An Open-Label Study of 50 Mg Oral Testosterone Undecanoate (Kyztrex) in Menopausal Women with Low Testosterone and HSDD

Summary

This is an unblinded study to be conducted at a single research center, San Diego Sexual Medicine. Eligible subjects will receive 50 mg capsules of Kyzatrax® to be taken orally daily over a 3-month period. Multiple blood samples will be taken at baseline and on days 7, 28 and 56 to assess safety and pharmacokinetics of the testosterone. After the informed consent is signed and for up to 14 days after the last dose of study drug, participants will have serial blood samples collected in addition to other routine study procedures (e.g. vital signs measured, adverse events assessed, validated outcome scales completed).

Timeline

Start

2025-01-01

Primary completion

2025-12-31

Completion

2025-12-31

Publications

• Background Clayton AH, Goldstein I, Kim NN, Althof SE, Faubion SS, Faught BM, Parish SJ, Simon JA, Vignozzi L, Christiansen K, Davis SR, Freedman MA, Kingsberg SA, Kirana PS, Larkin L, McCabe M, Sadovsky R. The International Society for the Study of Women's Sexual Health Process of Care for Management of Hypoactive Sexual Desire Disorder in Women. Mayo Clin Proc. 2018 Apr;93(4):467-487. doi: 10.1016/j.mayocp.2017.11.002. Epub 2018 Mar 12.
• Background Parish SJ, Simon JA, Davis SR, Giraldi A, Goldstein I, Goldstein SW, Kim NN, Kingsberg SA, Morgentaler A, Nappi RE, Park K, Stuenkel CA, Traish AM, Vignozzi L. International Society for the Study of Women's Sexual Health Clinical Practice Guideline for the Use of Systemic Testosterone for Hypoactive Sexual Desire Disorder in Women. J Sex Med. 2021 May;18(5):849-867. doi: 10.1016/j.jsxm.2020.10.009. Epub 2021 Apr 1.
• Background Bachmann G, Bancroft J, Braunstein G, Burger H, Davis S, Dennerstein L, Goldstein I, Guay A, Leiblum S, Lobo R, Notelovitz M, Rosen R, Sarrel P, Sherwin B, Simon J, Simpson E, Shifren J, Spark R, Traish A; Princeton. Female androgen insufficiency: the Princeton consensus statement on definition, classification, and assessment. Fertil Steril. 2002 Apr;77(4):660-5. doi: 10.1016/s0015-0282(02)02969-2.
• Background Davis SR, Wahlin-Jacobsen S. Testosterone in women--the clinical significance. Lancet Diabetes Endocrinol. 2015 Dec;3(12):980-92. doi: 10.1016/S2213-8587(15)00284-3. Epub 2015 Sep 7.
• Background White WB, Bernstein JS, Rittmaster R, Dhingra O. Effects of the oral testosterone undecanoate Kyzatrex on ambulatory blood pressure in hypogonadal men. J Clin Hypertens (Greenwich). 2021 Jul;23(7):1420-1430. doi: 10.1111/jch.14297. Epub 2021 Jun 11.
• Background Asghar AA, Hashmi MR, Ahmed R, Khabir Y. Kyzatrex - Oral testosterone replacement therapy. Ann Med Surg (Lond). 2022 Sep 11;82:104625. doi: 10.1016/j.amsu.2022.104625. eCollection 2022 Oct. No abstract available.

Drugs

Indications