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

Fertilization in Vitro Clinical Trial

Official title:

Post-Marketing Surveillance Orgalutran (Ganirelix)®

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01304511
• Other study ID #: P08198
• Status: Completed
• Start date: February 2005
• Est. completion date: December 2007

Study information

• Verified date: April 2024
• Source: Organon and Co
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 711
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Fertilization in Vitro

Intervention

Drug:
• Orgalutran

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organon and Co

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of retrieved oocytes by COH based on Per stage approach		Baseline to End of Study
Primary	Number of Serious Adverse Events		Baseline to End of Study
Primary	Number of Unlabeled (Unexpected) Adverse Drug Reactions		Baseline to End of Study
Primary	Number of Labeled Adverse Drug Reactions		Baseline to End of Study
Primary	Number of Non-serious Adverse Events		Baseline to End of Study
Primary	Number of Adverse events by drug misuse/abuse or drug-drug interaction		Baseline to End of Study