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CHANGES IN METABOLIC PARAMETERS AND BONE MARKERS WITH ORAL VERSUS TOPICAL TESTOSTERONE (2022)
Fiona Yuen, Ronald S Swerdloff, Robert Dudley, and Christina Wang The Lundquist Institute at Harbor-UCLA Medical Center, Torrance, CA; Clarus Therapeutics, Northbrook, IL
Background: Oral testosterone undecanoate (TU) was recently evaluated for safety and efficacy in an open-label study in comparison with topical testosterone (T).
Methods: Hypogonadal men 18-65 yrs were randomized to oral TU or topical T for approximately 4 months. The starting dose was 237 mg TU twice daily and 60 mg topical T daily. Doses were titrated on Days 21 and 56. P1NP, CTX, and fasting insulin levels from baseline and the last visit (mean 142 days) were analyzed using stored samples in a subset of participants without diabetes. Hematocrit, systolic blood pressure (average of 3 measurements), HDL-C, LDL-C, and fasting glucose were previously assayed and the data are now assessed for changes from baseline and differences between the two drugs using linear mixed model analyses. Outliers (>3 IQR from 25th or 75th percentile) were excluded from the analyses.
Results: 203 of 222 participants completed the study (154 oral, 49 topical). Total T increased in both groups with treatment (oral, baseline 207 to 489 ng/dL; topical, baseline 204 to 383 ng/dL). SBP (oral, 2.61 ± 11.86; topical, 1.88 ± 9.81 mmHg) and hematocrit increased (oral, 6.0 ± 7.5%; topical, 4.6 ± 6.4%). HDL-C (oral, - 14.2 ± 15.5%; topical, -2.4 ± 16.2%) and total cholesterol decreased (oral, -4.3 ± 16.5%; topical, -4.6 ± 12.0%) (all p<0.001). HDL-C decreased to a greater extent with oral TU (p<0.001). LDL-C increased with oral TU but decreased with topical T (oral, 6.3 ± 26.5%; topical, -1.5 ± 18.0%; p = 0.014); this result was not significant after Bonferroni correction. There were no significant changes in triglycerides, glucose, insulin, P1NP, and CTX.
Conclusion: Both formulations decreased HDL-C and total cholesterol and increased SBP and hematocrit. HDL-C decreased to a greater extent with oral TU. Metabolic changes should be assessed for longer durations in larger studies.
Fiona Yuen, Ronald S Swerdloff, Robert Dudley, and Christina Wang The Lundquist Institute at Harbor-UCLA Medical Center, Torrance, CA; Clarus Therapeutics, Northbrook, IL
Background: Oral testosterone undecanoate (TU) was recently evaluated for safety and efficacy in an open-label study in comparison with topical testosterone (T).
Methods: Hypogonadal men 18-65 yrs were randomized to oral TU or topical T for approximately 4 months. The starting dose was 237 mg TU twice daily and 60 mg topical T daily. Doses were titrated on Days 21 and 56. P1NP, CTX, and fasting insulin levels from baseline and the last visit (mean 142 days) were analyzed using stored samples in a subset of participants without diabetes. Hematocrit, systolic blood pressure (average of 3 measurements), HDL-C, LDL-C, and fasting glucose were previously assayed and the data are now assessed for changes from baseline and differences between the two drugs using linear mixed model analyses. Outliers (>3 IQR from 25th or 75th percentile) were excluded from the analyses.
Results: 203 of 222 participants completed the study (154 oral, 49 topical). Total T increased in both groups with treatment (oral, baseline 207 to 489 ng/dL; topical, baseline 204 to 383 ng/dL). SBP (oral, 2.61 ± 11.86; topical, 1.88 ± 9.81 mmHg) and hematocrit increased (oral, 6.0 ± 7.5%; topical, 4.6 ± 6.4%). HDL-C (oral, - 14.2 ± 15.5%; topical, -2.4 ± 16.2%) and total cholesterol decreased (oral, -4.3 ± 16.5%; topical, -4.6 ± 12.0%) (all p<0.001). HDL-C decreased to a greater extent with oral TU (p<0.001). LDL-C increased with oral TU but decreased with topical T (oral, 6.3 ± 26.5%; topical, -1.5 ± 18.0%; p = 0.014); this result was not significant after Bonferroni correction. There were no significant changes in triglycerides, glucose, insulin, P1NP, and CTX.
Conclusion: Both formulations decreased HDL-C and total cholesterol and increased SBP and hematocrit. HDL-C decreased to a greater extent with oral TU. Metabolic changes should be assessed for longer durations in larger studies.
