check_circleStudy Completed

Endometriosis

Bayer Identifier:

13390

ClinicalTrials.gov Identifier:

NCT01822080

EudraCT Number:

Not Available

EU CT Number:

Not Available
Phase 3 study of dienogest for the treatment of endometriosis in Chinese patients

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.

Key Participants Requirements

Sex

Female

Age

18 - 45 Years
  • - 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
  • - 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
March 2013 - November 2015
Phase
Phase 3
Could I Receive a placebo
Yes
Products
Visanne (Dienogest, BAY86-5258)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Beijing, 100730, China
Terminated
Beijing, 100191, China
Completed
Beijing, 100038, China
Completed
Beijing, 100029, China
Completed
Shanghai, 200030, China
Completed
Changchun, 130021, China
Completed
Shijiazhuang, 050000, China
Completed
Dalian, 116011, China
Completed
Kunming, China
Terminated
Hengyang, 421001, China
Completed
Wuhan, 430030, China
Completed
Chengdu, 610072, China
Completed
Beijing, 100034, China
Completed
Chongqing, 400016, China
Completed
Beijing, 100026, China
Completed
Shanghai, 200127, China
Completed
Xi'an, 710061, China
Completed
Chongqing, 400042, China
Completed
Chongqing, 400010, China
Completed
Shanghai, 200011, China
Terminated
Beijing, 100044, China
Completed
Chengdu, 610041, China
Completed
Guangzhou, 510120, China
Completed
Shenyang, 110004, China
Completed
Beijing, 100020, China
Completed
Hangzhou, China

Primary Outcome

  • Change of endometriosis associated pelvic pain (EAPP) measured by visual analog scale (VAS) from baseline to 24 weeks
    date_rangeTime Frame:
    24 weeks after baseline
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    Safety Issue:
    No

Secondary Outcome

  • Percentage of treatment responders
    date_rangeTime Frame:
    At 24 weeks
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    Safety Issue:
    No
  • Score on B&B (Biberoglu and Behrman severity profile for symptoms and findings)
    date_rangeTime Frame:
    24 weeks after baseline
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    Safety Issue:
    No
  • Quality of life assessed by patient questionnaire
    date_rangeTime Frame:
    Up to 24 weeks
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    Safety Issue:
    No
  • Number of participants with adverse events as a measure of safety and tolerability
    date_rangeTime Frame:
    Up to 52 weeks
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    Safety Issue:
    Yes
  • Vaginal bleeding intensity recorded by patient diary and measured on a 5-point scale (none, spotting, light, normal, heavy)
    date_rangeTime Frame:
    Up to 52 weeks
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    Safety Issue:
    Yes

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

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