Overview

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

Status:
Completed

Trial end date:
2007-12-01

Target enrollment:

Participant gender:

Summary

Efficacy and safety studies in the past have suggested that a starting dose of 75 International Unit (IU) of SJ-0021, and an increase in the dose by 37.5 IU every 7 days, are safe for treatment of subjects with ovulatory disorders who are infertile due to hypothalamic or pituitary dysfunction and have amenorrhea I or anovulatory cycles (including oligomenorrhea and polymenorrhea). This was a phase III, multicentre, single-blind, parallel-group comparative study conducted to provide confirmatory evidence of non-inferiority of SJ-0021 versus purified gonadotropin, a comparator drug, for induction of follicle development and ovulation in infertile Japanese women and to provide further information on the safety and tolerability of SJ-0021.

Phase:

Phase 3

Details

Lead Sponsor:

Merck KGaA
Merck KGaA, Darmstadt, Germany

Collaborator:

Merck Serono Co., Ltd., Japan

Treatments:

Follicle Stimulating Hormone
Gonadotropins, Pituitary
Hormones