Viewing Study NCT01417195


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Study NCT ID: NCT01417195
Status: COMPLETED
Last Update Posted: 2014-05-16
First Post: 2011-07-28
Is NOT Gene Therapy: True
Has Adverse Events: True

Brief Title: Menopur Mixed Protocol
Sponsor: Ferring Pharmaceuticals
Organization:

Study Overview

Official Title: A Multicenter, Randomized, Open-label, Parallel-group Study Comparing the Combination of MenopurĀ® and BravelleĀ® With MenopurĀ® Alone in Subjects Undergoing Assisted Reproductive Technology (ART)
Status: COMPLETED
Status Verified Date: 2014-05
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: COMBINE
Brief Summary: The objective of this study was to compare the fertilization rate between the combination of Menopur and Bravelle mixed in the same syringe and Menopur alone, both administered subcutaneously (SC), in subjects undergoing Assisted Reproductive Technology (ART). Additionally the study assessed subjects' ability to mix and store the combination of Menopur and Bravelle and to assess safety of the Menopur and Bravelle combination.
Detailed Description: None

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: