Status:
COMPLETED
A Korean Post-Marketing Surveillance Study On Pergoveris® (Follitropin Alfa + Lutropin Alfa)
Lead Sponsor:
Merck KGaA, Darmstadt, Germany
Collaborating Sponsors:
Merck Ltd.
Conditions:
Infertility
Eligibility:
FEMALE
Brief Summary
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 backgro...
Eligibility Criteria
Inclusion
- Participants, who were eligible for Pergoveris® treatment according to the indication in the national label of Pergoveris®. The national label approved by Korea Food \& Drug Administration is "Pergoveris® in association with a follicle stimulating hormone(FSH) preparation was recommended for the stimulation of follicular development in women with severe Luteinizing Hormone (LH) and FSH deficiency. In clinical trials these participants were defined by an endogenous serum LH level less than (\<)1.2 International units per liter IU/L"
Exclusion
- According to national label
Key Trial Info
Start Date :
August 14 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 10 2018
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT01416987
Start Date
August 14 2011
End Date
May 10 2018
Last Update
July 19 2019
Active Locations (2)
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1
Research site
Seoul, South Korea, 04619
2
Research site
Seoul, South Korea, 05505