Completed

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

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Dienogest (Visanne, BAY86-5258)

+ Dienogest (Visanne, BAY86-5258)

+ Placebo

Drug
Who is being recruted

Urogenital Diseases+3

+ Genital Diseases

+ Female Urogenital Diseases and Pregnancy Complications

From 18 to 45 Years
+16 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 3
Interventional
Study Start: March 2013
See protocol details

Summary

Principal SponsorBayer
Last updated: November 25, 2015
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2013

Actual date on which the first participant was enrolled.

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.

NCT01822080
Principal SponsorBayer
Last updated: November 25, 2015
Sourced from a government-validated database.Claim as a partner

Protocol

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

250 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

From 18 to 45 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesGenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsGenital Diseases, FemaleFemale Urogenital DiseasesEndometriosis

Criteria

5 inclusion criteria required to participate
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
Women between 18 and 45 years of age, inclusive
Show More Criteria
11 exclusion criteria prevent from participating
Amenorrhea (more than three consecutive months in the six months before screening)
Any disease or condition that may worsen under hormonal treatment
Before menarche or after menopause
Contra-indication for the supportive analgesic medication (ibuprofen)
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
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

Group II

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 26 locations

Guangzhou, ChinaOpen in Google Maps

Shijiazhuang, China

Wuhan, China

Hengyang, China
Completed26 Study Centers