A Study in Healthy Female Participants Investigating the Effect of TMC435 on the Pharmacokinetics of the Synthetic Hormones of the Oral Contraceptive Ovysmen

PHASE1CompletedINTERVENTIONAL
Enrollment

18

Participants

Timeline

Start Date

November 30, 2011

Primary Completion Date

January 31, 2012

Study Completion Date

January 31, 2012

Conditions
Hepatitis C Virus
Interventions
DRUG

TMC435

Type = exact number, unit = mg, number = 150, form = capsule, route = oral use. Capsule is taken once daily for 10 days (Day12 till and including Day21) in 2nd OC cycle.

DRUG

Ovysmen

Type = exact number, unit = mg, number = 35µg/1mg, form = tablet, route = oral use. 35 µg ethinylestradiol and 1 mg norethindrone once daily for first 21 days in each OC cycle (2 OC cycles in total)

Trial Locations (1)

Unknown

Merksem

All Listed Sponsors
lead

Tibotec Pharmaceuticals, Ireland

INDUSTRY

NCT01486004 - A Study in Healthy Female Participants Investigating the Effect of TMC435 on the Pharmacokinetics of the Synthetic Hormones of the Oral Contraceptive Ovysmen | Biotech Hunter | Biotech Hunter