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A Korean Post-Marketing Surveillance Study On Pergoveris® (Follitropin Alfa + Lutropin Alfa)

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ClinicalTrials.gov Identifier: NCT01416987
Recruitment Status : Completed
First Posted : August 15, 2011
Results First Posted : July 19, 2019
Last Update Posted : July 19, 2019
Sponsor:
Collaborator:
Merck Ltd.
Information provided by (Responsible Party):
Merck KGaA, Darmstadt, Germany

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Infertility
Intervention Drug: Pergoveris®
Enrollment 600
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Pergoveris®
Hide Arm/Group Description Participants received once daily injection of a single vial of Pergoveris® which contained 150 International Units (IU) of follitropin alfa (r-hFSH) and 75 IU of lutropin alfa (r-hLH), for approximately 8 days.
Period Title: Overall Study
Started 600
Completed 600
Not Completed 0
Arm/Group Title Pergoveris®
Hide Arm/Group Description Participants received once daily injection of a single vial of Pergoveris® which contained 150 International Units (IU) of follitropin alfa (r-hFSH) and 75 IU of lutropin alfa (r-hLH), for approximately 8 days.
Overall Number of Baseline Participants 600
Hide Baseline Analysis Population Description
Safety analysis set included all participants who received at least one dose of Pergoveris®.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 600 participants
34.58  (3.83)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 600 participants
Female
600
 100.0%
Male
0
   0.0%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
1.Primary Outcome
Title Number of Participants With Adverse Event (AE) and Adverse Drug Reaction (ADR)
Hide Description Adverse Event (AE) was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Adverse events included both Serious AEs and non-serious AEs. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Adverse Drug Reactions (ADR) was defined as an adverse event for which a causal relationship between the product and the occurrence was suspected, that was judged possible or probable by the reporting physician.
Time Frame 2463 days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least one dose of Pergoveris®.
Arm/Group Title Pergoveris®
Hide Arm/Group Description:
Participants received once daily injection of a single vial of Pergoveris® which contained 150 International Units (IU) of follitropin alfa (r-hFSH) and 75 IU of lutropin alfa (r-hLH), for approximately 8 days.
Overall Number of Participants Analyzed 600
Measure Type: Count of Participants
Unit of Measure: Participants
Adverse event (AE)
16
   2.7%
Adverse drug reaction (ADR)
13
   2.2%
2.Secondary Outcome
Title Number of Participants With at Least One Follicle of More Than 17 Millimeter (mm) of Mean Diameter on Ultrasonography
Hide Description Number of participants with one follicle of more than 17mm of mean diameter on ultrasonography were reported.
Time Frame 2463 days
Hide Outcome Measure Data
Hide Analysis Population Description
Effectiveness analysis set included participants who were evaluated for follicular growth (FG) after treatment with Pergoveris®, except those; who were not assessed for FG; whose assessments of FG were considered 'undecidable' based on Human Chorionic Gonadotropin (HCG) not administered, ultrasonography not done on the day of HCG administration.
Arm/Group Title Pergoveris®
Hide Arm/Group Description:
Participants received once daily injection of a single vial of Pergoveris® which contained 150 International Units (IU) of follitropin alfa (r-hFSH) and 75 IU of lutropin alfa (r-hLH), for approximately 8 days.
Overall Number of Participants Analyzed 532
Measure Type: Count of Participants
Unit of Measure: Participants
528
  99.2%
3.Secondary Outcome
Title Number of Participants With Clinical Pregnancy as Per Safety Analysis Set
Hide Description The clinical pregnancy was defined as a positive serum in urine HCG test or as the presence of gestational sac or yolk sac by an ultrasonography confirmation.
Time Frame 2463 days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least one dose of Pergoveris®.
Arm/Group Title Pergoveris®
Hide Arm/Group Description:
Participants received once daily injection of a single vial of Pergoveris® which contained 150 International Units (IU) of follitropin alfa (r-hFSH) and 75 IU of lutropin alfa (r-hLH), for approximately 8 days.
Overall Number of Participants Analyzed 600
Measure Type: Count of Participants
Unit of Measure: Participants
246
  41.0%
4.Secondary Outcome
Title Number of Participants With Clinical Pregnancy as Per Effectiveness Analysis Set
Hide Description The clinical pregnancy was defined as a positive serum in urine HCG test or as the presence of gestational sac or yolk sac by an ultrasonography confirmation.
Time Frame 2463 days
Hide Outcome Measure Data
Hide Analysis Population Description
Effectiveness analysis set included participants who were evaluated for follicular growth (FG) after treatment with Pergoveris ®, except those; who were not assessed for FG; whose assessments of FG were considered 'undecidable' based on Human Chorionic Gonadotropin (HCG) not administered, ultrasonography not done on the day of HCG administration.
Arm/Group Title Pergoveris®
Hide Arm/Group Description:
Participants received once daily injection of a single vial of Pergoveris® which contained 150 International Units (IU) of follitropin alfa (r-hFSH) and 75 IU of lutropin alfa (r-hLH), for approximately 8 days.
Overall Number of Participants Analyzed 532
Measure Type: Count of Participants
Unit of Measure: Participants
227
  42.7%
Time Frame 2463 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Pergoveris®
Hide Arm/Group Description Participants received once daily injection of a single vial of Pergoveris® which contained 150 International Units (IU) of follitropin alfa (r-hFSH) and 75 IU of lutropin alfa (r-hLH), for approximately 8 days.
All-Cause Mortality
Pergoveris®
Affected / at Risk (%)
Total   0/600 (0.00%) 
Hide Serious Adverse Events
Pergoveris®
Affected / at Risk (%)
Total   2/600 (0.33%) 
Pregnancy, puerperium and perinatal conditions   
Ectopic pregnancy * 1  1/600 (0.17%) 
Reproductive system and breast disorders   
Ovarian hyperstimulation syndrome * 1  1/600 (0.17%) 
1
Term from vocabulary, MedDRA, Version 21.0
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Pergoveris®
Affected / at Risk (%)
Total   14/600 (2.33%) 
Gastrointestinal disorders   
Abdominal distension * 1  1/600 (0.17%) 
Abdominal pain lower * 1  1/600 (0.17%) 
Nausea * 1  1/600 (0.17%) 
General disorders   
Injection site erythema * 1  1/600 (0.17%) 
Injection site pain * 1  1/600 (0.17%) 
Injection site pruritus * 1  1/600 (0.17%) 
Infections and infestations   
Nasopharyngitis * 1  1/600 (0.17%) 
Reproductive system and breast disorders   
Ovarian hyperstimulation syndrome * 1  7/600 (1.17%) 
Respiratory, thoracic and mediastinal disorders   
Nasal obstruction * 1  1/600 (0.17%) 
1
Term from vocabulary, MedDRA, Version 21.0
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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: Communication Center
Organization: Merck KGaA, Darmstadt, Germany
Phone: +49-6151-72-5200
EMail: service@emdgroup.com
Layout table for additonal information
Responsible Party: Merck KGaA, Darmstadt, Germany
ClinicalTrials.gov Identifier: NCT01416987    
Other Study ID Numbers: EMR200061-507
First Submitted: August 12, 2011
First Posted: August 15, 2011
Results First Submitted: May 9, 2019
Results First Posted: July 19, 2019
Last Update Posted: July 19, 2019