Clinical trial with testosterone undecanoate for male fertility control

Nieschlag, Eberhard; Hoogen, H.; Bölk, M.; Schuster, Herbert; Wickings, E. Jean

doi:10.1016/0010-7824(78)90045-8

Cited by 70 publications

(27 citation statements)

References 8 publications

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“…It is most likely that the difference in sperm suppression between this and our previous study is attributable to the more limited ability of T undecanoate to suppress gonadotropin secretion when compared with T enanthate (17,18). Similarly the administration of T undecanoate, alone or in combination with GnRH agonists, to normal men for male contraception, induced only a poor suppression of gonadotropins (17,18).…”

contrasting

confidence: 64%

An oral regimen of cyproterone acetate and testosterone undecanoate for spermatogenic suppression in men

Meriggiola¹,

Bremner²,

Costantino³

et al. 1997

Fertility and Sterility

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Objective: To test the effectiveness, safety, and reversibility of the combined administration of cyproterone acetate and T undecanoate.Design: Open clinical trial. Setting: Healthy volunteers in an academic research environment. Patient(s):Eight healthy men, aged 25-42 years were selected. Intervention(s): Cyproterone acetate, 12.5 mg, and T undecanoate, 80 mg, were administered orally twice daily for 16 weeks.Main Outcome Measure(s): Semen analyses every 2 weeks; physical examination, chemistries, hematology, prostatic-specific antigen, gonadotropins and T levels, and a questionnaire on sexual and behavioral function every 4 weeks. Result(s):In all subjects a profound suppression of spermatogenesis occurred; one subject became azoospermic, five subjects had sperm counts of 53 x lO?mL, and in two subjects sperm counts were 4 and 6 x lO?mL in week 16. Sperm counts returned to baseline in all men afier hormone administration was discontinued. No changes in metabolic parameters and total prostatic-specific antigen were detected. Hemoglobin and hematocrit decreased statistically significantly at week 16 of treatment and returned to baseline by week 12 of recovery. There was no change in sexual function or behavior. Conclusion(s):The oral administration of T undecanoate plus cyproterone acetate induces a profound suppression of spermatogenesis with no major adverse effects. These data suggest the feasibility of oral contraception in men.( the physiological range (1). These T formulations are not acceptable for long-term contraception by the population at large. Oral preparations or long-acting (3-4 months) injections would be much more acceptable techniques (2, 3). Oral regimens are preferred over long-acting formulations by some men because they provide more personal control, allowing users to stop when they want to and do not require any kind of painful procedure sometimes

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contrasting

confidence: 64%

An oral regimen of cyproterone acetate and testosterone undecanoate for spermatogenic suppression in men

Meriggiola¹,

Bremner²,

Costantino³

et al. 1997

Fertility and Sterility

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“…The application of androgens for male contraception was initially evaluated in the 1970's (65,66). Male hormonal contraception requires the delivery of either exogenous testosterone alone or in combination with a progestogen in order to suppress LH and FSH secretion from the pituitary.…”

Section: Alternative Uses Of Transdermal Testosteronementioning

confidence: 99%

Transdermal delivery of testosterone

Hadgraft

Lane

2015

European Journal of Pharmaceutics and Biopharmaceutics

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“…Oral TU has been used for androgen substitution therapy and other purposes in clinical treatment for more than 2 decades (1-6). Oral TU has also been tested as a possible contraceptive alone or in combination with cyproterone acetate (CPA) for male fertility control (7,8). The frequency of administration, fluctuation of serum T levels, and insufficient suppression of gonadotropins and spermatogenesis render an oral TU regimen impractical for male hormonal contraception.…”

mentioning

confidence: 99%

A Clinical Trial of Injectable Testosterone Undecanoate as a Potential Male Contraceptive in Normal Chinese Men

Zhang¹

1999

Journal of Clinical Endocrinology & Metabolism

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This is a pilot dose-finding study of spermatogenic suppression using testosterone undecanoate (TU) injections alone in normal Chinese men. Thirty-two healthy men were recruited. Volunteers underwent pretreatment evaluation, then a treatment period in which group I (n ϭ 13) received 500 mg TU, group II (n ϭ 12) received 1000 mg TU, and group III (n ϭ 7) received placebo, respectively, at monthly intervals during the treatment period (or until azoospermia was achieved). Thereafter, they underwent a recovery period until all parameters returned to pretreatment levels. Eleven of 12 volunteers in the 500-mg TU group, and all volunteers in the 1000-mg TU group became azoospermic. Faster suppression of spermatogenesis was achieved in the 1000-mg TU group. Serum testosterone increased significantly in the higher dose group at weeks 8 and 12, but remained within the normal range. Mean serum LH and FSH were profoundly suppressed by both doses to undetectable levels at week 16. TU injections did not cause a significant change in high density lipoprotein cholesterol levels. No serious side-effects were found. We conclude that both dosages of TU can effectively, safely, and reversibly suppress spermatogenesis in normal Chinese men. (J Clin Endocrinol Metab 84: [3642][3643][3644][3645][3646][3647] 1999) T ESTOSTERONE undecanoate (TU; 17-hydroxy-4-androsten-3-one 17-undecanoate) is an unsaturated, aliphatic, fatty acid ester of testosterone (T) that is partially absorbed via the gut lymphatic system after oral administration. Oral TU has been used for androgen substitution therapy and other purposes in clinical treatment for more than 2 decades (1-6). Oral TU has also been tested as a possible contraceptive alone or in combination with cyproterone acetate (CPA) for male fertility control (7,8). The frequency of administration, fluctuation of serum T levels, and insufficient suppression of gonadotropins and spermatogenesis render an oral TU regimen impractical for male hormonal contraception. These previous studies indicated that an oral TU regimen alone or in combination with CPA was not sufficiently effective in spermatogenic suppression.A number of clinical approaches to male hormonal contraception with T esters given alone or in combination with additional gonadotropin-suppressive agents have been investigated (9 -12). In these studies weekly im injections of T enanthate (TE) were required for consistent suppression of gonadotropins and androgen replacement. Moreover, to attain physiological mean T levels, it is necessary to accept fluctuations in circulating T levels between injections, sometimes causing unwanted side-effects. These disadvantages hindered the acceptability of these regimens and highlighted the need for long acting preparations of T with more stable delivery kinetics. Crystalline T pellet implants that produce sustained elevation of serum T for 6 months and suppress gonadotropin levels were evaluated in clinical trials. When six 200-mg T pellet implants were administered to normal Caucasian men,...

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Clinical trial with testosterone undecanoate for male fertility control

Cited by 70 publications

References 8 publications

An oral regimen of cyproterone acetate and testosterone undecanoate for spermatogenic suppression in men

An oral regimen of cyproterone acetate and testosterone undecanoate for spermatogenic suppression in men

Transdermal delivery of testosterone

A Clinical Trial of Injectable Testosterone Undecanoate as a Potential Male Contraceptive in Normal Chinese Men

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