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

April 1, 2024 updated by: Organon and Co

Post-Marketing Surveillance Orgalutran (Ganirelix)®

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

711

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Women undergoing COH for ART

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Participants Treated
Women undergoing controlled ovarian COH for ART
Drug: Orgalutran
Other Names:
  • Ganirelix®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of retrieved oocytes by COH based on Per stage approach
Time Frame: Baseline to End of Study
Baseline to End of Study
Number of Serious Adverse Events
Time Frame: Baseline to End of Study
Baseline to End of Study
Number of Unlabeled (Unexpected) Adverse Drug Reactions
Time Frame: Baseline to End of Study
Baseline to End of Study
Number of Labeled Adverse Drug Reactions
Time Frame: Baseline to End of Study
Baseline to End of Study
Number of Non-serious Adverse Events
Time Frame: Baseline to End of Study
Baseline to End of Study
Number of Adverse events by drug misuse/abuse or drug-drug interaction
Time Frame: Baseline to End of Study
Baseline to End of Study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Organon and Co

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2005

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

February 24, 2011

First Submitted That Met QC Criteria

February 24, 2011

First Posted (Estimated)

February 25, 2011

Study Record Updates

Last Update Posted (Actual)

April 3, 2024

Last Update Submitted That Met QC Criteria

April 1, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P08198

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Fertilization in Vitro

Clinical Trials on Orgalutran

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Burundi

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe