A Korean Post-Marketing Surveillance Study On Pergoveris® (Follitropin Alfa + Lutropin Alfa)
|ClinicalTrials.gov Identifier: NCT01416987|
Recruitment Status : Completed
First Posted : August 15, 2011
Results First Posted : July 19, 2019
Last Update Posted : July 19, 2019
This prospective study collected safety information from more than 600 participants treated with Pergoveris®.
During the Post-Marketing Surveillance (PMS) period, data about the participant's background, participant's medical history, Pergoveris® indication, prior infertility medication, Pergoveris® treatment status, concomitant drugs, all adverse events (regardless of the causal relationship to Pergoveris®) and efficacy (follicular growth and clinical pregnancy) were collected for study purposes.The post marketing surveillance was based on all cases treated with Pergoveris®.
|Condition or disease||Intervention/treatment|
|Study Type :||Observational|
|Actual Enrollment :||600 participants|
|Official Title:||A Korean Post-Marketing Surveillance Study On Pergoveris® (Follitropin Alfa + Lutropin Alfa)|
|Actual Study Start Date :||August 14, 2011|
|Actual Primary Completion Date :||May 10, 2018|
|Actual Study Completion Date :||May 10, 2018|
- Drug: Pergoveris®
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.
- Number of Participants With Adverse Event (AE) and Adverse Drug Reaction (ADR) [ Time Frame: 2463 days ]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.
- Number of Participants With at Least One Follicle of More Than 17 Millimeter (mm) of Mean Diameter on Ultrasonography [ Time Frame: 2463 days ]Number of participants with one follicle of more than 17mm of mean diameter on ultrasonography were reported.
- Number of Participants With Clinical Pregnancy as Per Safety Analysis Set [ Time Frame: 2463 days ]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.
- Number of Participants With Clinical Pregnancy as Per Effectiveness Analysis Set [ Time Frame: 2463 days ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01416987
|Korea, Republic of|
|Seoul, Korea, Republic of, 04619|
|Seoul, Korea, Republic of, 05505|
|Study Director:||Medical Responsible||Merck Ltd.|