Phase 3
N=265
SJ-0021 (Gonalef®) Versus Purified Pituitary Gonadotropin (Fertinorm-P®) for Ovulation Induction in Japanese Infertile Women
Infertility · Ovulation Induction
Bottom Line
View on ClinicalTrials.gov: NCT01185782 ↗Enrolled (actual)
265
Serious AEs
0.8%
Results posted
Feb 2012
Primary outcome: Primary: Percentage of Participants With Ovulation — 79.1; 82.6 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Gonalef® (Follitropin alfa) (Drug); Purified pituitary gonadotropin (Fertinorm-P®) (Drug)
- Age
- Adult · 20+ yrs
- Sex
- Female
- Sponsor
- Merck KGaA, Darmstadt, Germany
- Primary completion
- Dec 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Ovulation |
79.1; 82.6 | — |
| SECONDARY Number of Participants With the Dominant Follicle Achieving 18 mm in Mean Diameter |
117; 125 | 0.214 |
| SECONDARY Time for Dominant Follicle to Achieve 18 mm in Mean Diameter |
13.1; 12.1 | 0.087 |
| SECONDARY Total Dose of the Investigational Medicinal Product (IMP) Administered to Participants With Dominant Follicle Achieving 18 mm in Mean Diameter |
959.29; 845.70 | 0.069 |
| SECONDARY Human Chorionic Gonadotropin (hCG) Cancellation Rate |
7.0; 7.6 | 0.852 |
| SECONDARY Single Follicle Maturation Rate |
33.3; 43.2 | 0.102 |
| SECONDARY Biochemical Pregnancy Rate |
17.8; 15.2 | 0.560 |
| SECONDARY Clinical Pregnancy Rate |
17.1; 14.4 | 0.555 |
| SECONDARY Ovulation Rate, Where Ovulation is Defined as a Serum P4 Level Greater Than or Equal to 10 ng/mL or Clinical Pregnancy |
71.3; 75.8 | 0.416 |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and AEs Leading to Study Drug Discontinuation |
69; 66; 1; 1; 0; 1 | — |
| SECONDARY Number of Participants With OHSS |
10; 5 | — |
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
Data sourced from ClinicalTrials.gov (NCT01185782). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.