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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
Sponsor:
Collaborator:
Merck Serono Co., Ltd., Japan
Information provided by (Responsible Party):
Merck KGaA, Darmstadt, Germany

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Conditions Infertility
Ovulation Induction
Interventions Drug: Gonalef® (Follitropin alfa)
Drug: Purified pituitary gonadotropin (Fertinorm-P®)
Enrollment 300
Recruitment Details Participants were recruited in 21 study centers in Japan from 15 February 2007 to 25 December 2007.
Pre-assignment Details 300 participants were enrolled in the study; 39 participants discontinued prior to Investigational Medicinal Product (IMP) administration (35 participants for no longer meeting the eligibility criteria 4 due to Adverse Events [AEs] or other reasons). Demographic data was not available for the 4 participants who were randomized but not treated.
Arm/Group Title SJ-0021 u-hFSH
Hide Arm/Group Description SJ-0021 (recombinant follitropin alfa) was administered subcutaneously (s.c.) at a starting dose of 75 International Unit (IU)/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days. Urinary human follicle stimulating hormone (u-hFSH), a purified pituitary gonadotropin, was administered s.c. at a starting dose of 75 IU/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
Period Title: Overall Study
Started 129 136
Treated 129 132
Completed 123 125
Not Completed 6 11
Reason Not Completed
Adverse Event             0             1
Protocol Violation             1             0
Poor Response to Treatment             3             1
Other             2             5
Randomized but not treated             0             4
Arm/Group Title SJ-0021 u-hFSH Total
Hide Arm/Group Description SJ-0021 (recombinant follitropin alfa) was administered subcutaneously (s.c.) at a starting dose of 75 International Unit (IU)/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days. Urinary human follicle stimulating hormone (u-hFSH), a purified pituitary gonadotropin, was administered s.c. at a starting dose of 75 IU/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days. Total of all reporting groups
Overall Number of Baseline Participants 129 132 261
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 129 participants 132 participants 261 participants
31.6  (3.8) 31.6  (3.8) 31.6  (3.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 129 participants 132 participants 261 participants
Female
129
 100.0%
132
 100.0%
261
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Previous episodes of Ovarian hyperstimulation syndrome (OHSS)   [1] 
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 129 participants 132 participants 261 participants
0 116 119 235
1 9 10 19
2 2 3 5
3 1 0 1
4 1 0 1
[1]
Measure Description: OHSS is a syndrome which can manifest with enlarged ovaries, advanced ascites with increased vascular permeability, pleural fluid accumulation, hemoconcentration, and increased blood clotting. Episodes of OHSS are presented as values from 0 to 4 where 0 = no episodes to 4 = four episodes.
1.Primary Outcome
Title Percentage of Participants With Ovulation
Hide 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.
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)]
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title SJ-0021 u-hFSH
Hide Arm/Group Description:
SJ-0021 (recombinant follitropin alfa) was administered subcutaneously (s.c.) at a starting dose of 75 International Unit (IU)/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
Urinary human follicle stimulating hormone (u-hFSH), a purified pituitary gonadotropin, was administered s.c. at a starting dose of 75 IU/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
Overall Number of Participants Analyzed 129 132
Measure Type: Number
Unit of Measure: percentage of participants
79.1 82.6
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SJ-0021, u-hFSH
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments The primary endpoint was to determine whether or not SJ-0021 is inferior to u-hFSH in inducing ovulation. The criterion for non-inferiority was that the lower limit of the two-sided 95% CI (= one-sided 97.5% CI) had to be greater than -15% for SJ-0021 to be considered not inferior to u-hFSH.")
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Delta
Estimated Value -3.51
Confidence Interval (2-Sided) 95%
-13.05 to 6.04
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Number of Participants With the Dominant Follicle Achieving 18 mm in Mean Diameter
Hide Description [Not Specified]
Time Frame Start of treatment period until Day 1 of post-treatment assessment period
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title SJ-0021 u-hFSH
Hide Arm/Group Description:
SJ-0021 (recombinant follitropin alfa) was administered subcutaneously (s.c.) at a starting dose of 75 International Unit (IU)/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
Urinary human follicle stimulating hormone (u-hFSH), a purified pituitary gonadotropin, was administered s.c. at a starting dose of 75 IU/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
Overall Number of Participants Analyzed 129 132
Measure Type: Number
Unit of Measure: participants
117 125
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SJ-0021, u-hFSH
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.214
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
3.Secondary Outcome
Title Time for Dominant Follicle to Achieve 18 mm in Mean Diameter
Hide Description 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.
Time Frame Start of treatment period until Day 1 of post-treatment assessment period
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title SJ-0021 u-hFSH
Hide Arm/Group Description:
SJ-0021 (recombinant follitropin alfa) was administered subcutaneously (s.c.) at a starting dose of 75 International Unit (IU)/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
Urinary human follicle stimulating hormone (u-hFSH), a purified pituitary gonadotropin, was administered s.c. at a starting dose of 75 IU/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
Overall Number of Participants Analyzed 117 125
Mean (Standard Deviation)
Unit of Measure: days
13.1  (5.1) 12.1  (4.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SJ-0021, u-hFSH
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.087
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
4.Secondary Outcome
Title Total Dose of the Investigational Medicinal Product (IMP) Administered to Participants With Dominant Follicle Achieving 18 mm in Mean Diameter
Hide Description 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.
Time Frame Start of treatment period until Day 1 of post-treatment assessment period
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title SJ-0021 u-hFSH
Hide Arm/Group Description:
SJ-0021 (recombinant follitropin alfa) was administered subcutaneously (s.c.) at a starting dose of 75 International Unit (IU)/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
Urinary human follicle stimulating hormone (u-hFSH), a purified pituitary gonadotropin, was administered s.c. at a starting dose of 75 IU/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
Overall Number of Participants Analyzed 117 125
Mean (Standard Deviation)
Unit of Measure: IU
959.29  (533.32) 845.70  (432.88)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SJ-0021, u-hFSH
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.069
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
5.Secondary Outcome
Title Human Chorionic Gonadotropin (hCG) Cancellation Rate
Hide Description 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.
Time Frame Day 1 of post-treatment assessment period
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title SJ-0021 u-hFSH
Hide Arm/Group Description:
SJ-0021 (recombinant follitropin alfa) was administered subcutaneously (s.c.) at a starting dose of 75 International Unit (IU)/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
Urinary human follicle stimulating hormone (u-hFSH), a purified pituitary gonadotropin, was administered s.c. at a starting dose of 75 IU/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
Overall Number of Participants Analyzed 129 132
Measure Type: Number
Unit of Measure: percent hCG cancellation
7.0 7.6
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SJ-0021, u-hFSH
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.852
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
6.Secondary Outcome
Title Single Follicle Maturation Rate
Hide Description 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.
Time Frame Start of treatment period until Day 1 of post-treatment assessment period
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title SJ-0021 u-hFSH
Hide Arm/Group Description:
SJ-0021 (recombinant follitropin alfa) was administered subcutaneously (s.c.) at a starting dose of 75 International Unit (IU)/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
Urinary human follicle stimulating hormone (u-hFSH), a purified pituitary gonadotropin, was administered s.c. at a starting dose of 75 IU/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
Overall Number of Participants Analyzed 129 132
Measure Type: Number
Unit of Measure: percent single follicle maturation
33.3 43.2
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SJ-0021, u-hFSH
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.102
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
7.Secondary Outcome
Title Biochemical Pregnancy Rate
Hide Description Biochemical pregnancy was defined as a positive pregnancy test (urinary beta-hCG test) on Day 28-31 of the post-treatment assessment period
Time Frame Day 28-31 of post-treatment assessment period
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title SJ-0021 u-hFSH
Hide Arm/Group Description:
SJ-0021 (recombinant follitropin alfa) was administered subcutaneously (s.c.) at a starting dose of 75 International Unit (IU)/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
Urinary human follicle stimulating hormone (u-hFSH), a purified pituitary gonadotropin, was administered s.c. at a starting dose of 75 IU/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
Overall Number of Participants Analyzed 129 132
Measure Type: Number
Unit of Measure: percent biochemical pregnancy
17.8 15.2
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SJ-0021, u-hFSH
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.560
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
8.Secondary Outcome
Title Clinical Pregnancy Rate
Hide Description Clinical pregnancy was defined as existence of at least one ultrasonography confirmed gestational sac in the uterus, with or without heartbeat.
Time Frame Day 35-42 of post-treatment assessment period
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title SJ-0021 u-hFSH
Hide Arm/Group Description:
SJ-0021 (recombinant follitropin alfa) was administered subcutaneously (s.c.) at a starting dose of 75 International Unit (IU)/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
Urinary human follicle stimulating hormone (u-hFSH), a purified pituitary gonadotropin, was administered s.c. at a starting dose of 75 IU/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
Overall Number of Participants Analyzed 129 132
Measure Type: Number
Unit of Measure: percent clinical pregnancy
17.1 14.4
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SJ-0021, u-hFSH
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.555
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
9.Secondary Outcome
Title Ovulation Rate, Where Ovulation is Defined as a Serum P4 Level Greater Than or Equal to 10 ng/mL or Clinical Pregnancy
Hide Description 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.
Time Frame On Day 6±1 or 9±1 during post-treatment assessment period
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title SJ-0021 u-hFSH
Hide Arm/Group Description:
SJ-0021 (recombinant follitropin alfa) was administered subcutaneously (s.c.) at a starting dose of 75 International Unit (IU)/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
Urinary human follicle stimulating hormone (u-hFSH), a purified pituitary gonadotropin, was administered s.c. at a starting dose of 75 IU/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
Overall Number of Participants Analyzed 129 132
Measure Type: Number
Unit of Measure: percent ovulation
71.3 75.8
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SJ-0021, u-hFSH
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.416
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
10.Secondary Outcome
Title Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and AEs Leading to Study Drug Discontinuation
Hide Description 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.
Time Frame Pretrial observation period to post-treatment assessment period (Days 35-42)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least 1 dose of IMP. This was actually identical to the FAS population.
Arm/Group Title SJ-0021 u-hFSH
Hide Arm/Group Description:
SJ-0021 (recombinant follitropin alfa) was administered subcutaneously (s.c.) at a starting dose of 75 International Unit (IU)/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
Urinary human follicle stimulating hormone (u-hFSH), a purified pituitary gonadotropin, was administered s.c. at a starting dose of 75 IU/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
Overall Number of Participants Analyzed 129 132
Measure Type: Number
Unit of Measure: participants
TEAEs 69 66
SAEs 1 1
Discontinuation due to AEs 0 1
11.Secondary Outcome
Title Number of Participants With OHSS
Hide Description OHSS is a syndrome which can manifest with enlarged ovaries, advanced ascites with increased vascular permeability, pleural fluid accumulation, hemoconcentration, and increased blood clotting.
Time Frame Start of treatment period to post-treatment assessment period (Day 35-42)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least 1 dose of IMP. This was actually identical to the FAS population.
Arm/Group Title SJ-0021 u-hFSH
Hide Arm/Group Description:
SJ-0021 (recombinant follitropin alfa) was administered subcutaneously (s.c.) at a starting dose of 75 International Unit (IU)/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
Urinary human follicle stimulating hormone (u-hFSH), a purified pituitary gonadotropin, was administered s.c. at a starting dose of 75 IU/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
Overall Number of Participants Analyzed 129 132
Measure Type: Number
Unit of Measure: participants
10 5
Time Frame AEs were collected on an ongoing basis from day of written informed consent. All new AEs must be recorded until the final post-treatment examination, on Day 35-42 of the post-treatment assessment period.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title SJ-0021 u-hFSH
Hide Arm/Group Description SJ-0021 (recombinant follitropin alfa) was administered subcutaneously (s.c.) at a starting dose of 75 International Unit (IU)/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days. Urinary human follicle stimulating hormone (u-hFSH), a purified pituitary gonadotropin, was administered s.c. at a starting dose of 75 IU/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
All-Cause Mortality
SJ-0021 u-hFSH
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
SJ-0021 u-hFSH
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/129 (0.78%)      1/132 (0.76%)    
Reproductive system and breast disorders     
Ovarian hyperstimulation syndrome * 1  1/129 (0.78%)  1 1/132 (0.76%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (10.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
SJ-0021 u-hFSH
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   36/129 (27.91%)      40/132 (30.30%)    
Gastrointestinal disorders     
Abdominal pain lower * 1  6/129 (4.65%)  7 14/132 (10.61%)  17
Abdominal distension * 1  9/129 (6.98%)  10 7/132 (5.30%)  7
Ascites * 1  4/129 (3.10%)  4 7/132 (5.30%)  7
Infections and infestations     
Nasopharyngitis * 1  10/129 (7.75%)  10 11/132 (8.33%)  11
Nervous system disorders     
Headache * 1  6/129 (4.65%)  6 8/132 (6.06%)  9
Reproductive system and breast disorders     
Ovarian hyperstimulation syndrome * 1  9/129 (6.98%)  9 4/132 (3.03%)  4
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (10.0)
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
 
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Merck KGaA Communication Center
Organization: Merck Serono Co., Ltd., Japan, an affiliate of Merck KGaA, Darmstadt, Germany
Phone: +49-6151-72-5200
EMail: service@merckgroup.com
Publications of Results:
Taketani 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.
Layout table for additonal information
Responsible Party: Merck KGaA, Darmstadt, Germany
ClinicalTrials.gov Identifier: NCT01185782    
Obsolete Identifiers: NCT00467480
Other Study ID Numbers: IMP26648
First Submitted: August 11, 2010
First Posted: August 20, 2010
Results First Submitted: September 26, 2011
Results First Posted: February 24, 2012
Last Update Posted: December 27, 2013