E4/DRSP Single and Multiple Dose PK and Early QT Study

PHASE1CompletedINTERVENTIONAL
Enrollment

55

Participants

Timeline

Start Date

May 31, 2016

Primary Completion Date

November 21, 2016

Study Completion Date

November 21, 2016

Conditions
Contraception
Interventions
DRUG

15 mg E4/3 mg DRSP

a single oral dose of 15 mg E4/3 mg DRSP (n=10) followed, after a washout of at least 14 days, by multiple oral doses of 15 mg E4/3 mg DRSP (n=10) once daily for 14 days

DRUG

30 mg E4/6 mg DRSP

a single oral dose of 30 mg E4/6 mg DRSP, followed, after a washout of at least 14 days, by multiple oral doses of 30 mg E4/6 mg DRSP once daily for 14 days

DRUG

60 mg E4/12 mg DRSP

a single oral dose of 60 mg E4/12 mg DRSP, followed, after a washout of at least 14 days, by oral doses of 60 mg E4/12 mg DRSP once daily for 14 days

DRUG

Visually matching placebo

a single oral dose of a placebo which visually matches the active medication, followed, after a washout of at least 14 days, by multiple oral doses of matching placebo once daily for 14 days

DRUG

75 mg E4/15 mg DRSP

a single oral dose of 75 mg E4/15 mg DRSP, followed, after a washout of at least 14 days, by oral doses of 75 mg E4/15 mg DRSP once daily for 14 days

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Estetra

INDUSTRY