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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01304511
First Posted: February 25, 2011
Last Update Posted: April 29, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  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 ]
  • 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®

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes 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

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01304511     History of Changes
Other Study ID Numbers: P08198
First Submitted: February 24, 2011
First Posted: February 25, 2011
Last Update Posted: April 29, 2015
Last Verified: April 2015

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