Oral Testosterone Undecanoate for Low Libido
Trial Summary
What is the purpose of this trial?
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).
Will I have to stop taking my current medications?
The trial protocol does not specify if you must stop taking your current medications, but you cannot take any form of testosterone other than the study drug during the trial. Additionally, you cannot take any medication listed in Appendix 1 from 30 days before starting the study drug until the end of the study.
What data supports the effectiveness of the drug Oral Testosterone Undecanoate for low libido?
Testosterone undecanoate has been shown to improve libido (sexual desire) in men with low testosterone levels, as it effectively increases testosterone levels in the body. Studies have demonstrated its efficacy in treating symptoms associated with reduced testosterone, including improved libido, in men with conditions like hypogonadism (a condition where the body doesn't produce enough testosterone).12345
Is oral testosterone undecanoate safe for humans?
How does the drug oral testosterone undecanoate differ from other treatments for low libido?
Oral testosterone undecanoate is unique because it is taken by mouth, unlike traditional testosterone treatments that are often injected. This oral form is designed to maintain stable testosterone levels without the 'roller coaster' effect seen with injections, making it more convenient and potentially more comfortable for patients.12467
Research Team
Irwin Goldstein, MD
Principal Investigator
San Diego Sexual Medicine
Eligibility Criteria
This trial is for menopausal women with low testosterone and HSDD who are in a stable relationship, have a BMI ≤ 35 kg/m2, and experience symptoms of low testosterone. They must be over 21 years old, agree to study procedures, and not have certain health conditions or sensitivities to the medication's ingredients.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive 50 mg oral testosterone undecanoate daily for 3 months
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Oral Testosterone Undecanoate
Find a Clinic Near You
Who Is Running the Clinical Trial?
San Diego Sexual Medicine
Lead Sponsor