30 Participants Needed

Oral Testosterone Undecanoate for Low Libido

SW
CG
Overseen ByClaudia Gardner, BA
Age: 18+
Sex: Female
Trial Phase: Phase 2
Sponsor: San Diego Sexual Medicine
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

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?

Oral testosterone undecanoate has been used for over 20 years and is generally considered safe for treating low testosterone levels. Some studies have reported side effects, mainly related to the digestive system, but overall, it has a good safety profile when used as directed.12456

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

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

I have been in a committed relationship for at least 6 months.
Participant provides written informed consent and HIPAA authorization before any study procedures are conducted
I am female.
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Exclusion Criteria

Participant has a history of substance abuse within 12 months prior to signing consent
Participant has received an investigational drug within 30 days prior to signing consent
Participant has any condition or exhibits behavior that indicates to the Principal Investigator that the subject is unlikely to be compliant with study procedures and visits
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Timeline

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

Treatment

Participants receive 50 mg oral testosterone undecanoate daily for 3 months

12 weeks
Visits on days 0, 7, 28, 56, and 84

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

Treatment Details

Interventions

  • Oral Testosterone Undecanoate
Trial OverviewThe trial tests Oral Testosterone Undecanoate (Kyztrex) at a single center. Participants take daily capsules for three months with regular blood tests to monitor safety and how the body processes the hormone.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: ActiveExperimental Treatment1 Intervention
Participants will receive 50mg oral testosterone undecanoate daily, have pharmacokinetics assessed and complete validated instruments

Find a Clinic Near You

Who Is Running the Clinical Trial?

San Diego Sexual Medicine

Lead Sponsor

Trials
5
Recruited
130+

Findings from Research

Injectable testosterone undecanoate (Nebido) effectively maintains stable testosterone levels in hypogonadal patients, requiring only 4-5 injections per year compared to 16 for conventional testosterone treatments, making it a more convenient option.
In hypogonadal patients with erectile dysfunction, 58% showed improvement with testosterone undecanoate, particularly benefiting diabetic patients, indicating its efficacy in this specific population.
Clinical experience with the new long-acting injectable testosterone undecanoate. Report on the educational symposium on the occasion of the 5th World Congress on the Aging Male, 9-12 February 2006, Salzburg, Austria.Morales, A., Nieschlag, E., Schubert, M., et al.[2018]
In a study involving 76 hypogonadal males, testosterone undecanoate administered orally for 9 weeks was effective in 60 out of 66 patients who completed the trial, indicating its efficacy in treating male hypogonadism.
The treatment led to a significant increase in plasma testosterone levels, with a positive correlation between plasma testosterone and testosterone undecanoate levels, although some patients experienced gastrointestinal side effects.
Clinical efficacy of testosterone undecanoate in male hypogonadism.Maisey, NM., Bingham, J., Marks, V., et al.[2019]
Testosterone undecanoate offers a more stable and effective treatment for androgen deficiency compared to traditional injectable testosterone, with injections spaced 12 weeks apart after an initial loading phase, maintaining plasma testosterone levels within the normal range.
This new formulation has an excellent safety profile, showing no adverse effects on blood parameters, lipid profiles, or prostate health, while effectively reversing symptoms of hypogonadism in bone, muscle, and sexual function.
Testosterone depot injection in male hypogonadism: a critical appraisal.Yassin, AA., Haffejee, M.[2021]

References

[Testosterone undecanoate for late -onset hypogonadism: an update]. [2014]
A new oral testosterone undecanoate formulation. [2018]
Clinical experience with the new long-acting injectable testosterone undecanoate. Report on the educational symposium on the occasion of the 5th World Congress on the Aging Male, 9-12 February 2006, Salzburg, Austria. [2018]
Clinical efficacy of testosterone undecanoate in male hypogonadism. [2019]
Efficacy and safety of two different testosterone undecanoate formulations in hypogonadal men with metabolic syndrome. [2018]
Testosterone depot injection in male hypogonadism: a critical appraisal. [2021]
Hypogonadal men treated with oral testosterone undecanoate. [2019]