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: 0
• Participant gender: Female

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck KGaA; Merck KGaA, Darmstadt, Germany
• Collaborator: Merck Serono Co., Ltd., Japan
• Treatments: Follicle Stimulating Hormone; Gonadotropins, Pituitary; Hormones

Criteria

Inclusion Criteria:

• Women aged 20 to 39 years (inclusive) who hope to bear children

• Subjects who failed to achieve ovulation or pregnancy despite 2 cycles or more of anti-estrogen therapies (clomiphene citrate, cyclofenil, etc.)

• Subjects who exhibited withdrawal bleeding in a progesterone test (Includes spontaneous menstruation in subjects with anovulatory cycles.)

• Subjects having a body mass index between 17.0 and 28.0 at the time of baseline tests

• Subjects who voluntarily consented in writing to participate in the clinical trial

Exclusion Criteria:

• Subjects with ovarian tumors

• Subjects with ovarian enlargement not due to PCOS

• Subjects with genitourinary hemorrhage of unknown cause

• Subjects who were or may be pregnant, or who were lactating

• Subjects with history of allergic reaction or hypersensitivity to gonadotropin

• Subjects with dysfunction of heart, lungs, kidneys, or cardiovascular systems of Grade 2 or higher (in compliance with the Pharmaceutical and Medical Safety Bureau Notification Yakuan No. 80 [issued 29 June 1992])

• Subjects with serum progesterone (P4) level ≥ 5 ng/mL in baseline tests

• Subjects with malignant tumors

• Subjects with uterine amenorrhea

• Subjects with elevated levels of serum gonadotropin due to premature ovarian failure (FSH ≥ 20 mIU/mL)

• Subjects who were infertile due to known adrenal or thyroid dysfunction

• Subjects who were diagnosed as having hyperprolactinemia

• Subjects who had been documented or suspected of having intracranial lesions (e.g., pituitary tumors)

• Infertile subjects involving gynecological factors other than amenorrhea I or anovulatory cycles, and for whom ovulation induction therapy was found to be contraindicated

• Subjects who had participated in another clinical study within 6 months prior to start of the IMP administration

• Subjects who had been administered SJ-0021 in the past

• Subjects whose participation in this clinical trial was otherwise deemed inappropriate by the investigator or sub-investigator