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Clinical trial

Post-Marketing Surveillance Orgalutran (Ganirelix)®

ID
Name
P08198
Description
The purpose of this post-marketing surveillance is to identify problems and questions regarding the safety and efficacy of Orgalutran (Ganirelix)® when used for the prevention of premature luteinizing hormone (LH) surges in women undergoing controlled ovarian hyperstimulation (COH) for assisted reproduction techniques (ART).
Trial arms
Trial start
2005-02-01
Estimated PCD
2007-12-01
Trial end
2007-12-01
Status
Completed
Treatment
Orgalutran
Arms:
Participants Treated
Other names:
Ganirelix®
Size
711
Primary endpoint
Number of retrieved oocytes by COH based on Per stage approach
Baseline to End of Study
Number of Serious Adverse Events
Baseline to End of Study
Number of Unlabeled (Unexpected) Adverse Drug Reactions
Baseline to End of Study
Number of Labeled Adverse Drug Reactions
Baseline to End of Study
Number of Non-serious Adverse Events
Baseline to End of Study
Number of Adverse events by drug misuse/abuse or drug-drug interaction
Baseline to End of Study
Eligibility criteria
Inclusion Criteria: * Must be undergoing COH for ART Exclusion Criteria: * Hypersensitivity to the active substance or to any of the excipients * Hypersensitivity to gonadotropin-releasing hormone (GnRH) or any other GnRH analogue * Moderate or severe impairment of renal or hepatic function * Pregnancy or lactation
Protocol
{'studyType': 'OBSERVATIONAL', 'designInfo': {'observationalModel': 'CASE_ONLY', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 711, 'type': 'ACTUAL'}}
Updated at
2024-04-03

1 organization

1 product

1 indication

Organization
Organon and Co
Product
Orgalutran
Indication
In Vitro Fertilization