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

NCT ID: NCT01304511

Last Updated: 2024-04-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

711 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-02-28

Study Completion Date

2007-12-31

Brief Summary

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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).

Detailed Description

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Conditions

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Fertilization in Vitro

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Participants Treated

Women undergoing controlled ovarian COH for ART

Orgalutran

Intervention Type DRUG

Interventions

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Orgalutran

Intervention Type DRUG

Other Intervention Names

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Ganirelix®

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Organon and Co

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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P08198

Identifier Type: -

Identifier Source: org_study_id

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