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

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ClinicalTrials.gov Identifier: NCT01304511
Recruitment Status : Completed
First Posted : February 25, 2011
Last Update Posted : April 29, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief 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).

Condition or disease Intervention/treatment
Fertilization in Vitro Drug: Orgalutran

Study Type : Observational
Actual Enrollment : 711 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Post-Marketing Surveillance Orgalutran (Ganirelix)®
Study Start Date : February 2005
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Participants Treated
Women undergoing controlled ovarian COH for ART
Drug: Orgalutran
Other Name: Ganirelix®




Primary Outcome Measures :
  1. Number of retrieved oocytes by COH based on Per stage approach [ Time Frame: Baseline to End of Study ]
  2. Number of Serious Adverse Events [ Time Frame: Baseline to End of Study ]
  3. Number of Unlabeled (Unexpected) Adverse Drug Reactions [ Time Frame: Baseline to End of Study ]
  4. Number of Labeled Adverse Drug Reactions [ Time Frame: Baseline to End of Study ]
  5. Number of Non-serious Adverse Events [ Time Frame: Baseline to End of Study ]
  6. Number of Adverse events by drug misuse/abuse or drug-drug interaction [ Time Frame: Baseline to End of Study ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
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

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01304511     History of Changes
Other Study ID Numbers: P08198
First Posted: February 25, 2011    Key Record Dates
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