SJ-0021 (Gonalef®) Versus Purified Pituitary Gonadotropin (Fertinorm-P®) for Ovulation Induction in Japanese Infertile Women
Condition: Infertility; Ovulation Induction
MeSH terms: Pituitary Diseases; Infertility
Intervention: Gonalef® (Follitropin alfa); Purified pituitary gonadotropin (Fertinorm-P®)
Intervention description: 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.; 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.
Intervention MeSH terms: Gonadotropins, Pituitary; Hormones; Follicle Stimulating Hormone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 300.0
Sex: Female
Minimum age: 20 Years
Maximum age: 39 Years
Healthy volunteers: No
Keywords: Infertility; Ovulation induction; Gonalef® (Follitropin alfa); Purified pituitary gonadotropin (Fertinorm-P®); gonadotropin; Reproductive technologies, assisted; Polycystic ovary syndrome

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.
    

Eligibility 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