Two-Year Analysis of a New Oral Testosterone Undecanoate (TU) Formulation in Hypogonadal Men: Efficacy, Impact on Psychosexual Function, and Safety.

Oral testosterone undecanoate maintained eugonadal total serum testosterone concentrations over 2 years of treatment.

• Mean ± SD total serum T concentrations were 617 ± 427 ng/dL (21 ± 15 nmol/L) over 2 years
• Values remained within the eugonadal range of 300–1,000 ng/dL (10–35 nmol/L)
• Total serum T concentrations increased significantly from baseline (P < .0001)
• Study population consisted of hypogonadal men aged 18–75 years (mean age 56.2; 87.2% white)

Oral TU significantly improved all psychosexual function domains as measured by the Psychosexual Daily Questionnaire (PDQ) over 2 years.

• Mean score changes versus baseline for all PDQ domains at all time points were significantly improved (P < .0011 for all)
• For sexual activity and sexual desire components, patient scores were consistently greater than validated thresholds for clinically meaningful change
• Sexual function was assessed using the Psychosexual Daily Questionnaire (PDQ)

Oral TU was associated with a statistically significant increase in systolic blood pressure of 3–6 mm Hg.

• Systolic blood pressure increased by 3–6 mm Hg from baseline (P < .05)
• This was characterized as a typical T-induced safety change
• Cardiovascular endpoints were monitored as part of the safety assessment over 24 months

Oral TU caused a slight but statistically significant increase in hematocrit that remained below 48% throughout the study.

• Hematocrit increase was statistically significant (P < .0001)
• Hematocrit stayed below 48% throughout the entire 2-year study period
• This was characterized as a typical T-induced safety change

Oral TU was associated with a significant decrease in high-density lipoprotein (HDL) cholesterol from baseline.

• HDL cholesterol decreased by -9.8 ± 0.9 mg/dL from baseline (P < .0001)
• This was characterized as a typical T-induced safety change
• No other clinically significant cardiovascular changes were reported

There were no clinically significant changes in liver function tests or prostate-specific antigen levels over 2 years of oral TU treatment.

• No clinically significant changes from baseline in liver function tests were observed
• No clinically significant changes in prostate-specific antigen (PSA) levels were found
• Absence of liver toxicity is notable given prior concerns about oral testosterone formulations
• Liver function tests and prostate health were monitored throughout the 24-month study

Of 129 eligible TU-treated subjects from the initial 12-month trial, 86 enrolled in the extension study and 69 completed 24 months of uninterrupted oral TU therapy.

• 129 subjects who completed the original 12-month open-label, multicenter, randomized, active-controlled trial were eligible
• 86 of 129 eligible subjects (66.7%) chose to enroll in the 12-month extension study
• 69 of 86 enrolled subjects completed the full 24 months of uninterrupted oral TU therapy
• The original trial was a 12-month, open-label, multicenter, randomized, active-controlled study