Assessment of Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids (ASTEROID 7)

Bayer

Status and phase: Withdrawn; Phase 3

Conditions: Uterine Fibroids

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT03699176

19434

Details and patient eligibility

About

The primary objective of this study is 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 are to additionally evaluate the efficacy and safety of vilaprisan in subjects with uterine fibroids.

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 of ≥ 30 mm (alternatively, of 30 mm or more)
• 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 menstrual pictogram (MP)
• 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: Quadruple Blind

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0 participants in 2 patient groups, including a placebo group

Vilaprisan

Experimental group

Description:

2 treatment periods of 12 weeks without a break

Treatment:

Drug: Vilaprisan (BAY1002670)

Placebo

Placebo Comparator group

Description:

2 treatment periods of 12 weeks without a break

Treatment:

Drug: Placebo