madman
Super Moderator
Author Block: Martin Miner, M.D1, Lena Yoo, PharmD2, Zuzanna Szmukier, PharmD2, Deborah Boldt-Houle, PhD2. 1Men’s Health Center, Miriam Hospital, Providence, RI, USA, 2Tolmar, Inc., Buffalo Grove, IL, USA.
Disclosure Block: M. Miner: Halozyme Therapeutics, Inc. L. Yoo: Tolmar, Inc. Z. Szmukier: Tolmar, Inc. D. Boldt-Houle:Tolmar, Inc..
Background
Over 2.4 million US men have hypogonadism, defined as serum testosterone (T) levels <300ng/dL with symptoms of T deficiency. Negative effects associated with hypogonadism include development of metabolic syndrome, increased risk of coronary artery disease, decreased libido, low bone mineral density, and muscle loss. Oral testosterone therapies (TTh) provide a route of administration that may be more appropriate for some patients’ needs. We present secondary analyses of T data from the phase 3 inTUNE study of oral titratable testosterone undecanoate (TU) which is approved in 158, 198, 237, 316, and 396mg doses, with the goal of demonstrating that oral TU doses effectively achieve and maintain normal mean serum T concentration in patients throughout the study.
Methods
A phase 3, randomized, active controlled, open-label study was conducted to assess the safety and efficacy of oral TU in 166 hypogonadal men. The initial oral TU dose was 237mg TU twice a day (BID). Titration opportunities were on Days 35 and 70 based on the 24-hour average T concentration on Days 21 and 56. 4 hours post-dose T measurements were taken before and after each titration adjustment (Days 21, 56, and 105, respectively).
Results:
55 patients had serum T data on all study days. Mean serum T at baseline was 260ng/dL. Patients achieved 4 hours post-dose mean serum T concentrations of 616, 708, and 774ng/dL by Day 21, 56, and 105, respectively. By Day 105, 40%, 32%, and 26% were on a dose of 396mg, 316mg, and 237mg, respectively to achieve target T levels. With the starting dose of 237 mg, 92% of men achieved mean serum T >300 ng/dL on day 21; with 2 titration opportunities, 99% of men achieved mean serum T >300 ng/dL.
Conclusions
This study demonstrated that oral TU effectively increased 4 hours post-dose serum T levels in hypogonadal men, with patients achieving mean serum T concentrations above 750ng/dL by Day 105. The range of titratable doses allowed for flexible treatment adjustments based on individual patient responses, providing an effective therapeutic option. Future studies and investigations should evaluate patient factors that may impact the magnitude of T increases from changes in TU doses as this would allow for more individualized titrations and guide clinicians to determine more optimal doses based on these patient factors.
Disclosure Block: M. Miner: Halozyme Therapeutics, Inc. L. Yoo: Tolmar, Inc. Z. Szmukier: Tolmar, Inc. D. Boldt-Houle:Tolmar, Inc..
Background
Over 2.4 million US men have hypogonadism, defined as serum testosterone (T) levels <300ng/dL with symptoms of T deficiency. Negative effects associated with hypogonadism include development of metabolic syndrome, increased risk of coronary artery disease, decreased libido, low bone mineral density, and muscle loss. Oral testosterone therapies (TTh) provide a route of administration that may be more appropriate for some patients’ needs. We present secondary analyses of T data from the phase 3 inTUNE study of oral titratable testosterone undecanoate (TU) which is approved in 158, 198, 237, 316, and 396mg doses, with the goal of demonstrating that oral TU doses effectively achieve and maintain normal mean serum T concentration in patients throughout the study.
Methods
A phase 3, randomized, active controlled, open-label study was conducted to assess the safety and efficacy of oral TU in 166 hypogonadal men. The initial oral TU dose was 237mg TU twice a day (BID). Titration opportunities were on Days 35 and 70 based on the 24-hour average T concentration on Days 21 and 56. 4 hours post-dose T measurements were taken before and after each titration adjustment (Days 21, 56, and 105, respectively).
Results:
55 patients had serum T data on all study days. Mean serum T at baseline was 260ng/dL. Patients achieved 4 hours post-dose mean serum T concentrations of 616, 708, and 774ng/dL by Day 21, 56, and 105, respectively. By Day 105, 40%, 32%, and 26% were on a dose of 396mg, 316mg, and 237mg, respectively to achieve target T levels. With the starting dose of 237 mg, 92% of men achieved mean serum T >300 ng/dL on day 21; with 2 titration opportunities, 99% of men achieved mean serum T >300 ng/dL.
Conclusions
This study demonstrated that oral TU effectively increased 4 hours post-dose serum T levels in hypogonadal men, with patients achieving mean serum T concentrations above 750ng/dL by Day 105. The range of titratable doses allowed for flexible treatment adjustments based on individual patient responses, providing an effective therapeutic option. Future studies and investigations should evaluate patient factors that may impact the magnitude of T increases from changes in TU doses as this would allow for more individualized titrations and guide clinicians to determine more optimal doses based on these patient factors.
