Assessment of Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids

NCT ID: NCT03699176

Last Updated: 2020-01-18

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-27
• Study Completion Date: 2019-12-25

Brief Summary

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.

Conditions

Uterine Fibroids

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Vilaprisan

2 treatment periods of 12 weeks without a break

Group Type: EXPERIMENTAL

Vilaprisan (BAY1002670)

Intervention Type: DRUG

2 mg, once daily, oral

Placebo

2 treatment periods of 12 weeks without a break

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Once daily, oral

Interventions

Vilaprisan (BAY1002670)

2 mg, once daily, oral

Intervention Type: DRUG

Placebo

Once daily, oral

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Funabashi Municipal Medical Center

Funabashi, Chiba, Japan

Matsudo City General Hospital

Matsudo, Chiba, Japan

Ena Odori Clinic

Sapporo, Hokkaido, Japan

Tokeidai Memorial Clinic

Sapporo, Hokkaido, Japan

Asahi clinic

Takamatsu, Kagawa-ken, Japan

Kagawa Prefectural Central Hospital

Takamatsu, Kagawa-ken, Japan

Unoki Clinic

Kagoshima, , Japan

Japanese Red Cross Kumamoto Hospital

Kumamoto, , Japan

Countries

Japan

Other Identifiers

19434

Identifier Type: -

Identifier Source: org_study_id