Phase 3 Study of Dienogest for the Treatment of Endometriosis in Chinese Patients - Full Text View

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.

Condition	Intervention	Phase
Endometriosis	Drug: Dienogest (Visanne, BAY86-5258) Drug: Placebo	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Endometriosis

Drug Information available for: Dienogest

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:

Change of endometriosis associated pelvic pain (EAPP) measured by visual analog scale (VAS) from baseline to 24 weeks [ Time Frame: 24 weeks after baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Percentage of treatment responders [ Time Frame: At 24 weeks ] [ Designated as safety issue: No ]
Score on B&B (Biberoglu and Behrman severity profile for symptoms and findings) [ Time Frame: 24 weeks after baseline ] [ Designated as safety issue: No ]
Quality of life assessed by patient questionnaire [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: No ]
Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: Up to 52 weeks ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]


Enrollment:	250
Study Start Date:	March 2013
Study Completion Date:	November 2015
Primary Completion Date:	April 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility


Ages Eligible for Study:	18 Years to 45 Years (Adult)
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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)

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01822080

Locations


China, Guangdong

Guangzhou, Guangdong, China, 510120
China, Hebei

Shijiazhuang, Hebei, China, 050000
China, Hubei

Wuhan, Hubei, China, 430030
China, Hunan

Hengyang, Hunan, China, 421001
China, Jilin

Changchun, Jilin, China
China, Liaoning

Dalian, Liaoning, China, 116011

Shenyang, Liaoning, China, 110004
China, Shaanxi

Xi'an, Shaanxi, China, 710061
China, Sichuan

Chengdu, Sichuan, China, 610041

Chengdu, Sichuan, China, 610072
China, Zhejiang

Hangzhou, Zhejiang, China
China

Beijing, China, 100020

Beijing, China, 100026

Beijing, China, 100029

Beijing, China, 100032

Beijing, China, 100034

Beijing, China, 100038

Beijing, China, 100044

Beijing, China, 100083

Chongqing, China, 400010

Chongqing, China, 400016

Chongqing, China, 400042

Kunming, China

Shanghai, China, 200011

Shanghai, China, 200030

Shanghai, China, 200127

Sponsors and Collaborators

Bayer

Investigators


Study Director:	Bayer Study Director	Bayer

More Information

Additional Information:

Click here and search for drug information provided by the FDA. This link exits the ClinicalTrials.gov site

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product. This link exits the ClinicalTrials.gov site


Responsible Party:	Bayer
ClinicalTrials.gov Identifier:	NCT01822080 History of Changes
Other Study ID Numbers:	13390
Study First Received:	March 11, 2013
Last Updated:	November 24, 2015
Health Authority:	China: Food and Drug Administration

Keywords provided by Bayer:


Endometriosis Efficacy Safety Dienogest

Additional relevant MeSH terms:


Endometriosis Genital Diseases, Female Dienogest Nandrolone Contraceptive Agents, Male Contraceptive Agents Reproductive Control Agents Physiological Effects of Drugs Contraceptives, Oral	Contraceptive Agents, Female Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents Androgens Hormones Anabolic Agents

ClinicalTrials.gov processed this record on September 28, 2016