Ignite Creation Date:
2024-05-05 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00194649
Status:
COMPLETED
Last Update Posted:
2008-09-19
First Post:
2005-09-13
Brief Title:
Glycosphingolipid Inhibition and Spermatogenesis in Man A Pilot Study MIG 2
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
Glycosphingolipid Inhibition and Spermatogenesis in Man A Pilot Study
Status:
COMPLETED
Status Verified Date:
2008-09
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:
MIG-2
Brief Summary:
The purpose of this research study is to help in the development of safe effective and reversible male contraception We are examining the impact of the drug Miglustat on sperm production in normal men
We want to see if Miglustat will inhibit sperm production in men and act as a reversible male contraceptive as a study in mice administered Miglustat showed a reversible inhibition of sperm production We believe Miglustat may have some potential as a safe reversible male contraceptive
We want to see if Miglustat will inhibit sperm production in men and act as a reversible male contraceptive as a study in mice administered Miglustat showed a reversible inhibition of sperm production We believe Miglustat may have some potential as a safe reversible male contraceptive
Detailed Description:
Glycosphingolipids GSL are a main constituent of the sperm cell membrane in mammals Male mice deficient in enzymes involved in GSL synthesis have severely impaired fertility and knockout mice are infertile Recently it was demonstrated that administration to mice of an inhibitor of ceramide-specific glycosyltransferase the first step in the biosynthetic pathway of GSL formation resulted in reversible infertility without discernable adverse side effects This inhibitor was Miglustat which is an alkylated imino sugar The impact of Miglustat therapy on human spermatogenesis is unknown If the effects on sperm morphology and motility are similar to those observed in mice Miglustat or other GSL inhibitors might have potential utility as non-hormonal male contraceptives
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U54HD042454 | NIH | None | httpsreporternihgovquickSearchU54HD042454 |