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Completed

NCT Number: NCT01822080

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

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.

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Key information

Conditions

Endometriosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Guangzhou, Guangdong, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Dienogest (Visanne, BAY86-5258)

Drug

2 mg dienogest (DNG) once daily by mouth

Placebo

Drug

Matching placebo once daily by mouth

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Apr 2, 2013
Registry last updated
Nov 25, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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