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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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 or disease	Intervention/treatment	Phase
Endometriosis	Drug: Dienogest (Visanne, BAY86-5258); Drug: Placebo	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	250 participants
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
Study Start Date :	March 2013
Actual Primary Completion Date :	April 2015
Actual Study Completion Date :	November 2015

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. 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 :

1. Percentage of treatment responders [ Time Frame: At 24 weeks ]
2. Score on B&B (Biberoglu and Behrman severity profile for symptoms and findings) [ Time Frame: 24 weeks after baseline ]
3. Quality of life assessed by patient questionnaire [ Time Frame: Up to 24 weeks ]
4. Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: Up to 52 weeks ]
5. 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 ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

Click here and search for drug information provided by the FDA. 

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Responsible Party:	Bayer
ClinicalTrials.gov Identifier:	NCT01822080 History of Changes
Other Study ID Numbers:	13390
First Posted:	April 2, 2013
Last Update Posted:	November 25, 2015
Last Verified:	November 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