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

NCT ID: NCT00194649

Last Updated: 2008-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-06-30

Study Completion Date

2006-01-31

Brief Summary

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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

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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.

Conditions

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Contraception

Keywords

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Glycosphingolipids (GSL)

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

100 mg Miglustat BID (twice daily) for six weeks

Group Type EXPERIMENTAL

Miglustat (Zavesca)

Intervention Type DRUG

100 mg Miglustat BID (twice daily) for six weeks

Interventions

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Miglustat (Zavesca)

100 mg Miglustat BID (twice daily) for six weeks

Intervention Type DRUG

Other Intervention Names

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Zavseca

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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

NIH

Sponsor Role collaborator

University of Washington

OTHER

Sponsor Role lead

Responsible Party

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University of Washington

Principal Investigators

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John Amory

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

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University of Washington

Seattle, Washington, United States

Site Status

Countries

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United States

References

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Takamiya K, Yamamoto A, Furukawa K, Zhao J, Fukumoto S, Yamashiro S, Okada M, Haraguchi M, Shin M, Kishikawa M, Shiku H, Aizawa S, Furukawa K. Complex gangliosides are essential in spermatogenesis of mice: possible roles in the transport of testosterone. Proc Natl Acad Sci U S A. 1998 Oct 13;95(21):12147-52. doi: 10.1073/pnas.95.21.12147.

Reference Type BACKGROUND
PMID: 9770454 (View on PubMed)

Ritter G, Krause W, Geyer R, Stirm S, Wiegandt H. Glycosphingolipid composition of human semen. Arch Biochem Biophys. 1987 Sep;257(2):370-8. doi: 10.1016/0003-9861(87)90579-0.

Reference Type BACKGROUND
PMID: 3662530 (View on PubMed)

Fujimoto H, Tadano-Aritomi K, Tokumasu A, Ito K, Hikita T, Suzuki K, Ishizuka I. Requirement of seminolipid in spermatogenesis revealed by UDP-galactose: Ceramide galactosyltransferase-deficient mice. J Biol Chem. 2000 Jul 28;275(30):22623-6. doi: 10.1074/jbc.C000200200.

Reference Type BACKGROUND
PMID: 10801776 (View on PubMed)

Honke K, Hirahara Y, Dupree J, Suzuki K, Popko B, Fukushima K, Fukushima J, Nagasawa T, Yoshida N, Wada Y, Taniguchi N. Paranodal junction formation and spermatogenesis require sulfoglycolipids. Proc Natl Acad Sci U S A. 2002 Apr 2;99(7):4227-32. doi: 10.1073/pnas.032068299. Epub 2002 Mar 26.

Reference Type BACKGROUND
PMID: 11917099 (View on PubMed)

Platt FM, Neises GR, Karlsson GB, Dwek RA, Butters TD. N-butyldeoxygalactonojirimycin inhibits glycolipid biosynthesis but does not affect N-linked oligosaccharide processing. J Biol Chem. 1994 Oct 28;269(43):27108-14.

Reference Type BACKGROUND
PMID: 7929454 (View on PubMed)

van der Spoel AC, Jeyakumar M, Butters TD, Charlton HM, Moore HD, Dwek RA, Platt FM. Reversible infertility in male mice after oral administration of alkylated imino sugars: a nonhormonal approach to male contraception. Proc Natl Acad Sci U S A. 2002 Dec 24;99(26):17173-8. doi: 10.1073/pnas.262586099. Epub 2002 Dec 11.

Reference Type BACKGROUND
PMID: 12477936 (View on PubMed)

Beutler E. Gaucher disease. Curr Opin Hematol. 1997 Jan;4(1):19-23. doi: 10.1097/00062752-199704010-00004.

Reference Type BACKGROUND
PMID: 9050375 (View on PubMed)

Amory JK, Muller CH, Page ST, Leifke E, Pagel ER, Bhandari A, Subramanyam B, Bone W, Radlmaier A, Bremner WJ. Miglustat has no apparent effect on spermatogenesis in normal men. Hum Reprod. 2007 Mar;22(3):702-7. doi: 10.1093/humrep/del414. Epub 2006 Oct 25.

Reference Type RESULT
PMID: 17067996 (View on PubMed)

Other Identifiers

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U54HD042454

Identifier Type: NIH

Identifier Source: secondary_id

View Link

04-3806-D

Identifier Type: -

Identifier Source: org_study_id