Assess Safety and Efficacy of Vilaprisan in Subjects with Uterine Fibroids

Phase 1

• Conditions: Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]; MedDRA version: 21.1Level: LLTClassification code 10046784Term: Uterine fibroidsSystem Organ Class: 100000004864; MedDRA version: 21.1Level: LLTClassification code 10016628Term: FibroidsSystem Organ Class: 100000004864; eiomyoma; MedDRA version: 21.1Level: LLTClassification code 10022794Term: Intramural leiomyoma of uterusSystem Organ Class: 100000004864

• Registration Number: EUCTR2016-002855-48-SE
• Lead Sponsor: Bayer AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-04-18
• Last Update Posted: 13 December 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 1200

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 an acceptable non-hormonal method 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of this study is to describe the efficacy of vilaprisan in subjects with uterine fibroids compared to ulipristal.;Secondary Objective: The secondary objective of this study is to evaluate the efficacy and safety of different treatment regimens of vilaprisan in subjects with uterine fibroids.;Primary end point(s): Amenorrhea (yes/no), defined as menstrual blood loss (MBL) < 2 mL based on the menstrual pictogram (MP) during last 28 days ;Timepoint(s) of evaluation of this end point: For the primary analysis of the primary variable, the amenorrhea rates after 12 weeks of treatment in Groups A1, A2 and A3 will be compared to the rate from Group B .