Trial Condition(s):

Clinical Trial, Phase I

Study in postmenopausal women to investigate the Drug-drug interaction (DDI) between itraconazole(ITZ) and orally administered vilaprisan; absolute bioavailability using intravenous microtracer dose of [14C]vilaprisan

Bayer Identifier:

15250

ClinicalTrials.gov Identifier:

NCT02456129

EudraCT Number:

2014-004929-41

Study Completed

Trial Purpose

This is a study in postmenopausal women to investigate
the Drug-drug interaction (DDI) between
itraconazole(ITZ) and orally administered vilaprisan;
absolute bioavailability using intravenous microtracer
dose of [14C]vilaprisan.

Inclusion Criteria
- Body mass index (BMI): 18 ≤ BMI ≤ 32 kg/m²
- Postmenopausal state revealed by:
Medical history, if applicable (natural menopause at
least 12 months prior to first study drug administration;
or surgical menopause by bilateral ovariectomy at least
3 months prior to first study drug administration),
in addition: in women < 65 years old, follicle stimulating
hormone (FSH) > 40 IU/L
Exclusion Criteria
- Incompletely cured pre-existing diseases for which it
can be assumed that the absorption, distribution,
metabolism, elimination or effects of the study drugs will
not be normal
- Known or suspected liver diseases
- Clinically relevant findings(e.g. blood pressure,
electrocardiogram(ECG); physical and  gynecological
examination, laboratory examination)

Trial Summary

Enrollment Goal
14
Trial Dates
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Phase
1
Could I receive a placebo?
No
Products
Vilaprisan (BAY1002670)
Accepts Healthy Volunteers
Yes

Where to Participate

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Locations
Status
LocationsStatus
Locations

Covance Clinical Research Unit

Leeds, United Kingdom, LS2 9LH

Status
Completed
 

Trial Design