Intramuscular injection of testosterone undecanoate for the treatment of male hypogonadism: phase I studies

in European Journal of Endocrinology
Authors:
HM BehreInstitute of Reproductive Medicine of the University, Domagkstrasse 11, D-48129 Munster, Germany.

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K AbshagenInstitute of Reproductive Medicine of the University, Domagkstrasse 11, D-48129 Munster, Germany.

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M OettelInstitute of Reproductive Medicine of the University, Domagkstrasse 11, D-48129 Munster, Germany.

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D HublerInstitute of Reproductive Medicine of the University, Domagkstrasse 11, D-48129 Munster, Germany.

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E NieschlagInstitute of Reproductive Medicine of the University, Domagkstrasse 11, D-48129 Munster, Germany.

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OBJECTIVE: In the search for long-acting testosterone preparations suited for substitution therapy of hypogonadal men, testosterone undecanoate (TU) dissolved in either tea seed oil or castor oil was investigated. DESIGN: In study I, 1000 mg TU in tea seed oil (125 mg/ml) were injected in equal parts into the gluteal muscles of seven hypogonadal men. In study II, 1000 mg TU in castor oil (250 mg/ml) were injected into one gluteal muscle of 14 patients. RESULTS: In comparison with published data on testosterone enanthate, most widely used for i.m. injections, the kinetic profiles of both TU preparations showed extended half-lives and serum levels not exceeding the upper limit of normal. The castor oil preparation had a longer half-life than TU in tea seed oil (33.9+/-4.9 vs 20.9+/-6.0 days (mean pm S.E.M.)). CONCLUSION: The longer half-life and the smaller injection volume make TU in castor oil a strong candidate for further applications in substitution therapy and in trials for male contraception.

 

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