Glycosphingolipid Inhibition and Spermatogenesis in Man: A Pilot Study (MIG 2)

Phase 4

Completed

• Conditions: Contraception
• Interventions: Drug: Miglustat (Zavesca)

• Registration Number: NCT00194649
• Lead Sponsor: University of Washington

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.

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 Timeline

• Study Start: 2005-06
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-19
• Primary Completion: 2006-01
• Study Completion: 2006-01
• Status Verified: 2008-09
• Last Update Submitted: 2008-09-18
• Last Update Posted: 2008-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 8

Inclusion Criteria

• Healthy male, normal lab test

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Exclusion Criteria

• Abnormal lab test, history or evidence of significant chronic or acute medical illness, previous or current ethanol or anabolic steroid abuse.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Miglustat (Zavesca)	100 mg Miglustat BID (twice daily) for six weeks

Primary Outcome Measures

Name	Time	Method
The impact of GSL inhibition on human spermatogenesis, if impairment is seen with Miglustat administration, larger contraceptive efficacy studies of Miglustat or other inhibitors of GSL's will be performed.	3 months

Secondary Outcome Measures

Name	Time	Method
Safety	3 months

Trial Locations

Locations (1)

University of Washington; 🇺🇸 Seattle, Washington, United States