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Completed

NCT Number: NCT00194649

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

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.

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Key information

Conditions

Contraception

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

University of Washington

Seattle, Washington, 98195, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Miglustat (Zavesca)

Drug

100 mg Miglustat BID (twice daily) for six weeks

Other names: Zavseca

Primary outcomes

  1. 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.

    Time frame: 3 months

Secondary outcomes

  1. Safety

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Official study title

Glycosphingolipid Inhibition and Spermatogenesis in Man: A Pilot Study

Acronym: MIG-2

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Sep 19, 2005
Registry last updated
Sep 19, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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