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Parallel-Group Comparative Study of SJ-0021 and Purified Pituitary Gonadotropin in Subjects With Amenorrhea I or Anovulatory Cycles - Phase III Single-Blind Study
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.
Details
| Lead sponsor | Merck KGaA, Darmstadt, Germany |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 300 |
| Start date | 2007-02 |
| Completion | 2007-12 |
Conditions
- Infertility
- Ovulation Induction
Interventions
- Gonalef® (Follitropin alfa)
- Purified pituitary gonadotropin (Fertinorm-P®)
Primary outcomes
- Percentage of Participants With Ovulation — On Day 6±1 or 9±1 days during post-treatment assessment period (Day 35-42 of post-treatment period for clinical pregnancy)]
Participants were considered to have ovulated if serum progesterone (P4) level was greater than or equal to 5 nanogram (ng)/mL on Day 6±1 or 9±1 during the post-treatment assessment period, or if the participant became clinically pregnant.
Countries
Japan