Fertilization in Vitro Clinical Trial
Official title:
Post-Marketing Surveillance Orgalutran (Ganirelix)®
NCT number | NCT01304511 |
Other study ID # | P08198 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | February 2005 |
Est. completion date | December 2007 |
Verified date | April 2024 |
Source | Organon and Co |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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).
Status | Completed |
Enrollment | 711 |
Est. completion date | December 2007 |
Est. primary completion date | December 2007 |
Accepts healthy volunteers | |
Gender | Female |
Age group | N/A and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Organon and Co |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of retrieved oocytes by COH based on Per stage approach | Baseline to End of Study | ||
Primary | Number of Serious Adverse Events | Baseline to End of Study | ||
Primary | Number of Unlabeled (Unexpected) Adverse Drug Reactions | Baseline to End of Study | ||
Primary | Number of Labeled Adverse Drug Reactions | Baseline to End of Study | ||
Primary | Number of Non-serious Adverse Events | Baseline to End of Study | ||
Primary | Number of Adverse events by drug misuse/abuse or drug-drug interaction | Baseline to End of Study |
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