Safety and Pharmacokinetics of Single-Dose Novel Oral Androgen 11<i>β</i>-Methyl-19-Nortestosterone-17<i>β</i>-Dodecylcarbonate in Men

Wu, Sherry Y.; Yuen, Fiona; Swerdloff, Ronald S.; Pak, Youngju; Thirumalai, Arthi; Liu, Peter Y; Amory, John K.; Feng, Baili; Hull, Laura; Blithe, Diana L.; Anawalt, Bradley D.; Parman, Toufan; Kim, Kyuri; Lee, Min S.; Bremner, William J.; Page, Stephanie T.; Wang, Christina

doi:10.1210/jc.2018-01528

Cited by 40 publications

(20 citation statements)

References 40 publications

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“…In preclinical data, it showed serum gonadotropin suppression, 30 and one study in men demonstrated that given in oral doses of 100-800 mg with food it is well tolerated and able to suppress testosterone. 31 6 journals.sagepub.com/home/tae…”

Section: Hormonal Contraceptive Transdermal Regimes Using Testosterone and Nestorone: Gel-gel Combinationmentioning

confidence: 99%

Update on male hormonal contraception

Gava

Meriggiola

2019

Therapeutic Advances in Endocrinology

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Despite increases in female contraceptive options, 40–45% of pregnancies across the world are still unplanned. While several effective female contraceptive methods have been developed, contraceptive choices for men are still limited to the male condom with its high failure rates and to vasectomies, which are invasive and not reliably reversible. Several studies have demonstrated a great interest among men and women for effective, reversible, and safe male contraceptive methods. Over the years, numerous studies have been performed to develop male hormonal and nonhormonal safe and effective contraceptives. A variety of new molecules are under development as oral or transdermal hormonal contraceptives for men demonstrating few side effects. In our overpopulated world, the development and commercialization of a male contraceptive method that will allow both men and women to take an active role in family planning is mandatory and further research on this topic is required.

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Section: Hormonal Contraceptive Transdermal Regimes Using Testosterone and Nestorone: Gel-gel Combinationmentioning

confidence: 99%

Update on male hormonal contraception

Gava

Meriggiola

2019

Therapeutic Advances in Endocrinology

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“…Current development includes long-acting injectables and transdermal gels. Novel androgens that may have both androgenic and progestational activities are also part of the search for a single-agent male hormonal contraceptive method [ 11 , 12 ]. At the moment, however, the lack of long-term studies has precluded the development of a marketable product.…”

Section: Introductionmentioning

confidence: 99%

Testis-specific serine kinase protein family in male fertility and as targets for non-hormonal male contraception†

Salicioni

Gervasi

Sosnik

et al. 2020

Biology of Reproduction

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Male contraception is a very active area of research. Several hormonal agents have entered clinical trials, while potential non-hormonal targets have been brought to light more recently and are at earlier stages of development. The general strategy is to target genes along the molecular pathways of sperm production, maturation, or function, and it is predicted that these novel approaches will hopefully lead to more selective male contraceptive compounds with a decreased side effect burden. Protein kinases are known to play a major role in signaling events associated with sperm differentiation and function. In this review, we focus our analysis on the testis-specific serine kinase (TSSK) protein family. We have previously shown that members of the family of TSSKs are postmeiotically expressed in male germ cells and in mature mammalian sperm. The restricted postmeiotic expression of TSSKs as well as the importance of phosphorylation in signaling processes strongly suggests that TSSKs have an important role in germ cell differentiation and/or sperm function. This prediction has been supported by the reported sterile phenotype of the Tssk6 knockout (KO) mice and of the double Tssk1 and Tssk2 KO mice and by the male subfertile phenotype observed in a Tssk4 KO mouse model. Summary Sentence The established role of TSSKs in spermiogenesis and in male fertility, together with their unique kinase features, strongly supports this family of protein kinases as a very promising drug discovery target for development of a non-hormonal male contraceptive.

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“…There are various ongoing studies to develop these drugs, both as implantable and oral contraceptives. Recently, phase I trials of two oral preparations, 11-beta-methyl-19-nortestosterone dodecylcarbonate19 and dimethandrolone undecanoate,20 have been conducted showing gonadotrophin suppression and therefore promise as potential male contraceptive pills, although at a very early stage.…”

Section: Current and Future Hormonal Approachesmentioning

confidence: 99%

Male contraception: where are we going and where have we been?

Reynolds-Wright

Anderson

2019

BMJ Sex Reprod Health

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Progress in developing new reversible male contraception has been slow. While the hormonal approach has been clearly shown to be capable of providing effective and reversible contraception, there remains no product available. Currently, trials of a self-administered gel combination of testosterone and the progestogen Nestorone® are under way, complementing the largely injectable methods previously investigated. Novel long-acting steroids with both androgenic and progestogenic activity are also in early clinical trials. The non-hormonal approach offers potential advantages, with potential sites of action on spermatogenesis, and sperm maturation in the epididymis or at the vas, but remains in preclinical testing. Surveys indicate the willingness of men, and their partners, to use a new male method, but they continue to lack that opportunity.

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Safety and Pharmacokinetics of Single-Dose Novel Oral Androgen 11β-Methyl-19-Nortestosterone-17β-Dodecylcarbonate in Men

Cited by 40 publications

References 40 publications

Update on male hormonal contraception

Update on male hormonal contraception

Testis-specific serine kinase protein family in male fertility and as targets for non-hormonal male contraception†

Male contraception: where are we going and where have we been?

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