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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).
This study is being conducted in an unblinded fashion because the primary endpoint is pharmacokinetic information, and all subjects will receive the same active drug at the same dosage. The primary objectives of this study are to assess the short-term safety and to investigate the pharmacokinetics of serum concentration of total testosterone with daily administration of one (1) 50 mg capsule of testosterone undecanoate (Kyzatrax®) in thirty menopausal women with hypoactive sexual desire disorder (HSDD) and low testosterone. The secondary objective of this study is to assess the efficacy of daily oral administration of one (1) 50 mg capsule of testosterone undecanoate (Kyzatrax®) in thirty menopausal women with HSDD and low testosterone.
The eligibility criterion for testosterone concentration (< 25 ng/mL [< 0.87 nmol/L]) is based on the lower limit of the normal testosterone reference range for adult females. The dose of 50 mg was chosen because this is the lowest oral testosterone currently being manufactured and it represents 12.5% of the starting dose of Kyzatrex FDA approved for men (see Attachment 1). Based on the guidelines of the International Society for the Study of Women's Sexual Health, the starting dose of testosterone for peri- and post-menopausal women is approximately 10% of a testosterone product FDA approved for men. In clinical practice, women are typically prescribed testosterone therapy at 10-20% of the dose given to men, depending on individual adsorption and metabolism characteristics.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active | Experimental | Participants will receive 50mg oral testosterone undecanoate daily, have pharmacokinetics assessed and complete validated instruments |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral Testosterone Undecanoate | Drug | 50mg oral testosterone undecanoate daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Testosterone | serum concentration of total testosterone to assess safety (adverse events) and pharmacokinetics | days 0, 7, 28, 56 |
| Measure | Description | Time Frame |
|---|---|---|
| Female Sexual Function Index | Female Sexual Function Index to assess changes in each domain and total, total range 2-36, lower the score the more dysfunction therefore worse function | Days 0, 28, 56, 84 |
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Inclusion Criteria:
Exclusion Criteria:
Cis-gender female identifying as a female
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sue W Goldstein, BA | Contact | 619-265-8865 | suewgoldstein@gmail.com | |
| Claudia Gardner, BA | Contact | 619-265-8865 | cgardner@sdsm.info |
| Name | Affiliation | Role |
|---|---|---|
| Irwin Goldstein, MD | San Diego Sexual Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Diego Sexual Medicine | San Diego | California | 92120 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29545008 | 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. | |
| 33814355 |
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| ID | Term |
|---|---|
| D020018 | Sexual Dysfunctions, Psychological |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C010792 | testosterone undecanoate |
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Open label 50mg daily dosing with pharmacokinetics assessed by multiple blood draws
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| 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. |
| 11937111 | 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. |
| 26358173 | 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. |
| 34114726 | 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. |
| 36268410 | 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. |