NCT06082817

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

An Open-Label Pilot Study of the Pharmacokinetics and Safety of 50 Mg Oral Testosterone Undecanoate (Kyzatrex) in Menopausal Women with Low Testosterone and Hypoactive Sexual Desire Disorder

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: San Diego Sexual Medicine · Academic / Other
• Sex: Female
• Age: 21 Years – 75 Years
• Healthy volunteers: Accepted

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).

Detailed description

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.

Conditions

• Hypoactive Sexual Desire Disorder

Interventions

Type	Name	Description
DRUG	Oral Testosterone Undecanoate	50mg oral testosterone undecanoate daily

Timeline

• Start date: 2025-01-01
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2023-10-13
• Last updated: 2024-11-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study