SJ-0021 (Gonalef®) Versus Purified Pituitary Gonadotropin (Fertinorm-P®) for Ovulation Induction in Japanese Infertile Women

PHASE3CompletedINTERVENTIONAL
Enrollment

300

Participants

Timeline

Start Date

February 28, 2007

Primary Completion Date

December 31, 2007

Study Completion Date

December 31, 2007

Conditions
InfertilityOvulation Induction
Interventions
DRUG

Gonalef® (Follitropin alfa)

Subcutaneous administration of follitropin alfa at a dose of 75 IU/day was started on dosing Day 1 and the same daily dose was maintained for the first 7 days of the treatment period. Dose increment by 37.5 IU was permitted on dosing Day 8, Day 15 and Day 22 if the dosage increase criterion was met.

DRUG

Purified pituitary gonadotropin (Fertinorm-P®)

Subcutaneous administration of purified pituitary gonadotropin at a dose of 75 IU/day was started on dosing Day 1 and the same daily dose was maintained for the first 7 days of the treatment period. Dose increment by 37.5 IU was permitted on dosing Day 8, Day 15 and Day 22 if the dosage increase criterion was met.

Trial Locations (1)

Unknown

The University of Tokyo Hospital, Tokyo

All Listed Sponsors
collaborator

Merck Serono Co., Ltd., Japan

INDUSTRY

lead

Merck KGaA, Darmstadt, Germany

INDUSTRY

NCT01185782 - SJ-0021 (Gonalef®) Versus Purified Pituitary Gonadotropin (Fertinorm-P®) for Ovulation Induction in Japanese Infertile Women | Biotech Hunter | Biotech Hunter