Endometriosis
Conditions
Keywords
Endometriosis, Efficacy, Safety, Dienogest
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.
Interventions
2 mg dienogest (DNG) once daily by mouth
DRUGPlacebo
Matching placebo once daily by mouth
Sponsors
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change of endometriosis associated pelvic pain (EAPP) measured by visual analog scale (VAS) from baseline to 24 weeks | 24 weeks after baseline |
Secondary
| Measure | Time frame |
|---|---|
| Score on B&B (Biberoglu and Behrman severity profile for symptoms and findings) | 24 weeks after baseline |
| Quality of life assessed by patient questionnaire | Up to 24 weeks |
| Percentage of treatment responders | At 24 weeks |
| Number of participants with adverse events as a measure of safety and tolerability | Up to 52 weeks |
| Vaginal bleeding intensity recorded by patient diary and measured on a 5-point scale (none, spotting, light, normal, heavy) | Up to 52 weeks |
Countries
China
Outcome results
None listed