madman
Super Moderator
Introduction: Male hypogonadism is defined by a low serum testosterone (T) concentration (e.g., < 300 ng/dL) and associated symptoms. A novel oral testosterone undecanoate (TU) formulation[1] now offers hypogonadal men in the U.S. a new treatment option compared to long-standing T replacement products (e.g., intramuscular or subcutaneous injections (T-esters), subcutaneous T pellets, transdermal T-gels, buccal T patch or a nasal T-gel).
Objectives: To determine the change in sexual functioning and well-being, as measured by the Psychosexual Daily Questionnaire (PDQ)2, in hypogonadal men after treatment with an oral TU for one year.
Methods: Hypogonadal men, 18-65 y/o, were recruited into a one-year, randomized, multi-center trial. Patients were randomized to either oral TU (n=161) or T-gel (n=160). Hypogonadism was defined as two morning T concentrations < 300 ng/dL with accompanying symptoms. The starting dose of oral TU was 316 mg, BID, and was adjusted to the eugonadal range (300 to 1000 ng/dL) at two predefined time points (D45 and D105) based on serum T levels. Patients were instructed to complete the PDQ for 7 consecutive days prior to their study visits on D0 (baseline; BL), D30, D90, D180, D270, and D365. Safety measures included physical examination, vital signs, fasting clinical laboratory analyses, and prostate measures.
Results: Following oral TU administration, total T increased significantly from 208 ± 108 ng/dL (mean ± SD) at BL to 628 ± 343 ng/dL and 524 ± 215 ng/dL, at D90 and D365, respectively. Overall, 85.0% of TU-treated men achieved mid-eugonadal T levels at D365. There was a significant positive change in all PDQ variables (see Table 1). Consistent increases of > 0.7 in sexual activity and sexual desire scores (both p< 0.0001) occurred beginning on D30 and remained persistently increased over the the12-month study period. An increase of > 0.7 in sexual desire[2] and > 0.6 in sexual activity[3] is associated with clinical meaningful changes in hypogonadal older men. There were also statistically significant increases in positive mood scores (p << 0.001 at each visit) with corresponding statistically significant decreases in negative mood scores (p ≤ 0.0031 at each visit. The most common treatment-emergent adverse events were elevated hematocrit (6.8%), enlarged prostate (5.6%), peripheral edema (5.5%), and hypertension (3.7%). There was a 2.9 ± 3.8% overall increase in hematocrit (p < 0.0001), mean PSA increased 0.29 ± 0.72 (p < 0.0001) and prostate volume increased by 2.97 ± 9.8 ng/mL (p = 0.002). No change occurred in prostate symptom scores. There was an increase in cuff systolic BP of 5.1 ± 15.4 mmHg (p = 0.0003) and a significant decrease in HDL by 11.2 ± 7.94 mg/dL (p < 0.0001) when compared to BL. Notably, there were no clinically significant changes in liver or kidney function.
Conclusion: In hypogonadal men treated for 12-months with a novel oral TU formulation, clinically significant and sustained improvements in sexual symptom scores occurred beginning shortly after therapy and continued during the 12-month period. Anticipated androgen effects on hematocrit, HDL, and prostate parameters were observed.
Table 1: Effect of Oral TU on PDQ Responses over 12-Months (mean ± SD)
* Denotes statistically significant change from baseline. All values were p < 0.0001, except D BL to D270 for negative mood (p = 0.0031) and D BL to D30 positive mood (p = 0.0002).
† Denotes clinically significant change from baseline. Clinical significance is determined for a change > 0.7 for Sexual Desire or > 0.6 for Weekly Sexual Activity.
Objectives: To determine the change in sexual functioning and well-being, as measured by the Psychosexual Daily Questionnaire (PDQ)2, in hypogonadal men after treatment with an oral TU for one year.
Methods: Hypogonadal men, 18-65 y/o, were recruited into a one-year, randomized, multi-center trial. Patients were randomized to either oral TU (n=161) or T-gel (n=160). Hypogonadism was defined as two morning T concentrations < 300 ng/dL with accompanying symptoms. The starting dose of oral TU was 316 mg, BID, and was adjusted to the eugonadal range (300 to 1000 ng/dL) at two predefined time points (D45 and D105) based on serum T levels. Patients were instructed to complete the PDQ for 7 consecutive days prior to their study visits on D0 (baseline; BL), D30, D90, D180, D270, and D365. Safety measures included physical examination, vital signs, fasting clinical laboratory analyses, and prostate measures.
Results: Following oral TU administration, total T increased significantly from 208 ± 108 ng/dL (mean ± SD) at BL to 628 ± 343 ng/dL and 524 ± 215 ng/dL, at D90 and D365, respectively. Overall, 85.0% of TU-treated men achieved mid-eugonadal T levels at D365. There was a significant positive change in all PDQ variables (see Table 1). Consistent increases of > 0.7 in sexual activity and sexual desire scores (both p< 0.0001) occurred beginning on D30 and remained persistently increased over the the12-month study period. An increase of > 0.7 in sexual desire[2] and > 0.6 in sexual activity[3] is associated with clinical meaningful changes in hypogonadal older men. There were also statistically significant increases in positive mood scores (p << 0.001 at each visit) with corresponding statistically significant decreases in negative mood scores (p ≤ 0.0031 at each visit. The most common treatment-emergent adverse events were elevated hematocrit (6.8%), enlarged prostate (5.6%), peripheral edema (5.5%), and hypertension (3.7%). There was a 2.9 ± 3.8% overall increase in hematocrit (p < 0.0001), mean PSA increased 0.29 ± 0.72 (p < 0.0001) and prostate volume increased by 2.97 ± 9.8 ng/mL (p = 0.002). No change occurred in prostate symptom scores. There was an increase in cuff systolic BP of 5.1 ± 15.4 mmHg (p = 0.0003) and a significant decrease in HDL by 11.2 ± 7.94 mg/dL (p < 0.0001) when compared to BL. Notably, there were no clinically significant changes in liver or kidney function.
Conclusion: In hypogonadal men treated for 12-months with a novel oral TU formulation, clinically significant and sustained improvements in sexual symptom scores occurred beginning shortly after therapy and continued during the 12-month period. Anticipated androgen effects on hematocrit, HDL, and prostate parameters were observed.
Table 1: Effect of Oral TU on PDQ Responses over 12-Months (mean ± SD)
BL | D BL to D30 | D BL to D90 | D BL to D180 | D BL to D270 | D BL to D365 | |
Sexual Desire | 2.0 ± 1.6 | 1.4 ± 1.3*† | 1.7 ± 1.6*† | 1.7 ± 1.6*† | 1.5 ± 1.6*† | 1.5 ± 1.7*† |
Sexual Enjoyment with a Partner | 1.23 ± 1.4 | 0.88 ± 1.4* | 0.95 ± 1.7* | 1.06 ± 1.8* | 0.97 ± 1.8* | 0.92 ± 1.8* |
Negative Mood | 1.79 ± 1.3 | -0.46 ± 0.98* | -0.46 ± 1.0* | -0.39 ± 1.1* | -0.31 ± 1.2* | -0.41 ± 1.1* |
Positive Mood | 4.44 ± 1.3 | 0.35 ± 1.1* | 0.66 ± 1.2* | 0.64 ± 1.1* | 0.57 ± 1.2* | 0.52 ± 1.2* |
Weekly Sexual Activity | 1.97 ± 1.9 | 1.5 ± 1.7*† | 1.8 ± 2.4*† | 1.8 ± 2.2*† | 1.9 ± 2.4*† | 2.0 ± 2.3*† |
Satisfaction with Erection | 3.47 ± 1.9 | 0.8 ± 1.5* | 1.0 ± 1.7* | 1.1 ± 1.7* | 1.1 ± 1.6* | 0.9 ± 1.4* |
Percent Full Erection | 57.5 ± 26.2 | 9.0 ± 18.5* | 11.3 ± 22.4* | 11.4 ± 24.4* | 13.4 ± 23.6* | 10.0 ± 19.5* |
† Denotes clinically significant change from baseline. Clinical significance is determined for a change > 0.7 for Sexual Desire or > 0.6 for Weekly Sexual Activity.
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