Testosterone undecanoate is a long-acting man-made version of testosterone, the natural male sexual hormone. Testosterone is responsible for the normal growth and development of male sex organs and characteristics. It includes growth and development of male organs of penis, testicles, prostate, body hair, vocal cord thickening, and muscle and fat distribution. The FDA approved testosterone undecanoate in March 2014.
Testosterone undecandoate might be prescribed for the treatment of hypogonadism in men, but more recently, the androgen has been used as a male contraceptive. Since the 1980s, researchers have been testing testosterone variations in an attempt to develop one. While this testosterone ester produces effective results in Asian men, the hormone requires the addition of other hormones to produce equally successful outcomes for men in other countries.
This ester of testosterone suppresses follicle stimulating hormone (FSH) and luteinizing hormone (LH), interfering with the signals required by the testes to produce sperm and resulting in lowered sperm counts. Men usually do not experience the full effects of treatment, however, until after the first two or three months of receiving the drug. Sperm counts then remain low for the duration of treatment. Counts generally return to normal anywhere from two to six months after cessation of treatment.
Chinese researchers first combined 200 milligrams (mg) of testosterone undecandoate with tea tree oil and administered the formula by intramuscular injection. Men received periodic injections over the course of 30 months. During the first trials, 80% to 90% of the men involved in the study developed sperm counts of less than one million sperm per milliliter (ml) of ejaculate. Normal sperm counts average around 20 million sperm per ml. After three months of treatment, the male contraceptive was 90% to 100% effective.
Testosterone undecanoate has a very long elimination half-life and mean residence time when given as a depot intramuscular injection.The elimination half-life and mean residence time of testosterone undecanoate are 2.5-fold and 4-fold longer than those of testosterone enanthate (the values for testosterone enanthate being 4.5 days and 8.5 days,respectively).
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