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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
250
2 mg dienogest (DNG) once daily by mouth
Matching placebo once daily by mouth
Unnamed facility
Guangzhou, Guangdong, China
Unnamed facility
Shijiazhuang, Hebei, China
Change of endometriosis associated pelvic pain (EAPP) measured by visual analog scale (VAS) from baseline to 24 weeks
Time frame: 24 weeks after baseline
Percentage of treatment responders
Time frame: At 24 weeks
Score on B&B (Biberoglu and Behrman severity profile for symptoms and findings)
Time frame: 24 weeks after baseline
Quality of life assessed by patient questionnaire
Time frame: Up to 24 weeks
Number of participants with adverse events as a measure of safety and tolerability
Time frame: Up to 52 weeks
Vaginal bleeding intensity recorded by patient diary and measured on a 5-point scale (none, spotting, light, normal, heavy)
Time frame: Up to 52 weeks
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Unnamed facility
Wuhan, Hubei, China
Unnamed facility
Hengyang, Hunan, China
Unnamed facility
Changchun, Jilin, China
Unnamed facility
Dalian, Liaoning, China
Unnamed facility
Shenyang, Liaoning, China
Unnamed facility
Xi'an, Shaanxi, China
Unnamed facility
Chengdu, Sichuan, China
Unnamed facility
Chengdu, Sichuan, China
...and 16 more locations