EUCTR2016-002855-48-DEActive, not recruitingPhase 1
A randomized, parallel-group, multicenter study to assess the efficacy and safety of vilaprisan in subjects with uterine fibroids - ASTEROID 5
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Bayer AG
- Enrollment
- 1,200
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- Female
Inclusion Criteria
- •1. Women, 18 years or older at the time of Visit 1
- •2. Diagnosis of uterine fibroid(s) documented by ultrasound at screening with at least 1 fibroid with largest diameter more than 30 mm and less than 120 mm
- •3. Heavy menstrual bleeding (HMB) >80.0 mL documented by menstrual pictogram (MP) in a bleeding episode period during the screening period
- •4.Use of double-barrier nonhormonal methods of contraception
- •5. An endometrial biopsy performed during the screening period, without significant histological disorder such as endometrial hyperplasia (including simple hyperplasia) or other significant endometrial pathology.
- •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 1200
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •1. Pregnancy or lactation (less than 3 months since delivery, abortion, or lactation before start of treatment)
- •2. Hypersensitivity to any ingredient of the study drugs
- •3. Hemoglobin values =6 g/dL or any condition requiring immediate blood transfusion (subjects with hemoglobin values =10.9 g/dL will be recommended to use iron supplementation).
- •4. Any diseases, conditions, or medications 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
- •5. Abuse of alcohol, drugs, or medicines (eg, laxatives)
- •6. Undiagnosed abnormal genital bleeding
- •7. Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results.
Investigators
Similar Trials
Active, not recruiting
Phase 1
Assess Safety and Efficacy of Vilaprisan in Subjects with Uterine FibroidseiomyomaMedDRA version: 21.1Level: LLTClassification code 10046784Term: Uterine fibroidsSystem Organ Class: 100000004864MedDRA version: 21.1Level: LLTClassification code 10016628Term: FibroidsSystem Organ Class: 100000004864MedDRA version: 21.1Level: LLTClassification code 10022794Term: Intramural leiomyoma of uterusSystem Organ Class: 100000004864EUCTR2016-002855-48-SKBayer AG766
Completed
Phase 3
A randomized, parallel-group, multicenter study to assess the efficacy and safety of vilaprisan in subjects with uterine fibroidsleiomyomauterine fibroids10013326NL-OMON48550Bayer18
Active, not recruiting
Phase 1
Assess Safety and Efficacy of Vilaprisan in Subjects with Uterine FibroidseiomyomaMedDRA version: 20.0Level: LLTClassification code 10046784Term: Uterine fibroidsSystem Organ Class: 100000004864MedDRA version: 20.0Level: LLTClassification code 10016628Term: FibroidsSystem Organ Class: 100000004864MedDRA version: 20.0Level: LLTClassification code 10022794Term: Intramural leiomyoma of uterusSystem Organ Class: 100000004864EUCTR2016-002855-48-CZBayer AG766
Active, not recruiting
Phase 1
Assess Safety and Efficacy of Vilaprisan in Subjects with Uterine FibroidsEUCTR2016-002855-48-NOBayer AG1,200
Active, not recruiting
Phase 1
Assess Safety and Efficacy of Vilaprisan in Subjects with Uterine FibroidseiomyomaMedDRA version: 21.1Level: LLTClassification code 10046784Term: Uterine fibroidsSystem Organ Class: 100000004864MedDRA version: 21.1Level: LLTClassification code 10016628Term: FibroidsSystem Organ Class: 100000004864MedDRA version: 21.1Level: LLTClassification code 10022794Term: Intramural leiomyoma of uterusSystem Organ Class: 100000004864EUCTR2016-002855-48-ATBayer AG1,200