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:
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