Assess Safety and Efficacy of Vilaprisan in Subjects with Uterine Fibroids

Phase 1

• Conditions: leiomyoma; MedDRA version: 20.0Level: LLTClassification code 10016628Term: FibroidsSystem Organ Class: 100000004864; MedDRA version: 20.0Level: LLTClassification code 10046784Term: Uterine fibroidsSystem Organ Class: 100000004864; MedDRA version: 20.0Level: LLTClassification code 10022794Term: Intramural leiomyoma of uterusSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

• Registration Number: EUCTR2016-002855-48-IT
• Lead Sponsor: BAYER HEALTHCARE AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-02-08
• Last Update Posted: 7 September 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 996

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: 1
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 996
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 including
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 assess the efficacy of vilaprisan<br>in subjects with uterine fibroids compared to ulipristal.;Secondary Objective: The secondary objective of this study is to evaluate the efficacy and<br>safety of different treatment regimens of vilaprisan in subjects with<br>uterine fibroids;Primary end point(s): Amenorrhea (yes/no), Defined as menstrual blood loss (MBL) < 2 mL<br>based on the menstrual pictogram (MP) during last 28 days of the<br>treatment period.;Timepoint(s) of evaluation of this end point: At 3 months and 9 months