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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00194649
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : September 19, 2008
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by:
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.


Condition or disease Intervention/treatment Phase
Contraception Drug: Miglustat (Zavesca) Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Glycosphingolipid Inhibition and Spermatogenesis in Man: A Pilot Study
Study Start Date : June 2005
Actual Primary Completion Date : January 2006
Actual Study Completion Date : January 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Control
Drug Information available for: Miglustat

Arm Intervention/treatment
Experimental: 1
100 mg Miglustat BID (twice daily) for six weeks
Drug: Miglustat (Zavesca)
100 mg Miglustat BID (twice daily) for six weeks
Other Name: Zavseca




Primary Outcome Measures :
  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 Outcome Measures :
  1. Safety [ Time Frame: 3 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00194649


Locations
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United States, Washington
University of Washington
Seattle, Washington, United States, 98195
Sponsors and Collaborators
University of Washington
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
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Principal Investigator: John Amory University of Washington
Additional Information:
Publications of Results:
Other Publications:

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Responsible Party: John K Amory, MD, MPH, University of Washington
ClinicalTrials.gov Identifier: NCT00194649    
Other Study ID Numbers: 04-3806-D
U54HD042454 ( U.S. NIH Grant/Contract )
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: September 19, 2008
Last Verified: September 2008
Keywords provided by University of Washington:
Glycosphingolipids (GSL)
Additional relevant MeSH terms:
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Miglustat
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Glycoside Hydrolase Inhibitors
Hypoglycemic Agents
Physiological Effects of Drugs