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

Endometriosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01822080
• Other study ID #: 13390
• Status: Completed
• Phase: Phase 3
• First received: March 11, 2013
• Last updated: November 24, 2015
• Start date: March 2013
• Est. completion date: November 2015

Study information

• Verified date: November 2015
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: November 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Endometriosis

Intervention

Drug:
• Dienogest (Visanne, BAY86-5258)
2 mg dienogest (DNG) once daily by mouth
• Placebo
Matching placebo once daily by mouth

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of endometriosis associated pelvic pain (EAPP) measured by visual analog scale (VAS) from baseline to 24 weeks		24 weeks after baseline	No
Secondary	Percentage of treatment responders		At 24 weeks	No
Secondary	Score on B&B (Biberoglu and Behrman severity profile for symptoms and findings)		24 weeks after baseline	No
Secondary	Quality of life assessed by patient questionnaire		Up to 24 weeks	No
Secondary	Number of participants with adverse events as a measure of safety and tolerability		Up to 52 weeks	Yes
Secondary	Vaginal bleeding intensity recorded by patient diary and measured on a 5-point scale (none, spotting, light, normal, heavy)		Up to 52 weeks	Yes

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