check_circleStudy Completed
Leiomyoma
Bayer Identifier:
14723
ClinicalTrials.gov Identifier:
EudraCT Number:
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
FemaleAge
18 - 45 YearsTrial summary
Enrollment Goal
73Trial Dates
November 2011 - January 2013Phase
Phase 1Could I Receive a placebo
YesProducts
Vilaprisan (BAY1002670)Accepts Healthy Volunteer
YesWhere 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)date_rangeTime Frame:After three monthsenhanced_encryptionNoSafety Issue:
Secondary Outcome
- Return of menstrual bleeding after treatmentdate_rangeTime Frame:Up to two months after last treatmentenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
OtherAllocation
RandomizedBlinding
Double BlindAssignment
Parallel AssignmentTrial Arms
6