Clinical trial · Interventional
SJ-0021 (Gonalef®) Versus Purified Pituitary Gonadotropin (Fertinorm-P®) for Ovulation Induction in Japanese Infertile Women
Parallel-Group Comparative Study of SJ-0021 and Purified Pituitary Gonadotropin in Subjects With Amenorrhea I or Anovulatory Cycles - Phase III Single-Blind Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Infertility | — | UNRESOLVED | — |
| Ovulation Induction | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gonalef® (Follitropin alfa) | Drug | — | UNRESOLVED |
| Purified pituitary gonadotropin (Fertinorm-P®) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- SJ-0021 group
- interventionNames
- Drug: Gonalef® (Follitropin alfa)
- type
- ACTIVE_COMPARATOR
- label
- Purified pituitary gonadotropin group
- interventionNames
- Drug: Purified pituitary gonadotropin (Fertinorm-P®)
Primary outcomes (1)
- measure
- Percentage of Participants With Ovulation
- timeFrame
- On Day 6±1 or 9±1 days during post-treatment assessment period (Day 35-42 of post-treatment period for clinical pregnancy)]
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 39 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTTaketani Y, Kelly E, Yoshimura Y, Hoshiai H, Irahara M, Mizunuma H, Saito H, Andoh K, Yanaihara T. Recombinant follicle-stimulating hormone (follitropin alfa) versus purified urinary follicle-stimulating hormone in a low-dose step-up regimen to induce ovulation in Japanese women with anti-estrogen-ineffective oligo- or anovulatory infertility: results of a single-blind Phase III study. Reprod Med Biol. 2010 Feb 23;9(2):99-106. doi: 10.1007/s12522-010-0046-5. eCollection 2010 Jun. PMID 29699333