Trial Condition(s):

Leiomyoma

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

Bayer Identifier:

14723

ClinicalTrials.gov Identifier:

NCT01816815

EudraCT Number:

2011-001760-22

Study Completed

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

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
73
Trial Dates
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Phase
1
Could I receive a placebo?
Yes
Products
Vilaprisan (BAY1002670)
Accepts Healthy Volunteers
Yes

Where to Participate

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Locations
Status
LocationsStatus
Locations

Bayer Pharma AG

Berlin, Germany, 13353

Status
Completed
 
Locations

Nuvisan GmbH

Neu-Ulm, Germany, 89231

Status
Completed
 
Locations

Focus Clinical Drug Development GmbH

Neuss, Germany, 41450

Status
Completed
 
Locations

BioKinetic Europe Ltd

Belfast, United Kingdom, BT2 7BA

Status
Completed
 
Locations

ZNA Stuivenberg

ANTWERPEN, Belgium, 2060

Status
Completed
 
Locations

Charité Research Organisation GmbH

Berlin, Germany, 10117

Status
Completed
 

Trial Design