Journal of Andrology Testis Workshop 2009
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Published-Ahead-of-Print July 12, 2006, DOI:10.2164/jandrol.106.000281

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Pharmacokinetics of Testosterone Undecanoate Injected Alone or in Combination with Norethisterone Enanthate in Healthy Men

Ammar Qoubaitary , Cristina Meriggiola , Chiu Ming Ng , Leslie Lumbreras , Silvia Cerpolini , G. Pelusi , Peter D. Christensen , Laura Hull , Ronald S. Swerdloff , and Christina Wang *

* To whom correspondence should be addressed. E-mail: wang{at}labiomed.org.

Long acting injectable testosterone undecanoate (TU) is a promising androgen for male hormonal contraception. As a prerequisite for a planned multicenter male contraceptive efficacy study, we studied the pharmacokinetics of two doses of TU alone or in combination with Norethisterone enanthate (NET-E) in a prospective two center study, randomized for TU dose. 20 healthy male volunteers in each center were administered intramuscular injections of 750 or 1000 mg TU alone or in combination with 200 mg of NET-E IM every 8 weeks for three injections. There were no significant differences in maximum concentration and area under the curve (AUC) for serum total and free testosterone (T) between TU 750 and 1000 mg groups irrespective of whether TU was administered with 200 mg of NET-E. TU 1000 mg IM alone or with NET-E at 8 weekly intervals resulted in linear increases in average concentration and AUC of serum total and free T with each injection. Accumulation ratios of serum total and free T levels (calculated as 8 weeks post- to pre-injection levels) for each period showed significant increases in the TU+ NET-E groups. Serum gonadotropins levels and sperm concentration were more consistently suppressed in the TU 1000mg +NET-E group. We conclude that despite some accumulation of T, TU 1000 mg + NET-E 200 mg administered every 8 weeks may be preferable for the future contraceptive efficacy study because of more complete suppression of gonadotropins and spermatogenesis.


Key words: Androgen • Contraception • Spermatogenesis • azoospermia • norethisterone enanthate • oligozoospermia • testosterone




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