A Study to Assess the Safety and Efficacy of Vilaprisan in Japanese Subjects With Uterine Fibroids and Heavy Menstrual Bleeding (ASTEROID 8)

Bayer

Status and phase: Terminated; Phase 3

Conditions: Uterine Fibroids and Heavy Menstrual Bleeding

Treatments: Drug: Vilaprisan (BAY1002670)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03476928

19435

Details and patient eligibility

About

To evaluate the safety and efficacy of vilaprisan in Japanese subjects with uterine fibroids and heavy menstrual bleeding (HMB).

Enrollment: 153 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 years or older
• Diagnosis of uterine fibroid(s) documented by ultrasound at screening
• Heavy menstrual bleeding (HMB) >80.00 mL associated with uterine fibroid(s)
• Good general health
• Normal or clinically insignificant cervical smear
• An endometrial biopsy performed during the screening period, without significant histological disorder
• Use of an acceptable nonhormonal method of contraception 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
• Any condition requiring immediate blood transfusion
• 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 the results
• Undiagnosed abnormal genital bleeding

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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153 participants in 2 patient groups

Treatment Group A1

Experimental group

Description:

4 treatment periods of 12 weeks, each separated by 1 bleeding episode

Treatment:

Drug: Vilaprisan (BAY1002670)

Treatment Group A2

Experimental group

Description:

2 treatment periods of 24 weeks, separated by 2 bleeding episodes

Treatment:

Drug: Vilaprisan (BAY1002670)