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

Phase 1

Completed

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

• Registration Number: NCT01816815
• Lead Sponsor: Bayer

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11
• Primary Completion: 2012-10
• Study Completion: 2013-01
• Study First Submitted: 2013-03-20
• Study First Submitted QC: 2013-03-20
• Study First Posted: 2013-03-22
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-18
• Last Update Posted: 2014-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 73

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BAY1002670 [0.5mg]	BAY1002670	0.5 mg BAY1002670, oral administration, four tablets to be taken daily, 84 consecutive days
BAY1002670 [0.1mg]	BAY1002670	0.1 mg BAY1002670, oral administration, four tablets to be taken daily, 84 consecutive days
BAY1002670 [1.0mg]	BAY1002670	1.0 mg BAY1002670, oral administration, four tablets to be taken daily, 84 consecutive days
BAY1002670 [2.0mg]	BAY1002670	2.0 mg BAY1002670, oral administration, four tablets to be taken daily, 84 consecutive days
BAY1002670 [5.0mg]	BAY1002670	5.0 mg BAY1002670, oral administration, four tablets to be taken daily, 84 consecutive days
Placebo	Placebo	Placebo for BAY1002670, oral administration, four tablets to be taken daily, 84 consecutive days

Primary Outcome Measures

Name	Time	Method
Non-bleeding rate (i.e. women without bleeding from treatment day 9 until the end of treatment)	After three months

Secondary Outcome Measures

Name	Time	Method
Return of menstrual bleeding after treatment	Up to two months after last treatment