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*m 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-point improvement during the trial.
“Just to put this in perspective, when we look at the TRAVERSE trial, that change [in sexual activity score] was about 1 [point],” Khera said. “This is significantly higher.”
www.healio.com
Oral testosterone undecanoate significantly improved serum testosterone levels and sexual activity among men with hypogonadism, according to a subanalysis of a phase 3 trial presented at the Androgen Society annual meeting.
The inTUne phase 3 trial was conducted to assess the safety and efficacy of oral testosterone undecanoate (Jatenzo, Tolmar) compared with topical testosterone among men with hypogonadism. As Healio previously reported, the FDA approved Jatenzo in March 2019 for men with some forms of hypogonadism, making it the first oral testosterone to receive FDA approval in more than 60 years at the time. The FDA has since approved other oral testosterone therapy products, including Tlando (Verity Pharmaceuticals) and Kyzatrex (Marius Pharmaceuticals) in 2022.
Data were derived from Khera M, et al. Oral testosterone undecanoate effectively increases serum testosterone and improves sexual activity in hypogonadal men. Presented at: Androgen Society Annual Meeting; July 10-11, 2025; San Francisco.“In the United States, oral testosterone is a relatively new phenomenon,” Mohit Khera, MD, MBA, MPH, the F. Brantley Scott Chair in Urology and director of the Laboratory for Andrology Research at Baylor College of Medicine, said during a presentation. “While we have very good data on oral testosterone undecanoate injectables, we have very little data on oral testosterone undecanoate in terms of sexual function.”
The inTUne trial enrolled 222 men with hypogonadism. Participants were randomly assigned, 3:1, to twice-daily Jatenzo (n = 166) or a once-daily topical testosterone product (n = 56) for 105 days. Testosterone levels were collected 4 hours post-dose at days 21, 56 and 105. The Psychosexual Daily Questionnaire-4 (PDQ-4) was conducted to assess sexual desire at day 1 and day 105. Researchers also analyzed eight other individual PDQ domains, including overall sexual level, sexual pleasure with and without partner, positive mood, negative mood, sexual activity, percentage of full erection and whether erection was satisfactorily maintained.
There were 154 men who received Jatenzo and had full serum testosterone data available. Of that group, 93% had a serum testosterone of 300 ng/dL or higher at day 21, and 99% achieved a serum testosterone of 300 ng/dL or greater at day 105. Serum testosterone of 450 ng/dL or higher was achieved by 68% of men at day 21 and 92% of men at day 105.
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-point improvement during the trial.
“Just to put this in perspective, when we look at the TRAVERSE trial, that change [in sexual activity score] was about 1 [point],” Khera said. “This is significantly higher.”
All individual sexual activity domains significantly improved during the study with oral testosterone. From baseline to day 105, participants had a 1.7-point increase in sexual desire, a 1.13-point rise in highest sexual pleasure without a partner, a 1.1-point increase in highest sexual pleasure with a partner, a 1.32-point increase in maintaining an erection, a 0.62-point raise in positive mood and a 0.52-point decrease in negative mood, which Khera said indicated fewer negative mood symptoms. The percentage of time with full erection also significantly improved from 59% at baseline to 74% at day 105.
Khera added that men receiving topical testosterone in the study had similar improvements in all eight PDQ domains as those receiving oral testosterone undecanoate.
“Just to put this in perspective, when we look at the TRAVERSE trial, that change [in sexual activity score] was about 1 [point],” Khera said. “This is significantly higher.”
Oral testosterone therapy improves sexual activity for men
Oral testosterone undecanoate significantly improved serum testosterone levels and sexual activity among men with hypogonadism, according to a subanalysis of a phase 3 trial presented at the Androgen Society annual meeting. The inTUne phase 3 trial was conducted to assess the safety and efficacy...
www.healio.com
Oral testosterone undecanoate significantly improved serum testosterone levels and sexual activity among men with hypogonadism, according to a subanalysis of a phase 3 trial presented at the Androgen Society annual meeting.
The inTUne phase 3 trial was conducted to assess the safety and efficacy of oral testosterone undecanoate (Jatenzo, Tolmar) compared with topical testosterone among men with hypogonadism. As Healio previously reported, the FDA approved Jatenzo in March 2019 for men with some forms of hypogonadism, making it the first oral testosterone to receive FDA approval in more than 60 years at the time. The FDA has since approved other oral testosterone therapy products, including Tlando (Verity Pharmaceuticals) and Kyzatrex (Marius Pharmaceuticals) in 2022.
Data were derived from Khera M, et al. Oral testosterone undecanoate effectively increases serum testosterone and improves sexual activity in hypogonadal men. Presented at: Androgen Society Annual Meeting; July 10-11, 2025; San Francisco.“In the United States, oral testosterone is a relatively new phenomenon,” Mohit Khera, MD, MBA, MPH, the F. Brantley Scott Chair in Urology and director of the Laboratory for Andrology Research at Baylor College of Medicine, said during a presentation. “While we have very good data on oral testosterone undecanoate injectables, we have very little data on oral testosterone undecanoate in terms of sexual function.”
The inTUne trial enrolled 222 men with hypogonadism. Participants were randomly assigned, 3:1, to twice-daily Jatenzo (n = 166) or a once-daily topical testosterone product (n = 56) for 105 days. Testosterone levels were collected 4 hours post-dose at days 21, 56 and 105. The Psychosexual Daily Questionnaire-4 (PDQ-4) was conducted to assess sexual desire at day 1 and day 105. Researchers also analyzed eight other individual PDQ domains, including overall sexual level, sexual pleasure with and without partner, positive mood, negative mood, sexual activity, percentage of full erection and whether erection was satisfactorily maintained.
There were 154 men who received Jatenzo and had full serum testosterone data available. Of that group, 93% had a serum testosterone of 300 ng/dL or higher at day 21, and 99% achieved a serum testosterone of 300 ng/dL or greater at day 105. Serum testosterone of 450 ng/dL or higher was achieved by 68% of men at day 21 and 92% of men at day 105.
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-point improvement during the trial.
“Just to put this in perspective, when we look at the TRAVERSE trial, that change [in sexual activity score] was about 1 [point],” Khera said. “This is significantly higher.”
All individual sexual activity domains significantly improved during the study with oral testosterone. From baseline to day 105, participants had a 1.7-point increase in sexual desire, a 1.13-point rise in highest sexual pleasure without a partner, a 1.1-point increase in highest sexual pleasure with a partner, a 1.32-point increase in maintaining an erection, a 0.62-point raise in positive mood and a 0.52-point decrease in negative mood, which Khera said indicated fewer negative mood symptoms. The percentage of time with full erection also significantly improved from 59% at baseline to 74% at day 105.
Khera added that men receiving topical testosterone in the study had similar improvements in all eight PDQ domains as those receiving oral testosterone undecanoate.
