Post-Marketing Surveillance of the Safety and Efficacy of Orgalutran (Ganirelix)®

Post-Marketing Surveillance Orgalutran (Ganirelix)®

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01304511

Enrollment

711

Registered

2011-02-25

Start date

2005-02-28

Completion date

2007-12-31

Last updated

2024-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fertilization in Vitro

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).

Interventions

DRUGOrgalutran

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

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

Design outcomes

Primary

Measure	Time frame
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026