A Study to Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids (ASTEROID 5)

Bayer

Status and phase: Terminated; Phase 3

Conditions: Uterine Fibroids

Treatments: Drug: Vilaprisan (BAY1002670)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03240523

15789

2016-002855-48 (EudraCT Number)

Details and patient eligibility

About

The primary objective of this study is to describe the efficacy of vilaprisan in subjects with uterine fibroids compared to ulipristal.

The secondary objective of this study is to evaluate the efficacy and safety of different treatment regimens of vilaprisan in subjects with uterine fibroids.

Enrollment: 766 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women, 18 years or older at the time of Visit 1
• 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
• Heavy menstrual bleeding (HMB) >80.00 mL documented by menstrual pictogram (MP) in a bleeding episode period during the screening period
• Use of an acceptable non-hormonal method of contraception
• An endometrial biopsy performed during the screening period, without significant histological disorder such as endometrial hyperplasia (including simple hyperplasia) or other significant endometrial pathology

Exclusion criteria

• Pregnancy or lactation (less than 3 months since delivery, abortion, or lactation before start of treatment)
• Hypersensitivity to any ingredient of the study drugs
• 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)
• 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
• Abuse of alcohol, drugs, or medicines (eg: laxatives)
• Undiagnosed abnormal genital bleeding
• Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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766 participants in 3 patient groups

Group A1: Vilaprisan (3/1 regimen)

Experimental group

Description:

Orally, 2 mg, once daily, 3 months treatment followed by 1 menstrual bleeding episode

Treatment:

Drug: Vilaprisan (BAY1002670)

Group A2: Vilaprisan (6/2 regimen)

Experimental group

Description:

Orally, 2 mg, once daily, 6 months treatment followed by 2 menstrual bleeding episodes

Treatment:

Drug: Vilaprisan (BAY1002670)

Group A3/B (3/2 regimen)

Experimental group

Description:

Orally, 2 mg, once daily, 3 months treatment followed by 2 menstrual bleeding episodes With protocol version 5.0 the blinded study arms A3 and B were converted to one open-label study arm called A3/B.

Treatment:

Drug: Vilaprisan (BAY1002670)