Ignite Creation Date:
2024-05-05 @ 5:03 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00378001
Status:
COMPLETED
Last Update Posted:
2015-02-16
First Post:
2006-09-15
Brief Title:
Clinical Efficacy and Tolerability of Two FSH Preparations Human FSH Versus rFSH - Follitropin Alpha in Women Undergoing IVF
Sponsor:
IBSA Institut Biochimique SA
Organization:
IBSA Institut Biochimique SA
Study Overview
Official Title:
A Prospective Multicenter Investigator Blinded Randomized Concurrent Control Study of Efficacy and Tolerability of Two FSH Preparations Fostimon Versus Gonal-F in Women Undergoing IVF
Status:
COMPLETED
Status Verified Date:
2015-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the study is to evaluate the clinical efficacy and general tolerability of two different subcutaneous FSH preparations Fostimon IBSA vs Gonal-F Serono Inc when administered to patients undergoing controlled ovarian stimulation for IVF
Detailed Description:
This is a prospective multicenter investigator blinded randomized concurrent control phase III clinical trial Patients meeting the eligibility requirements of the study will be randomly assigned to receive either the test drug Fostimon IBSA or the reference drug Gonal-F Serono Inc Investigators will be blinded by not allowing them to have any contact with the study medications supplied in boxes labeled in a manner that does not reveal the content of the boxes and requesting that patients do not make any statements to the investigator that might indicate the treatment to which they were assigned Equivalence testing with regard to the primary outcome variable will establish whether the two treatments are indeed similarly effective
Study Oversight
Has Oversight DMC:
None
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?:
None