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Phase 3 Study of Dienogest for the Treatment of Endometriosis in Chinese Patients
This study has been completed.
Sponsor:
Bayer
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01822080
First received: March 11, 2013
Last updated: November 24, 2015
Last verified: November 2015
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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 Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, 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 ]
Secondary Outcome Measures:
- Percentage of treatment responders [ Time Frame: At 24 weeks ]
- Score on B&B (Biberoglu and Behrman severity profile for symptoms and findings) [ Time Frame: 24 weeks after baseline ]
- Quality of life assessed by patient questionnaire [ Time Frame: Up to 24 weeks ]
- Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: 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 ]
| 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) |
| Sexes 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
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:
| 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 |
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 21, 2017