Bay1002670, Fibroids, Safety and Efficacy EU,US,Can, Jap

Phase 2

Completed

• Conditions: Leiomyoma
• Interventions: Drug: BAY1002670; Drug: Placebo

• Registration Number: NCT02131662
• Lead Sponsor: Bayer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-05-05
• Study First Submitted QC: 2014-05-05
• Study First Posted: 2014-05-06
• Study Start: 2014-05-15
• Primary Completion: 2016-05-04
• Study Completion: 2016-05-04
• Disposition First Submitted: 2016-09-09
• Disposition First Submitted QC: 2016-09-09
• Disposition First Posted: 2016-09-23
• Results First Submitted: 2017-05-03
• Status Verified: 2017-11
• Results First Submitted QC: 2017-11-06
• Last Update Submitted: 2017-11-06
• Results First Posted: 2017-12-08
• Last Update Posted: 2017-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 309

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VPR 4 mg	BAY1002670	-
VPR 2 mg	BAY1002670	-
VPR 1 mg	BAY1002670	-
VPR 0.5 mg	BAY1002670	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Percentage of Subjects With Amenorrhea, Defined as no Scheduled or Unscheduled Bleeding/Spotting After the End of the Initial Bleeding Episode Until End of Treatment	After end of the initial bleeding episode until the end of treatment, up to 12 weeks	Amenorrhea was defined as no scheduled or unscheduled bleeding/spotting after the end of the initial bleeding episode until end of treatment. Dose-response curve was estimated based on the primary endpoint. The 4 parameters characterizing the dose-response curve were reported in other pre-specified endpoints below.

Secondary Outcome Measures

Name	Time	Method
Change in Volume of Menstrual Blood Loss Per 28 Days From Baseline During Treatment by Reference Period (Assessed by Alkaline Hematin Method)	From baseline to end of follow-up	In the below table, "N" signifies subjects who were evaluable for the specific parameter at that timepoint for each arm, respectively.
Time to Onset of Controlled Bleeding	During treatment period	Onset of controlled bleeding was defined by the first day, for which the MBL (assessed by MP, Version 2014) for all subsequent 28-day periods up to the end of the treatment period was less than 80 mL. Kaplan-Meier estimated time to onset of controlled bleeding (days) was reported.
Change in Volume of Largest Fibroid Compared to Baseline Measured by MRI	From baseline to end of follow-up period	Pelvic Magnetic resonance imagings (MRI), without contrast agents, were performed for volume measurements of the uterus and fibroids preferably using 1.5 Tesla scanners or higher. Images were sent to the imaging core laboratory for evaluation. Volume measurements of the uterus and fibroids were performed centrally by independent radiologist(s).