SJ-0021 (Gonalef®) Versus Purified Pituitary Gonadotropin (Fertinorm-P®) for Ovulation Induction in Japanese Infertile Women
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|ClinicalTrials.gov Identifier: NCT01185782|
Recruitment Status : Completed
First Posted : August 20, 2010
Results First Posted : February 24, 2012
Last Update Posted : December 27, 2013
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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.
|Condition or disease||Intervention/treatment||Phase|
|Infertility Ovulation Induction||Drug: Gonalef® (Follitropin alfa) Drug: Purified pituitary gonadotropin (Fertinorm-P®)||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Parallel-Group Comparative Study of SJ-0021 and Purified Pituitary Gonadotropin in Subjects With Amenorrhea I or Anovulatory Cycles - Phase III Single-Blind Study|
|Study Start Date :||February 2007|
|Actual Primary Completion Date :||December 2007|
|Actual Study Completion Date :||December 2007|
|Experimental: SJ-0021 group||
Drug: Gonalef® (Follitropin alfa)
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.
|Active Comparator: Purified pituitary gonadotropin group||
Drug: Purified pituitary gonadotropin (Fertinorm-P®)
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.
- Percentage of Participants With Ovulation [ Time Frame: 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.
- Number of Participants With the Dominant Follicle Achieving 18 mm in Mean Diameter [ Time Frame: Start of treatment period until Day 1 of post-treatment assessment period ]
- Time for Dominant Follicle to Achieve 18 mm in Mean Diameter [ Time Frame: Start of treatment period until Day 1 of post-treatment assessment period ]Dosing time length was calculated as number of days from the first administration of the IMP until the mean diameter of the dominant follicle was confirmed to have reached 18 mm.
- Total Dose of the Investigational Medicinal Product (IMP) Administered to Participants With Dominant Follicle Achieving 18 mm in Mean Diameter [ Time Frame: Start of treatment period until Day 1 of post-treatment assessment period ]Total dose of IMP administered was defined as the cumulative dose administered from the start of treatment with IMP until the mean diameter of the dominant follicle reached 18 mm.
- Human Chorionic Gonadotropin (hCG) Cancellation Rate [ Time Frame: Day 1 of post-treatment assessment period ]hCG cancellation criterion was defined as the presence of 4 or more ovarian follicles with a mean diameter greater than or equal to 16 mm. If the hCG cancellation criterion was met, the administration of hCG was withheld. Otherwise, a single intramuscular dose of hCG 5000 IU (Japanese Pharmacopoeia- JP) was administered within 24 hours of the last ultrasound examination.
- Single Follicle Maturation Rate [ Time Frame: Start of treatment period until Day 1 of post-treatment assessment period ]Single follicle maturation was defined as the presence of the dominant follicle with a mean diameter of 18 mm or greater without concurrent presence of other follicles of 14 mm or larger in diameter.
- Biochemical Pregnancy Rate [ Time Frame: Day 28-31 of post-treatment assessment period ]Biochemical pregnancy was defined as a positive pregnancy test (urinary beta-hCG test) on Day 28-31 of the post-treatment assessment period
- Clinical Pregnancy Rate [ Time Frame: Day 35-42 of post-treatment assessment period ]Clinical pregnancy was defined as existence of at least one ultrasonography confirmed gestational sac in the uterus, with or without heartbeat.
- Ovulation Rate, Where Ovulation is Defined as a Serum P4 Level Greater Than or Equal to 10 ng/mL or Clinical Pregnancy [ Time Frame: On Day 6±1 or 9±1 during post-treatment assessment period ]For this secondary endpoint, participants were considered to have ovulated if serum P4 level was more than or equal to 10 ng/mL on Day 6±1 or 9±1 during the post-treatment assessment period, or if the participant became clinically pregnant.
- Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and AEs Leading to Study Drug Discontinuation [ Time Frame: Pretrial observation period to post-treatment assessment period (Days 35-42) ]AEs: Any untoward medical occurrence in the form of signs, clinically significant abnormalities in laboratory findings, diseases, symptoms, or worsening of complications. TEAEs: AEs that occur during treatment with the IMP. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was a medically important condition. Participants who discontinued from the study due to AE were also recorded.
- Number of Participants With OHSS [ Time Frame: Start of treatment period to post-treatment assessment period (Day 35-42) ]OHSS is a syndrome which can manifest with enlarged ovaries, advanced ascites with increased vascular permeability, pleural fluid accumulation, hemoconcentration, and increased blood clotting.
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|Ages Eligible for Study:||20 Years to 39 Years (Adult)|
|Sexes Eligible for Study:||Female|
|Accepts Healthy Volunteers:||No|
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01185782
|The University of Tokyo Hospital|
|Study Director:||Kimitoshi Takemura||Merck Serono Co., Ltd., Japan|
|Responsible Party:||Merck KGaA, Darmstadt, Germany|
|Other Study ID Numbers:||
|First Posted:||August 20, 2010 Key Record Dates|
|Results First Posted:||February 24, 2012|
|Last Update Posted:||December 27, 2013|
|Last Verified:||December 2013|
Gonalef® (Follitropin alfa)
Purified pituitary gonadotropin (Fertinorm-P®)
Reproductive technologies, assisted
Polycystic ovary syndrome
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Follicle Stimulating Hormone
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Fertility Agents, Female
Reproductive Control Agents
Fertility Agents, Male