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

November 24, 2015 updated by: Bayer

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

250

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100044
      • Beijing, China, 100020
      • Beijing, China, 100029
      • Beijing, China, 100083
      • Beijing, China, 100026
      • Beijing, China, 100034
      • Beijing, China, 100038
      • Beijing, China, 100032
      • Chongqing, China, 400010
      • Chongqing, China, 400042
      • Chongqing, China, 400016
      • Kunming, China
      • Shanghai, China, 200127
      • Shanghai, China, 200030
      • Shanghai, China, 200011
    • Guangdong
      • Guangzhou, Guangdong, China, 510120
    • Hebei
      • Shijiazhuang, Hebei, China, 050000
    • Hubei
      • Wuhan, Hubei, China, 430030
    • Hunan
      • Hengyang, Hunan, China, 421001
    • Jilin
      • Changchun, Jilin, China
    • Liaoning
      • Dalian, Liaoning, China, 116011
      • Shenyang, Liaoning, China, 110004
    • Shaanxi
      • Xi'an, Shaanxi, China, 710061
    • Sichuan
      • Chengdu, Sichuan, China, 610041
      • Chengdu, Sichuan, China, 610072
    • Zhejiang
      • Hangzhou, Zhejiang, China

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of treatment responders
Time Frame: At 24 weeks
At 24 weeks
Score on B&B (Biberoglu and Behrman severity profile for symptoms and findings)
Time Frame: 24 weeks after baseline
24 weeks after baseline
Quality of life assessed by patient questionnaire
Time Frame: Up to 24 weeks
Up to 24 weeks
Number of participants with adverse events as a measure of safety and tolerability
Time Frame: Up to 52 weeks
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
Up to 52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

March 11, 2013

First Submitted That Met QC Criteria

March 27, 2013

First Posted (Estimate)

April 2, 2013

Study Record Updates

Last Update Posted (Estimate)

November 25, 2015

Last Update Submitted That Met QC Criteria

November 24, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13390

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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