Trial · NCT01185782
SJ-0021 (Gonalef®) Versus Purified Pituitary Gonadotropin (Fertinorm-P®) for Ovulation Induction in Japanese Infertile Women
NCT01185782, Phase 3, Completed, Merck KGaA, Darmstadt, Germany; results first posted 2012-02-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. SJ-0021 (Gonalef®) Versus Purified Pituitary Gonadotropin (Fertinorm-P®) for Ovulation Induction in Japanese Infertile Women. Trials, record NCT01185782. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01185782
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- SJ-0021 (Gonalef®) Versus Purified Pituitary Gonadotropin (Fertinorm-P®) for Ovulation Induction in Japanese Infertile Women
- NCT number
- NCT01185782
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 300 participants, actual
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Conditions
- Infertility, Ovulation Induction
- Interventions
- Gonalef® (Follitropin alfa), Purified pituitary gonadotropin (Fertinorm-P®)
- First posted
- 2010-08-20
- Last updated
- 2013-12-27
- Results first posted
- 2012-02-24
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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. |
| Secondary | Number of Participants With the Dominant Follicle Achieving 18 mm in Mean Diameter | Start of treatment period until Day 1 of post-treatment assessment period | |
| Secondary | Time for Dominant Follicle to Achieve 18 mm in Mean Diameter | 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. |
| Secondary | Total Dose of the Investigational Medicinal Product (IMP) Administered to Participants With Dominant Follicle Achieving 18 mm in Mean Diameter | 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. |
| Secondary | Human Chorionic Gonadotropin (hCG) Cancellation Rate | 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. |
| Secondary | Single Follicle Maturation Rate | 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. |
| Secondary | Biochemical Pregnancy Rate | 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 |
| Secondary | Clinical Pregnancy Rate | 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. |
| Secondary | Ovulation Rate, Where Ovulation is Defined as a Serum P4 Level Greater Than or Equal to 10 ng/mL or Clinical Pregnancy | 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. |
| Secondary | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and AEs Leading to Study Drug Discontinuation | 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. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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)] | Full analysis set (FAS) included all participants who received at least 1 dose of IMP and had no major violation of Good Clinical Practice (GCP) such as non-compliance with the agreement, serious protocol violations, etc. | percentage of participants | NUMBER |
| SECONDARY | Number of Participants With the Dominant Follicle Achieving 18 mm in Mean Diameter | Start of treatment period until Day 1 of post-treatment assessment period | FAS included all participants who received at least 1 dose of IMP and had no major violation of GCP such as non-compliance with the agreement, serious protocol violations, etc. | participants | NUMBER |
| SECONDARY | Time for Dominant Follicle to Achieve 18 mm in Mean Diameter | Start of treatment period until Day 1 of post-treatment assessment period | FAS included all participants who received at least 1 dose of IMP and had no major violation of GCP such as non-compliance with the agreement, serious protocol violations, etc. Only participants in whom the dominant follicle reached 18 mm in mean diameter were considered for the analysis. | days | MEAN |
| SECONDARY | Total Dose of the Investigational Medicinal Product (IMP) Administered to Participants With Dominant Follicle Achieving 18 mm in Mean Diameter | Start of treatment period until Day 1 of post-treatment assessment period | FAS included all participants who received at least 1 dose of IMP and had no major violation of GCP such as non-compliance with the agreement, serious protocol violations, etc. Only participants in whom the dominant follicle reached 18 mm in mean diameter were considered for the analysis of this parameter. | IU | MEAN |
| SECONDARY | Human Chorionic Gonadotropin (hCG) Cancellation Rate | Day 1 of post-treatment assessment period | FAS included all participants who received at least 1 dose of IMP and had no major violation of GCP such as non-compliance with the agreement, serious protocol violations, etc. | percent hCG cancellation | NUMBER |
| SECONDARY | Single Follicle Maturation Rate | Start of treatment period until Day 1 of post-treatment assessment period | FAS included all participants who received at least 1 dose of IMP and had no major violation of GCP such as non-compliance with the agreement, serious protocol violations, etc. | percent single follicle maturation | NUMBER |
| SECONDARY | Biochemical Pregnancy Rate | Day 28-31 of post-treatment assessment period | FAS included all participants who received at least 1 dose of IMP and had no major violation of GCP such as non-compliance with the agreement, serious protocol violations, etc. | percent biochemical pregnancy | NUMBER |
| SECONDARY | Clinical Pregnancy Rate | Day 35-42 of post-treatment assessment period | FAS included all participants who received at least 1 dose of IMP and had no major violation of GCP such as non-compliance with the agreement, serious protocol violations, etc. | percent clinical pregnancy | NUMBER |
| SECONDARY | Ovulation Rate, Where Ovulation is Defined as a Serum P4 Level Greater Than or Equal to 10 ng/mL or Clinical Pregnancy | On Day 6±1 or 9±1 during post-treatment assessment period | FAS included all participants who received at least 1 dose of IMP and had no major violation of GCP such as non-compliance with the agreement, serious protocol violations, etc. | percent ovulation | NUMBER |
| SECONDARY | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and AEs Leading to Study Drug Discontinuation | Pretrial observation period to post-treatment assessment period (Days 35-42) | Safety population included all participants who received at least 1 dose of IMP. This was actually identical to the FAS population. | participants | NUMBER |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group26
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Ovulation | SJ-0021 | 79.1 | percentage of participants | ||
| Percentage of Participants With Ovulation | u-hFSH | 82.6 | percentage of participants | ||
| Number of Participants With the Dominant Follicle Achieving 18 mm in Mean Diameter | SJ-0021 | 117 | participants | ||
| Number of Participants With the Dominant Follicle Achieving 18 mm in Mean Diameter | u-hFSH | 125 | participants | ||
| Time for Dominant Follicle to Achieve 18 mm in Mean Diameter | SJ-0021 | 13.1 | Standard Deviation 5.1 | days | |
| Time for Dominant Follicle to Achieve 18 mm in Mean Diameter | u-hFSH | 12.1 | Standard Deviation 4.2 | days | |
| Total Dose of the Investigational Medicinal Product (IMP) Administered to Participants With Dominant Follicle Achieving 18 mm in Mean Diameter | SJ-0021 | 959.29 | Standard Deviation 533.32 | IU | |
| Total Dose of the Investigational Medicinal Product (IMP) Administered to Participants With Dominant Follicle Achieving 18 mm in Mean Diameter | u-hFSH | 845.70 | Standard Deviation 432.88 | IU | |
| Human Chorionic Gonadotropin (hCG) Cancellation Rate | SJ-0021 | 7.0 | percent hCG cancellation | ||
| Human Chorionic Gonadotropin (hCG) Cancellation Rate | u-hFSH | 7.6 | percent hCG cancellation |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | SJ-0021 | 129 | |
| Overall Study | STARTED | u-hFSH | 136 | |
| Overall Study | Treated | SJ-0021 | 129 | |
| Overall Study | Treated | u-hFSH | 132 | |
| Overall Study | COMPLETED | SJ-0021 | 123 | |
| Overall Study | COMPLETED | u-hFSH | 125 | |
| Overall Study | NOT COMPLETED | SJ-0021 | 6 | |
| Overall Study | NOT COMPLETED | u-hFSH | 11 |
Source ClinicalTrials.gov
Adverse events14
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal pain lower | Gastrointestinal disorders | SJ-0021 | 6 | 129 | 7 |
| other | Abdominal pain lower | Gastrointestinal disorders | u-hFSH | 14 | 132 | 17 |
| other | Abdominal distension | Gastrointestinal disorders | SJ-0021 | 9 | 129 | 10 |
| other | Abdominal distension | Gastrointestinal disorders | u-hFSH | 7 | 132 | 7 |
| other | Ascites | Gastrointestinal disorders | SJ-0021 | 4 | 129 | 4 |
| other | Ascites | Gastrointestinal disorders | u-hFSH | 7 | 132 | 7 |
| other | Nasopharyngitis | Infections and infestations | SJ-0021 | 10 | 129 | 10 |
| other | Nasopharyngitis | Infections and infestations | u-hFSH | 11 | 132 | 11 |
| other | Headache | Nervous system disorders | SJ-0021 | 6 | 129 | 6 |
| other | Headache | Nervous system disorders | u-hFSH | 8 | 132 | 9 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | SJ-0021 | ||
| Total, all-cause mortality | u-hFSH | ||
| Total, other adverse events | SJ-0021 | 36 | 129 |
| Total, other adverse events | u-hFSH | 40 | 132 |
| Total, serious adverse events | SJ-0021 | 1 | 129 |
| Total, serious adverse events | u-hFSH | 1 | 132 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 29699333 | RESULT |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| SJ-0021 vs u-hFSH: Number of Participants With the Dominant Follicle Achieving 18 mm in Mean Diameter | Trial comparisons |
| SJ-0021 vs u-hFSH: Number of Participants With OHSS | Trial comparisons |
| SJ-0021 vs u-hFSH: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01185782
GET https://conductscience.org/api/trials/v1/NCT01185782/results?page=2