Assess safety and efficacy of vilaprisan in subjects with endometriosis
- Conditions
- Pre-menopausal women 18 years and older with confirmed endometriosis and moderate to severe endometriosis-associated pelvic pain (EAPP), otherwise in good general health.MedDRA version: 20.0Level: PTClassification code 10014778Term: EndometriosisSystem Organ Class: 10038604 - Reproductive system and breast disordersTherapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
- Registration Number
- EUCTR2013-004768-72-BG
- Lead Sponsor
- Bayer AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 315
1. Signed and dated informed consent
2. Pre-menopausal women 18 years (inclusive) and above at the time of Visit 1
3. Women with endometriosis confirmed by laparoscopy or laparotomy OR diagnosed based on imaging
4. Moderate to severe endometriosis-associated pelvic pain (EAPP)
5. Adherence to screening period diary entries
6. Willingness to use only standardized pain medication if needed
7. Good general health (except for findings related to endometriosis)
8. Normal or clinically insignificant cervical cytology not requiring further follow-up
9. An endometrial biopsy performed at the screening phase without significant histological disorder
10. Use of an acceptable non-hormonal method of contraception
11. Willingness / ability to comply with electronic diary entry for the duration of study participation
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 315
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1. Pregnancy or lactation (less than 3 months since delivery, abortion, or lactation before Visit 1)
2. Hypersensitivity to any ingredient of the study treatments
3. Laboratory values outside the inclusion range before randomization, and considered clinically relevant
4. Any diseases or conditions that can compromise the function of the body systems and could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study drug including abnormal liver parameters
5. Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results
6. Undiagnosed abnormal genital bleeding
7. Abuse of alcohol, drugs, or medicines (e.g. laxatives) as evaluated by the investigator
8. Use of other treatments that might interfere with the conduct of the study or the interpretation of the results
9. Endometriosis-specific treatments for symptom relief except rescue pain medication according to protocol
10. Simultaneous participation in another clinical trial with investigational medicinal product(s). Participation in another trial prior to study entry that might have an impact on the study objectives, at the discretion of the investigator
11. Inability to cooperate with the study procedures for any reason
12. Previous assignment to treatment (e.g. randomization) during this study (allowing previously randomized subjects to be re-included into the study may lead to bias)
13. Hypersensitivity to any ingredient of standardized pain medication
14. Wish for pregnancy during the study
15. Regular use of pain medication due to other underlying diseases
16. Non-responsiveness of EAPP to GnRH-a
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method