Status:
COMPLETED
SJ-0021 (Gonalef®) Versus Purified Pituitary Gonadotropin (Fertinorm-P®) for Ovulation Induction in Japanese Infertile Women
Lead Sponsor:
Merck KGaA, Darmstadt, Germany
Collaborating Sponsors:
Merck Serono Co., Ltd., Japan
Conditions:
Infertility
Ovulation Induction
Eligibility:
FEMALE
20-39 years
Phase:
PHASE3
Brief 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 sub...
Detailed Description
Follicle stimulating hormone (FSH) is a heterodimeric glycoprotein wherein an alfa subunit and a beta subunit are noncovalently bonded. Follicle stimulating hormone is one of the key hormones regulati...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT01185782
Start Date
February 1 2007
End Date
December 1 2007
Last Update
December 27 2013
Active Locations (1)
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1
The University of Tokyo Hospital
Tokyo, Japan