**Key Findings:**
* Oral testosterone undecanoate raised serum testosterone levels to **450 ng/dL in 92% of participants**.
* Significant and clinically meaningful improvements were observed in **sexual activity scores by day 105**.
A phase 3 subanalysis presented at the **Androgen Society annual meeting** showed that oral testosterone undecanoate (marketed as **Jatenzo by Tolmar**) was effective in increasing testosterone levels and enhancing sexual activity in men diagnosed with **hypogonadism**.
The **inTUne trial** compared the safety and effectiveness of oral testosterone undecanoate with topical testosterone formulations. This marks an important advancement, since the **FDA first approved Jatenzo in March 2019**, making it the first oral testosterone therapy in over six decades. Since then, other oral testosterone products, such as **Tlando (Verity Pharmaceuticals)** and **Kyzatrex (Marius Pharmaceuticals)**, have also gained FDA approval (2022).
### Trial Design
* **Participants:** 222 men with hypogonadism.
* **Randomization:** 3:1 ratio – **Jatenzo (n = 166)** twice daily vs. **topical testosterone (n = 56)** once daily.
* **Duration:** 105 days.
* **Assessments:** Testosterone levels measured at days 21, 56, and 105 (4 hours post-dose). Sexual function was assessed using the **Psychosexual Daily Questionnaire-4 (PDQ-4)** and eight additional PDQ domains.
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### Outcomes
* **Serum Testosterone Levels:**
* At **day 21**, 93% of men on Jatenzo achieved serum testosterone ≥300 ng/dL.
* At **day 105**, this rose to 99%.
* Levels ≥450 ng/dL were achieved by **68% of participants at day 21** and **92% by day 105**.
* **Sexual Activity:**
* Mean sexual activity scores improved from **2.43 at baseline to 4.28 at day 105** (a **1.85-point gain**).
* For context, the **TRAVERSE trial** showed about a **1-point improvement**, indicating Jatenzo’s superior impact.
* **Sexual Function Domains:**
Men on Jatenzo showed notable improvements across all eight PDQ domains between baseline and day 105:
* Sexual desire: **+1.7 points**
* Highest sexual pleasure without a partner: **+1.13 points**
* Highest sexual pleasure with a partner: **+1.1 points**
* Ability to maintain erection: **+1.32 points**
* Positive mood: **+0.62 points**
* Negative mood reduction: **–0.52 points** (fewer negative mood symptoms)
* Percentage of time with full erection: improved from **59% to 74%**
Importantly, **men treated with topical testosterone** also experienced similar improvements across the PDQ domains, showing both approaches are effective, though oral therapy offers the added advantage of convenience.
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### Expert Commentary
Dr. **Mohit Khera**, Professor of Urology at **Baylor College of Medicine**, noted that while injectable testosterone therapies have long been established, **oral testosterone is still relatively new in the U.S.**, and robust clinical data regarding its impact on sexual function are just emerging.
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### References & Funding
* Trial data were presented by **Khera M, et al.** at the **Androgen Society Annual Meeting (San Francisco, July 10–11, 2025)**.
* Safety profile and trial details are available on the official **Jatenzo HCP website**.
* The study was funded by **Tolmar**. At the time of reporting,
