Post-Marketing Surveillance of the Safety and Efficacy of Orgalutran (Ganirelix)®
Post-Marketing Surveillance Orgalutran (Ganirelix)®
1 other identifier
observational
711
0 countries
N/A
Brief Summary
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2005
Typical duration for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2007
CompletedFirst Submitted
Initial submission to the registry
February 24, 2011
CompletedFirst Posted
Study publicly available on registry
February 25, 2011
CompletedApril 3, 2024
April 1, 2024
2.8 years
February 24, 2011
April 1, 2024
Conditions
Outcome Measures
Primary Outcomes (6)
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
Study Arms (1)
Participants Treated
Women undergoing controlled ovarian COH for ART
Interventions
Eligibility Criteria
Women undergoing COH for ART
You may qualify if:
- Must be undergoing COH for ART
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Organon and Colead
MeSH Terms
Interventions
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 24, 2011
First Posted
February 25, 2011
Study Start
February 1, 2005
Primary Completion
December 1, 2007
Study Completion
December 1, 2007
Last Updated
April 3, 2024
Record last verified: 2024-04