Status:
COMPLETED
A Study in Healthy Female Participants Investigating the Effect of TMC435 on the Pharmacokinetics of the Synthetic Hormones of the Oral Contraceptive Ovysmen
Lead Sponsor:
Tibotec Pharmaceuticals, Ireland
Conditions:
Hepatitis C Virus
Eligibility:
FEMALE
18-45 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to investigate the effect of steady-state concentrations of TMC435 (administered once a day) on the steady-state pharmacokinetics of ethinylestradiol and norethindrone (ad...
Detailed Description
This is a Phase I, open-label (both participant and investigator know the name of the medication given at a certain moment) trial in 18 healthy female participants to investigate the effect of TMC435 ...
Eligibility Criteria
Inclusion
- Participants must practicing a highly effective method of birth control before entry and agree to continue to use the same method throughout the study and for at least 30 days after last administration of study drug
- non-smoker for a least 3 months prior to screening
Exclusion
- Women who are pregnant, breastfeeding, pre-menopausal or post-menopausal
- A positive Human Immunodeficiency Virus (HIV)-1 or HIV-2 test at screening
- A positive Hepatitis A, B and C test at screening
- A clinical significant abnormal finding in the gynaecological examination
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT01486004
Start Date
November 1 2011
End Date
January 1 2012
Last Update
January 31 2013
Active Locations (1)
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1
Merksem, Belgium