treatment)
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (26)
Unknown Facility
Guangzhou, Guangdong, 510120, China
Unknown Facility
Shijiazhuang, Hebei, 050000, China
Unknown Facility
Wuhan, Hubei, 430030, China
Unknown Facility
Hengyang, Hunan, 421001, China
Unknown Facility
Changchun, Jilin, China
Unknown Facility
Dalian, Liaoning, 116011, China
Unknown Facility
Shenyang, Liaoning, 110004, China
Unknown Facility
Xi'an, Shaanxi, 710061, China
Unknown Facility
Chengdu, Sichuan, 610041, China
Unknown Facility
Chengdu, Sichuan, 610072, China
Unknown Facility
Hangzhou, Zhejiang, China
Unknown Facility
Beijing, 100020, China
Unknown Facility
Beijing, 100026, China
Unknown Facility
Beijing, 100029, China
Unknown Facility
Beijing, 100032, China
Unknown Facility
Beijing, 100034, China
Unknown Facility
Beijing, 100038, China
Unknown Facility
Beijing, 100044, China
Unknown Facility
Beijing, 100083, China
Unknown Facility
Chongqing, 400010, China
Unknown Facility
Chongqing, 400016, China
Unknown Facility
Chongqing, 400042, China
Unknown Facility
Kunming, China
Unknown Facility
Shanghai, 200011, China
Unknown Facility
Shanghai, 200030, China
Unknown Facility
Shanghai, 200127, China
Related Publications (1)
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.
PMID: 30461337DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 11, 2013
First Posted
April 2, 2013
Study Start
March 1, 2013
Primary Completion
April 1, 2015
Study Completion
November 1, 2015
Last Updated
November 25, 2015
Record last verified: 2015-11