"E4/DRSP Endocrine Function, Metabolic Control and Hemostasis Study"

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

101

Participants

Timeline

Start Date

September 30, 2016

Primary Completion Date

October 9, 2017

Study Completion Date

October 9, 2017

Conditions
ContraceptionLiver MetabolismHemostasis Parameter
Interventions
DRUG

15 mg E4/3 mg DRSP

15 mg E4 combined with 3 mg DRSP administered in a 24/4-day regimen (i.e. 24 days of pink active tablets followed by 4 days of white placebo tablets). One tablet per day orally for 6 treatment cycles.

DRUG

30 mcg EE/150 mcg LNG

30 mcg EE combined with 150 mcg LNG administered in a 21/7-day regimen (i.e. 21 days of yellow active tablets followed by 7 days of white placebo tablets). One tablet per day orally for 6 treatment cycles.

DRUG

20 mcg EE/3 mg DRSP

20 mcg EE combined with 3 mg DRSP administered in a 24/4-day regimen (i.e. 24 days of pink active tablets followed by 4 days of white placebo tablets). One tablet per day orally for 6 treatment cycles.

Trial Locations (1)

9713 GZ

Dinox BV, Groningen

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Estetra

INDUSTRY