Bay1002670, Fibroids, Safety and Efficacy EU,US,Can, Jap (ASTEROID 1)

Bayer

Status and phase: Completed; Phase 2

Conditions: Leiomyoma

Treatments: Drug: BAY1002670; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02131662

2013-003945-40 (EudraCT Number)

15788

Details and patient eligibility

About

The study is performed to assess the efficacy and safety of different doses of BAY1002670 in subjects with uterine fibroids. The dose-response relationship will be evaluated. Further, the study aims to establish a population pharmacokinetic/pharmacodynamic relationship for BAY1002670 in subjects with uterine fibroids. To assess the efficacy of BAY1002670 the interchangeability of menstrual pictogram and alkaline hematin method for the judgement of menstrual blood loss will be assessed.

Enrollment: 309 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Signed and dated informed consent
• Diagnosis of uterine fibroid(s) documented by transvaginal or abdominal ultrasound at screening with at least 1 fibroid with largest diameter 3.0 cm
• 18 to 50 years of age at the time of screening
• Heavy menstrual bleeding >80 mL documented by MP during the bleeding episode following the screening visit
• Normal or clinically insignificant cervical smear not requiring further follow-up
• An endometrial biopsy performed at the screening visit 1 (Visit 1), without significant histological disorder such as endometrial hyperplasia or other significant endometrial pathology
• Use of a non-hormonal barrier method of contraception starting at the bleeding episode following the screening visit 1 (Visit 1) until the end of the study
• Good general health (except for findings related to uterine fibroids)

Exclusion criteria

• Pregnancy or lactation
• Uterine fibroid with largest diameter >10.0 cm
• Hypersensitivity to any ingredient of the study drug
• Laboratory values outside inclusion range before randomization and considered as clinically relevant
• Hemoglobin values <6 g/dL or any condition requiring immediate blood transfusion (subjects with hemoglobin values <10.9 g/dL will receive iron supplementation)
• Any diseases or conditions 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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309 participants in 5 patient groups, including a placebo group

VPR 4 mg

Experimental group

Treatment:

Drug: BAY1002670

Drug: BAY1002670

Drug: BAY1002670

Drug: BAY1002670

VPR 2 mg

Experimental group

Treatment:

Drug: BAY1002670

Drug: BAY1002670

Drug: BAY1002670

Drug: BAY1002670

VPR 1 mg

Experimental group

Treatment:

Drug: BAY1002670

Drug: BAY1002670

Drug: BAY1002670

Drug: BAY1002670

VPR 0.5 mg

Experimental group

Treatment:

Drug: BAY1002670

Drug: BAY1002670

Drug: BAY1002670

Drug: BAY1002670

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo