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

This study has been completed.
Sponsor:
Information provided by:
Schering-Plough
ClinicalTrials.gov Identifier:
NCT01304511
First received: February 24, 2011
Last updated: June 17, 2011
Last verified: June 2011
  Purpose

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).


Condition Intervention
Fertilization in Vitro
Drug: Orgalutran

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Post-Marketing Surveillance Orgalutran (Ganirelix)®

Resource links provided by NLM:


Further study details as provided by Schering-Plough:

Primary Outcome Measures:
  • Number of retrieved oocytes by COH based on Per stage approach [ Time Frame: Baseline to End of Study ] [ Designated as safety issue: No ]
  • Number of Serious Adverse Events [ Time Frame: Baseline to End of Study ] [ Designated as safety issue: Yes ]
  • Number of Unlabeled (Unexpected) Adverse Drug Reactions [ Time Frame: Baseline to End of Study ] [ Designated as safety issue: Yes ]
  • Number of Labeled Adverse Drug Reactions [ Time Frame: Baseline to End of Study ] [ Designated as safety issue: Yes ]
  • Number of Non-serious Adverse Events [ Time Frame: Baseline to End of Study ] [ Designated as safety issue: Yes ]
  • Number of Adverse events by drug misuse/abuse or drug-drug interaction [ Time Frame: Baseline to End of Study ] [ Designated as safety issue: Yes ]

Enrollment: 711
Study Start Date: February 2005
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Participants Treated
Women undergoing controlled ovarian COH for ART
Drug: Orgalutran
Other Name: Ganirelix®

  Eligibility

Genders Eligible for Study:   Female
Sampling Method:   Non-Probability Sample
Study Population

Women undergoing COH for ART

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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Vice President of Late Stage Development, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT01304511     History of Changes
Other Study ID Numbers: P08198
Study First Received: February 24, 2011
Last Updated: June 17, 2011
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Ganirelix
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014