Clinical trial NCT01822080: Phase 3 Study of Dienogest for the Treatment of Endometriosis in Chinese Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Endometriosis
Keywords: Endometriosis
Efficacy
Safety
Dienogest
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2013-04-02
Enrollment: 250
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Change of endometriosis associated pelvic pain (EAPP) measured by visual analog scale (VAS) from baseline to 24 weeks
timeFrame: 24 weeks after baseline
Secondary outcomes:
measure: Percentage of treatment responders
timeFrame: At 24 weeks
measure: Score on B&B (Biberoglu and Behrman severity profile for symptoms and findings)
timeFrame: 24 weeks after baseline
measure: Quality of life assessed by patient questionnaire
timeFrame: Up to 24 weeks
measure: Number of participants with adverse events as a measure of safety and tolerability
timeFrame: Up to 52 weeks
measure: Vaginal bleeding intensity recorded by patient diary and measured on a 5-point scale (none, spotting, light, normal, heavy)
timeFrame: Up to 52 weeks
Other outcomes:
Locations:
city: Guangzhou
country: China
state: Guangdong
city: Shijiazhuang
country: China
state: Hebei
city: Wuhan
country: China
state: Hubei
city: Hengyang
country: China
state: Hunan
city: Changchun
country: China
state: Jilin
city: Dalian
country: China
state: Liaoning
city: Shenyang
country: China
state: Liaoning
city: Xi'an
country: China
state: Shaanxi
city: Chengdu
country: China
state: Sichuan
city: Chengdu
country: China
state: Sichuan
city: Hangzhou
country: China
state: Zhejiang
city: Beijing
country: China
city: Beijing
country: China
city: Beijing
country: China
city: Beijing
country: China
city: Beijing
country: China
city: Beijing
country: China
city: Beijing
country: China
city: Beijing
country: China
city: Chongqing
country: China
city: Chongqing
country: China
city: Chongqing
country: China
city: Kunming
country: China
city: Shanghai
country: China
city: Shanghai
country: China
city: Shanghai
country: China
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: 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.