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

This study has been completed.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp. Identifier:
First received: February 24, 2011
Last updated: April 28, 2015
Last verified: April 2015
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 ]
  • Number of Serious Adverse Events [ Time Frame: Baseline to End of Study ]
  • Number of Unlabeled (Unexpected) Adverse Drug Reactions [ Time Frame: Baseline to End of Study ]
  • Number of Labeled Adverse Drug Reactions [ Time Frame: Baseline to End of Study ]
  • Number of Non-serious Adverse Events [ Time Frame: Baseline to End of Study ]
  • Number of Adverse events by drug misuse/abuse or drug-drug interaction [ Time Frame: Baseline to End of Study ]

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®


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Sampling Method:   Non-Probability Sample
Study Population
Women undergoing COH for ART

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

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT01304511     History of Changes
Other Study ID Numbers: P08198
Study First Received: February 24, 2011
Last Updated: April 28, 2015

Additional relevant MeSH terms:
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs processed this record on April 26, 2017