The Safety and Pharmacokinetics of Primapur and Gonal-f

PHASE1CompletedINTERVENTIONAL
Enrollment

28

Participants

Timeline

Start Date

October 29, 2015

Primary Completion Date

May 10, 2016

Study Completion Date

May 10, 2016

Conditions
Area Under CurvePharmacokineticsAbsorption
Interventions
DRUG

Follitropin alfa (Primapur)

"During the crossover pharmacokinetic phase, after 42 days of combined oral contraceptive (ethinylestradiol and drospirenone) administration subjects with endogenous level of follicle stimulating hormone (FSH) less than 5 IU/l were randomly assigned to receive one of the following treatment sequences:~Sequence A: Single subcutaneous injection of 300 IU Primapur on study day 1, after 10 days of wash out a single subcutaneous injection of 300 IU Gonal-F.~Sequence B: Single subcutaneous injection of 300 IU US Gonal-F on study day 1, after 10 days of wash out a single subcutaneous injection of 300 IU Primapur."

DRUG

Follitropin alfa (Gonal-F)

"During the crossover pharmacokinetic phase, after 42 days of combined oral contraceptive (ethinylestradiol and drospirenone) administration subjects with endogenous level of follicle stimulating hormone (FSH) less than 5 IU/l were randomly assigned to receive one of the following treatment sequences:~Sequence A: Single subcutaneous injection of 300 IU Primapur on study day 1, after 10 days of wash out a single subcutaneous injection of 300 IU Gonal-F.~Sequence B: Single subcutaneous injection of 300 IU US Gonal-F on study day 1, after 10 days of wash out a single subcutaneous injection of 300 IU Primapur."

Trial Locations (1)

Unknown

O.M. Filatov Municipal Clinical Hospital N 15, Moscow

All Listed Sponsors
collaborator

NADIM LLC

UNKNOWN

lead

IVFarma LLC

INDUSTRY

NCT03857230 - The Safety and Pharmacokinetics of Primapur and Gonal-f | Biotech Hunter | Biotech Hunter