A Korean Post-Marketing Surveillance Study On Pergoveris® (Follitropin Alfa + Lutropin Alfa)
|ClinicalTrials.gov Identifier: NCT01416987|
Recruitment Status : Completed
First Posted : August 15, 2011
Last Update Posted : May 23, 2018
This prospective study will collect safety information from more than 600 patients treated with Pergoveris®.
During the Post-Marketing Surveillance (PMS) period, data about the patient´s background, patient'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) will be collected for study purposes.
The post marketing surveillance is based on all cases treated with Pergoveris®.
|Condition or disease|
|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|
- Frequency and severity of all adverse events regardless of the causal relationship to Pergoveris® [ Time Frame: 30 month ]
- Clinical pregnancy [ Time Frame: 30 month ]
- Percentage of patients with more than one follicle greater than 17mm on day of human chorionic gonadotrophin (HCG) administration [ Time Frame: 30 month ]
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.|