Study Completed

Leiomyoma

Bayer Identifier:

14723

ClinicalTrials.gov Identifier:

NCT01816815

EudraCT Number:

2011-001760-22

EU CT Number:

Not Available

Study in healthy tubal ligated women to evaluate pharmacodynamics, safety and pharmacokinetics of BAY1002670

Trial purpose

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

Key Participants Requirements

Sex

Female

Age

18 - 45 Years

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)

Trial summary

Enrollment Goal

Trial Dates

November 2011 - January 2013

Phase

Phase 1

Could I Receive a placebo

Yes

Products

Vilaprisan (BAY1002670)

Accepts Healthy Volunteer

Yes

Where to participate

Status	Institution	Location
Completed	Bayer Pharma AG	Berlin, 13353, Germany
Completed	Nuvisan GmbH	Neu-Ulm, 89231, Germany
Completed	Focus Clinical Drug Development GmbH	Neuss, 41450, Germany
Completed	BioKinetic Europe Ltd	Belfast, BT2 7BA, United Kingdom
Completed	ZNA Stuivenberg	ANTWERPEN, 2060, Belgium
Completed	Charité Research Organisation GmbH	Berlin, 10117, Germany

Primary Outcome

Non-bleeding rate (i.e. women without bleeding from treatment day 9 until the end of treatment)
Time Frame:
After three months
Safety Issue:
No

Secondary Outcome

Return of menstrual bleeding after treatment
Time Frame:
Up to two months after last treatment
Safety Issue:
No

Trial design

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

Trial Type

Interventional

Intervention Type

Drug

Trial Purpose

Other

Allocation

Randomized

Blinding

Double Blind

Assignment

Parallel Assignment

Trial Arms

Additional Information

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