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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01822080
First received: March 11, 2013
Last updated: September 29, 2014
Last verified: September 2014
  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:


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: 175
Study Start Date: March 2013
Estimated Study Completion Date: November 2015
Estimated 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
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, 610072
Chengdu, Sichuan, China, 610041
China, Zhejiang
Hangzhou, Zhejiang, China
China
Beijing, China, 100020
Beijing, China, 100034
Beijing, China, 100026
Beijing, China, 100083
Beijing, China, 100730
Beijing, China, 100038
Beijing, China, 100044
Beijing, China, 100029
Chongqing, China, 400016
Chongqing, China, 400042
Chongqing, China, 400010
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:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01822080     History of Changes
Other Study ID Numbers: 13390
Study First Received: March 11, 2013
Last Updated: September 29, 2014
Health Authority: China: Food and Drug Administration

Keywords provided by Bayer:
Endometriosis
Efficacy
Safety
Dienogest

Additional relevant MeSH terms:
Endometriosis
Genital Diseases, Female
Dienogest
Contraceptive Agents, Male
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptives, Oral
Contraceptive Agents, Female
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on September 30, 2014