Glycosphingolipid Inhibition and Spermatogenesis in Man: A Pilot Study (MIG 2) (MIG-2)
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About
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.
Full 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.
Enrollment
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Inclusion criteria
- Healthy male, normal lab test
Exclusion criteria
- Abnormal lab test, history or evidence of significant chronic or acute medical illness, previous or current ethanol or anabolic steroid abuse.
Trial design
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Interventional model
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8 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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