Ignite Creation Date:
2024-05-05 @ 4:51 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00328926
Status:
TERMINATED
Last Update Posted:
2013-08-07
First Post:
2006-05-20
Brief Title:
Luveris Lutropin Alfa for Injection in Women With Hypogonadotropic Hypogonadism Luteinizing Hormone LH Less Than 12 International Unit Per Liter IUL
Sponsor:
EMD Serono
Organization:
EMD Serono
Study Overview
Official Title:
A Phase IV Multicenter Randomized Double-blinded Clinical Trial to Confirm the Efficacy of the 75 IU Dose of Luveris vs Placebo When Administered With Follitropin Alfa for Induction of Follicular Development and Pregnancy in Hypogonadotropic Hypogonadal Women With Profound LH Deficiency as Defined by a Baseline LH Level 12 IUL
Status:
TERMINATED
Status Verified Date:
2013-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Please see Purpose statement
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Sponsor has decided to discontinue Luveris in the United States US due to level of customer demand for this product and not due to any efficacy or safety concerns
Detailed Description:
To confirm the efficacy of the 75 IU dose of Luveris compared to placebo when administered concomitantly with follitropin alfa for induction of clinical pregnancy in women with hypogonadotropic hypogonadism and profound LH deficiency LH 12 IUL and to study the efficacy of a lower dose 25 IU of Luveris compared to placebo when administered concomitantly with follitropin alfa for induction of follicular development in women with hypogonadotropic hypogonadism and profound LH deficiency LH 12 IUL
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