Phase 3 Study of Dienogest for the Treatment of Endometriosis in Chinese Patients

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Endometriosis

Intervention / Treatment
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* Drug: Dienogest (Visanne, BAY86-5258)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dienogest<br>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 | Drug: Dienogest (Visanne, BAY86-5258)<br>* 2 mg dienogest (DNG) once daily by mouth<br>|
| Placebo Comparator: Placebo<br>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 | Drug: Dienogest (Visanne, BAY86-5258)<br>* 2 mg dienogest (DNG) once daily by mouth<br>Drug: Placebo<br>* Matching placebo once daily by mouth<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of endometriosis associated pelvic pain (EAPP) measured by visual analog scale (VAS) from baseline to 24 weeks |  | 24 weeks after baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endometriosis, Efficacy, Safety, Dienogest