CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 8 enrolled
Drug / intervention
Miglustat (Zavesca)drug
Likely dose
Miglustat (Zavesca) 100 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00194649
NCT00194649Phase 4Completed
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Glycosphingolipid Inhibition and Spermatogenesis in Man: A Pilot Study

University of Washington·interventional·Posted Sep 19, 2005·Updated Sep 19, 2008

In Brief

A Phase 4 clinical trial evaluating Miglustat (Zavesca) for Contraception. Completed, enrolled 8 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsContraception
CountriesUnited States
CollaboratorsEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Timeline

Phase 4CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 19, 2005
Enrollment StartJun 1, 2005
Primary CompletionJan 1, 2006
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 20.8 years ago

Interventions

Miglustat (Zavesca)drug

100 mg Miglustat BID (twice daily) for six weeks