Bioequivalence Trial of Liquid Versus Freeze-Dried Pergoveris® in Pituitary Suppressed Healthy Premenopausal Female Subjects

PHASE1CompletedINTERVENTIONAL
Enrollment

34

Participants

Timeline

Start Date

January 31, 2015

Primary Completion Date

October 31, 2015

Study Completion Date

October 31, 2015

Conditions
Healthy
Interventions
DRUG

Liquid pergoveris

All subjects will be administered with 900 IU of r-hFSH and 450 IU of r-hLH solution (Liquid Pergoveris) as subcutaneous injection using a disposable pen-injector on Day 1 in either first intervention period or second intervention period.

DRUG

Freeze-dried pergoveris

All subjects will be administered with 900 IU of r-hFSH and 450 IU of r-hLH freeze-dried powder (Freeze-dried Pergoveris) as subcutaneous injection on Day 1 in either first intervention period or second intervention period.

Trial Locations (1)

Unknown

Please contact the Merck KGaA Communication Center, Darmstadt

All Listed Sponsors
lead

Merck KGaA, Darmstadt, Germany

INDUSTRY

NCT02317809 - Bioequivalence Trial of Liquid Versus Freeze-Dried Pergoveris® in Pituitary Suppressed Healthy Premenopausal Female Subjects | Biotech Hunter | Biotech Hunter