Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids (ASTEROID 4)

Bayer

Status and phase: Terminated; Phase 3

Conditions: Uterine Fibroids

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT03400956

15790

2016-003561-26 (EudraCT Number)

Details and patient eligibility

About

The primary objective of this study was to show superiority of vilaprisan in the treatment of heavy menstrual bleeding (HMB) 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: 103 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 more than 30 mm and less than 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 the 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 months since delivery, abortion, or lactation before start of treatment)
• Hypersensitivity to any ingredient of the study drug
• 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
• 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 (e.g. laxatives)
• Use of other treatments that might interfere with the conduct of the study or the interpretation of results
• Undiagnosed abnormal genital bleeding

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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103 participants in 3 patient groups

Vilaprisan (A1)

Experimental group

Description:

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

Treatment:

Drug: Vilaprisan (BAY1002670)

Placebo+Vilaprisan (B1)

Experimental group

Description:

Placebo in treatment period 1 for 12 weeks, and vilaprisan 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 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)