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

Part of paid clinical trials in San Diego, California.

Sponsor
San Diego Sexual Medicine
Study ID
NCT06082817
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Hypoactive Sexual Desire Disorder

Eligibility Criteria

Sex
FEMALE
Age
21 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • Oral Testosterone Undecanoate — DRUG
    50mg oral testosterone undecanoate daily

Study Details

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).

Key Dates

Start date
Jan 1, 2025
Status verified
Nov 2024
Primary completion
Dec 31, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Active
    Participants will receive 50mg oral testosterone undecanoate daily, have pharmacokinetics assessed and complete validated instruments

Primary Outcome Measure

Testosterone [ Time Frame: days 0, 7, 28, 56 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
San Diego Sexual MedicineSan DiegoCalifornia92120-

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San Diego Sexual Medicine· San Diego, CA

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