Oral Testosterone Undecanoate for Low Libido

Overseen By Claudia Gardner, BA

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: San Diego Sexual Medicine

Must not be taking: Testosterone

Disqualifiers: Breast cancer, Heart attack, Stroke, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an oral testosterone treatment to determine its effectiveness for women with hypoactive sexual desire disorder. Researchers aim to understand how the body processes this testosterone capsule and assess its safety. Women who are menopausal, have low testosterone levels, and experience low libido may qualify for this study. Participants will take the testosterone capsule daily for three months, with regular check-ups and blood tests to monitor progress and safety. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group.

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.

Is there any evidence suggesting that oral testosterone undecanoate is likely to be safe for humans?

Research has shown that oral testosterone undecanoate is usually well-tolerated. In previous studies, patients using this treatment for low testosterone levels experienced improvements in sex drive and sexual activity without serious side effects. Another study found that long-term use of oral testosterone undecanoate can be safe and effective for men. Although these studies examined higher doses, the results suggest that lower doses, like those in the current trial, are also safe. Participants in earlier trials did not report major negative effects, indicating the treatment's safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike standard treatments for low libido, which often involve topical gels, injections, or patches, oral testosterone undecanoate offers a convenient pill form. This oral administration is a game-changer because it simplifies the treatment process, potentially improving patient compliance. Additionally, the pharmacokinetics of testosterone undecanoate may provide a more stable release of testosterone, which could result in more consistent symptom relief. Researchers are excited about these features as they could enhance the overall effectiveness and accessibility of testosterone therapy for those with low libido.

What evidence suggests that oral testosterone undecanoate might be an effective treatment for low libido?

Research shows that oral testosterone undecanoate can increase sex drive in men with low testosterone. Studies have found it helps maintain normal testosterone levels and improves sexual function. For example, one study noted a significant increase in men's sexual activity scores after using the treatment. Another study found that men experienced a higher sex drive and more frequent sexual activity with oral testosterone undecanoate. Overall, this treatment is considered a safe and effective way to address low sex drive caused by low testosterone. ^{2 3 4 6 7}

Who Is on the Research Team?

Irwin Goldstein, MD

Principal Investigator

San Diego Sexual Medicine

Are You a Good Fit for This Trial?

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.

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Oral Testosterone Undecanoate

Trial Overview The 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.

How Is the Trial Designed?

Group I: Active Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

San Diego Sexual Medicine

Lead Sponsor

Trials

5

Recruited

130+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical efficacy of testosterone undecanoate in male hypogonadism. Maisey, NM., Bingham, J., Marks, V., et al.[2019]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Testosterone depot injection in male hypogonadism: a critical appraisal. Yassin, AA., Haffejee, M.[2021]

In a study involving three hypogonadal male subjects, oral testosterone undecanoate (120 mg daily for 3 weeks) effectively raised plasma testosterone levels to normal ranges, demonstrating its efficacy as a replacement therapy.

The treatment also led to increased levels of plasma androstenedione and a reduction in sex hormone binding globulin, with patients reporting satisfactory clinical responses, indicating a positive impact on their health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypogonadal men treated with oral testosterone undecanoate. Sarris, S., Swyer, GI., Lawrence, DM.[2019]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36272969/

Efficacy, Impact on Psychosexual Function, and Safety Conclusion: Oral TU offers a safe and effective long-term treatment option for men with hypogonadism. Honig S, Gittelman M, Kaminetsky J, et al.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1743609522017805

Two-Year Analysis of a New Oral Testosterone ... Over 2 years of treatment, this novel oral TU formulation maintained total T concentrations in mideugonadal ranges, with improvements in sexual function and no ...

3. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/andr.13747

Safety, efficacy, and pharmacokinetics of oral testosterone ... Male patients with hypogonadism receiving oral testosterone undecanoate 225 mg twice daily demonstrated improvements in libido and sexual frequency.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT01403116

Safety and Efficacy Trial of Oral Testosterone Undecanoate ... The purpose of this study is to determine the safety and efficacy of an oral testosterone undecanoate formulation for use as testosterone-replacement therapy in ...

5. healio.com healio.com/news/endocrinology/20250821/oral-testosterone-therapy-improves-sexual-activity-for-men

Oral testosterone therapy improves sexual activity for men Mean sexual activity scores rose from 2.43 points at baseline to 4.28 points at day 105 for men receiving oral testosterone undecanoate, a 1.85- ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12006877/

Safety, efficacy, and pharmacokinetics of oral testosterone ... Male patients with hypogonadism receiving oral testosterone undecanoate 225 mg twice daily demonstrated improvements in libido and sexual frequency.

7. academic.oup.com academic.oup.com/jsm/article/21/Supplement_7/qdae167.130/7919025

(133) ORAL TESTOSTERONE UNDECANOATE QUICKLY ... Negative effects associated with hypogonadism include development of metabolic syndrome, increased risk of coronary artery disease, decreased libido, low bone ...