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



Status:Completed
Healthy:No
Age Range:18 - 50
Updated:12/10/2017
Start Date:May 15, 2014
End Date:May 4, 2016

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A Randomized, Parallel-group, Double-blind, Placebo Controlled, Multi-center Study to Assess the Efficacy and Safety of Different Doses of BAY1002670 in Subjects With Uterine Fibroids Over 3 Months

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.


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
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