Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids (ASTEROID 3)

Bayer

Status and phase: Terminated; Phase 3

Conditions: Uterine Fibroids

Treatments: Drug: Vilaprisan (BAY1002670); Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03400943

15787

2017-002997-38 (EudraCT Number)

Details and patient eligibility

About

The primary objective of this study was to show superiority in the treatment of HMB of vilaprisan in subjects with uterine fibroids compared to placebo.

The secondary objectives of this study were to additionally evaluate the efficacy and safety of vilaprisan in subjects with uterine fibroids.

Enrollment: 93 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women, 18 years or older in good General health
• Diagnosis of uterine fibroid(s) documented by ultrasound at screening with at least 1 fibroid with largest Diameter ≥ 30 mm and < 120 mm
• Heavy menstrual bleeding (HMB) in at least 2 bleeding periods during the Screening period each with blood loss volume of >80.00 mL documented by alkaline hematin (AH) method
• An endometrial biopsy performed during the Screening period without significant histological disorder such as endometrial hyperplasia (including simple hyperplasia) or other significant endometrial pathology
• Use of an acceptable non-hormonal method of contraception (ie, either male condom, cap, diaphragm or sponge, each in combination with spermicide) starting at Visit 1 until the end of the study

Exclusion criteria

• Pregnancy or lactation (less than 3 month since delivery, abortion, or lactation before start of Treatment)
• Hypersensitivity to any ingredient of the study drug
• Any condition requiring immediate blood transfusion
• Laboratory values outside inclusion range before randomization and considered as clinically relevant.
• 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
• Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results
• Abuse of alcohol, drugs, or medicines (eg, laxatives)
• Use of other treatments that might interfere with the conduct of the study or the interpretation of the results
• Undiagnosed abnormal genital bleeding

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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93 participants in 4 patient groups

Vilaprisan (A1)

Experimental group

Description:

Vilaprisan (2 mg) in treatment period 1 for 12 weeks and in treatment period 2 for 12 weeks, separated by 1 bleeding episode.

Treatment:

Drug: Placebo

Drug: Vilaprisan (BAY1002670)

Vilaprisan (A2)

Experimental group

Description:

Vilaprisan (2 mg) in treatment period 1 for 12 weeks and in treatment period 2 for 12 weeks without a break.

Treatment:

Drug: Vilaprisan (BAY1002670)

Placebo+Vilaprisan (B1)

Experimental group

Description:

Placebo in treatment period 1 for 12 weeks, and vilaprisan (2 mg) in treatment period 2 for 12 weeks, separated by 1 bleeding episode.

Treatment:

Drug: Placebo

Drug: Vilaprisan (BAY1002670)

Vilaprisan+Placebo (B2)

Experimental group

Description:

Vilaprisan (2 mg) in treatment period 1 for 12 weeks and placebo in treatment period 2 for 12 weeks, separated by 1 bleeding episode.

Treatment:

Drug: Placebo

Drug: Vilaprisan (BAY1002670)