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

Phase 3

Completed

• Conditions: Endometriosis
• Interventions: Drug: Dienogest (Visanne, BAY86-5258); Drug: Placebo

• Registration Number: NCT01822080
• Lead Sponsor: Bayer

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-03-11
• Study First Submitted QC: 2013-03-27
• Study First Posted: 2013-04-02
• Primary Completion: 2015-04
• Status Verified: 2015-11
• Study Completion: 2015-11
• Last Update Submitted: 2015-11-24
• Last Update Posted: 2015-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 250

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dienogest	Dienogest (Visanne, BAY86-5258)	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
Placebo	Dienogest (Visanne, BAY86-5258)	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
Placebo	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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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