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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01304511
First received: February 24, 2011
Last updated: May 21, 2014
Last verified: May 2014
  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 Merck Sharp & Dohme Corp.:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01304511     History of Changes
Other Study ID Numbers: P08198
Study First Received: February 24, 2011
Last Updated: May 21, 2014
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 September 18, 2014