PD Study of 5 Different Oral Doses of BAY1002670

• Research type

  Research Study

• Full title

  A multi-center, randomized, double-blind, placebo-controlled, parallel group study in 60 healthy tubal-ligated women aged 18 to 45 years investigating the pharmacodynamic effects of 5 different doses (0.1 - 5 mg) BAY 1002670 after daily oral administration over 84 days.

• IRAS ID

  92043

• Contact name

  David J A Bell

• Sponsor organisation

  Bayer HealthCare, Bayer Pharma AG

• Eudract number

  2011-001760-22

• Research summary

  Uterine fibroids are common benign tumours occurring in 30-40% of all women of reproductive age. Limited treatment options are available for treating fibroids. This project plans to use BAY 1002670 for the treatment of symptomatic uterine fibroids. The main goal of this study is the demonstration of the BAY 1002670 effect on the bleeding pattern in healthy women. This is a multi-center study. A total of 60 healthy, non childbearing potential (sterilised by tubal-ligation only) women aged 18-45 who meet the eligibility criteria will be randomised into six different groups. One group will be given placebo. The other groups will be allocated to different dose ranges of BAY 1002670 (0.1mg, 0.5mg, 1mg, 2mg and 5mg). This study will evaluate the pharmacodynamic effects (effect of the study drug on the body), safety, tolerability and pharmacokinetics (the mechanisms of absorption and distribution of the study drug, the rate at which a drug action begins and the duration of the effect) of BAY1002670 after daily administration over 84 days. This study is an outpatient study. Volunteers will attend the clinic on 18 occasions; the rest of the study conduct will be carried out by the volunteers, at home, they will take the study drug at home and record level of intensity of bleeding in a diary. Participation in this study involves; ?½ Attending a screening appointment. ?½ Completing a pre-cycle period. ?½ Completing a treatment period. ?½ Completing a follow-up period. Volunteers will be involved in the study for 5-8 months including the screening visit.

• REC name

  HSC REC B

• REC reference

  11/NI/0180

• Date of REC Opinion

  5 Jan 2012

• REC opinion

  Further Information Favourable Opinion