Trial Condition(s):

Endometriosis

Phase 3 study of dienogest for the treatment of endometriosis in Chinese patients

Bayer Identifier:

13390

ClinicalTrials.gov Identifier:

NCT01822080

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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.

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)

Trial Summary

Enrollment Goal
262
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
Yes
Products
Visanne (Dienogest, BAY86-5258)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Beijing, China, 100730

Status
Completed
 
Locations

Investigative Site

Beijing, China, 100191

Status
Terminated
 
Locations

Investigative Site

Beijing, China, 100038

Status
Completed
 
Locations

Investigative Site

Beijing, China, 100029

Status
Completed
 
Locations

Investigative Site

Shanghai, China, 200030

Status
Completed
 
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Investigative Site

Changchun, China, 130021

Status
Completed
 
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Investigative Site

Shijiazhuang, China, 050000

Status
Completed
 
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Investigative Site

Dalian, China, 116011

Status
Completed
 
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Investigative Site

Kunming, China

Status
Completed
 
Locations

Investigative Site

Hengyang, China, 421001

Status
Terminated
 
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Investigative Site

Wuhan, China, 430030

Status
Completed
 
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Investigative Site

Chengdu, China, 610072

Status
Completed
 
Locations

Investigative Site

Beijing, China, 100034

Status
Completed
 
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Investigative Site

Chongqing, China, 400016

Status
Completed
 
Locations

Investigative Site

Beijing, China, 100026

Status
Completed
 
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Investigative Site

Shanghai, China, 200127

Status
Completed
 
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Investigative Site

Xi'an, China, 710061

Status
Completed
 
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Investigative Site

Chongqing, China, 400042

Status
Completed
 
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Investigative Site

Chongqing, China, 400010

Status
Completed
 
Locations

Investigative Site

Shanghai, China, 200011

Status
Completed
 
Locations

Investigative Site

Beijing, China, 100044

Status
Terminated
 
Locations

Investigative Site

Chengdu, China, 610041

Status
Completed
 
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Investigative Site

Guangzhou, China, 510120

Status
Completed
 
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Investigative Site

Shenyang, China, 110004

Status
Completed
 
Locations

Investigative Site

Beijing, China, 100020

Status
Completed
 
Locations

Investigative Site

Hangzhou, China

Status
Completed
 

Trial Design