Study in Healthy Tubal Ligated Women to Evaluate Pharmacodynamics, Safety and Pharmacokinetics of BAY1002670

April 18, 2014 updated by: Bayer

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) BAY1002670 After Daily Oral Administration Over 84 Days

Effects of BAY1002670 on bleeding pattern: non-bleeding rate; on endometrium; on ovarian function; return of menstrual bleeding after treatment; safety and tolerability; PK/PD (pharmacokinetic/pharmacodynamic) relationship

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

73

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Antwerpen, Belgium, 2060
  • Germany
      • Berlin, Germany, 10117
      • Berlin, Germany, 13353
    • Bayern
      • Neu-Ulm, Bayern, Germany, 89231
    • Nordrhein-Westfalen
      • Neuss, Nordrhein-Westfalen, Germany, 41450
  • United Kingdom
      • Belfast, United Kingdom, BT2 7BA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Healthy female subjects
  • Sterilized by tubal ligation
  • Age 18-45 years
  • Body mass index (BMI) at screening: ≥ 18 and ≤ 32 kg/m²
  • At least 3 consecutive regular menstrual cycles with a cycle length of 24 - 35 days before first screening examination according to the subject's history
  • Absence of clinically relevant abnormal findings in the pre-treatment endometrial biopsy

Exclusion Criteria:

  • Regular use of medicines (incl. anabolics)
  • Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal
  • Amenorrhea for more than 3 months within the last 6 months before the first screening examination
  • Lacking suitability for frequent transvaginal ultrasonography (TVU) examinations
  • Clinically relevant findings (e.g. blood pressure, electrocardiogram [ECG], physical and gynecological examination, laboratory examination)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BAY1002670 [0.1mg]
0.1 mg BAY1002670, oral administration, four tablets to be taken daily, 84 consecutive days
Drug: BAY1002670
Experimental: BAY1002670 [0.5mg]
0.5 mg BAY1002670, oral administration, four tablets to be taken daily, 84 consecutive days
Drug: BAY1002670
Experimental: BAY1002670 [1.0mg]
1.0 mg BAY1002670, oral administration, four tablets to be taken daily, 84 consecutive days
Drug: BAY1002670
Experimental: BAY1002670 [2.0mg]
2.0 mg BAY1002670, oral administration, four tablets to be taken daily, 84 consecutive days
Drug: BAY1002670
Experimental: BAY1002670 [5.0mg]
5.0 mg BAY1002670, oral administration, four tablets to be taken daily, 84 consecutive days
Drug: BAY1002670
Placebo Comparator: Placebo
Placebo for BAY1002670, oral administration, four tablets to be taken daily, 84 consecutive days
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Non-bleeding rate (i.e. women without bleeding from treatment day 9 until the end of treatment)
Time Frame: After three months
After three months

Secondary Outcome Measures

Outcome Measure
Time Frame
Return of menstrual bleeding after treatment
Time Frame: Up to two months after last treatment
Up to two months after last treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

March 20, 2013

First Submitted That Met QC Criteria

March 20, 2013

First Posted (Estimate)

March 22, 2013

Study Record Updates

Last Update Posted (Estimate)

April 21, 2014

Last Update Submitted That Met QC Criteria

April 18, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14723
  • 2011-001760-22 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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