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.
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.
Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
University of Washington
University of Washington
Results (where available)
- Source: http://clinicaltrials.gov/show/NCT00194649
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Methods of contraception in which physical, chemical, or biological means are used to prevent the SPERM from reaching the fertilizable OVUM.
Behavior patterns of those practicing CONTRACEPTION.
Prevention of CONCEPTION by blocking fertility temporarily, or permanently (STERILIZATION, REPRODUCTIVE). Common means of reversible contraception include NATURAL FAMILY PLANNING METHODS; CONTRACEPTIVE AGENTS; or CONTRACEPTIVE DEVICES.
Contraceptive methods based on immunological processes and techniques, such as the use of CONTRACEPTIVE VACCINES.
A synthetic progestational hormone with actions similar to those of PROGESTERONE and about twice as potent as its racemic or (+-)-isomer (NORGESTREL). It is used for contraception, control of menstrual disorders, and treatment of endometriosis.
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