TRAVERSE Sexual Function Study

[madman]

Effect of Testosterone Replacement Therapy on Sexual Function and Hypogonadal Symptoms in Men with Hypogonadism

AbstractContext. Few long-term randomized trials have evaluated the efficacy of testosterone replacement therapy (TRT) in improving sexual function and hyp

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Within the larger TRAVERSE trial, the Sexual Function Study focuses on the impact of TRT on sexual activity, hypogonadal symptoms, libido, and erectile function in men with low libido.

The study involves 5204 men aged 45 to 80 with low testosterone, hypogonadal symptoms, and cardiovascular risk. Among these, 1161 men with low libido were included in the Sexual Function Study, with half receiving 1.62% testosterone gel and the others a placebo gel. The primary outcome measured is the change in sexual activity score, and secondary outcomes include hypogonadal symptoms, erectile function, and sexual desire.

Results show that TRT leads to a significantly greater improvement in sexual activity compared to placebo at 6 and 12 months, with the effect maintained at 24 months. TRT also improves hypogonadal symptoms and sexual desire, but there is no substantial effect on erectile function.

In conclusion, the study demonstrates that TRT over two years improves sexual activity, hypogonadal symptoms, and sexual desire in middle-aged and older men with hypogonadism and low libido, while not significantly affecting erectile function.

 

[madman]

 

[madman]

Table 1 Baseline Characteristics of Participants in the TRAVERSE Sexual Function Trial and in the Full Analysis Set

Legend. The data are mean (standard deviation, SD) unless otherwise specified. If the total number of available records was different than total population set, the actual sample size is presented in the brackets. To convert serum total testosterone concentrations in nanograms per deciliter to nanomoles per liter, multiply testosterone concentration in nanograms per deciliter by 0.0347. To convert estradiol concentrations 2 from picogram per milliliter to picomoles per liter, multiply estradiol concentrations in 3 picogram per milliliter by 3.67. To convert dihydrotestosterone concentrations in 4 nanograms per deciliter to nanomoles per liter, multiply dihydrotestosterone 5 concentrations in nanograms per deciliter by 0.0344.

 

[madman]

Table 2. Post-randomization Testosterone, DHT and Estradiol

Legend. Means and standard deviations (SD) are presented for baseline and each visit for subjects with a measurement at the visit. Least Square Means (LS Means) estimates of change from baseline (95% confidence interval (CI)) for each group and the difference between TRT and placebo at each visit are derived from a linear mixed effects model controlling for baseline value and pre-existing CVD, assuming an unstructured covariance matrix. The omnibus test p value (P) is a test of the null hypothesis of no difference between TRT and placebo groups across all time points. To convert serum total testosterone concentrations in nanograms per deciliter to nanomoles per liter, multiply testosterone concentration in nanograms per deciliter by 0.0347. To convert estradiol concentrations from picogram per milliliter to picomoles per liter, multiply estradiol concentrations in picogram per milliliter by 3.67. To convert
dihydrotestosterone concentrations in nanograms per deciliter to nanomoles per liter, multiply dihydrotestosterone concentrations in nanograms per deciliter by 0.0344.

Yr, years; CVD, cardiovascular disease; PDQ-4, question 4 of the Psychosexual Diary Questionnaire; HIS-Q, Hypogonadism Impact of Symptoms Questionnaire; PDE5 Inhibitor, Selective phosphodiesterase 5 inhibitor

 

[madman]

Figure 1. Model-estimated changes from baseline in overall sexual activity (PDQ-4 score) in participants enrolled in the Sexual Function Study.

Legend: A linear mixed model was fit with fixed effects for treatment, visit, and treatment-visit interaction, baseline PDQ-4 score and pre-existing cardiovascular disease and a random per-subject repeated measures effect with an unstructured covariance matrix. The mean and the corresponding 95% confidence intervals are shown by treatment group and time point. The omnibus test p value from a test of the null hypothesis of no difference between the TRT and placebo groups across all time points is shown

 

[madman]

Figure 2. Model-estimated changes from baseline in hypogonadal symptoms (Composite HIS-Q score) (Panel A, top), sexual symptoms (Sexual symptom domain of HIS-Q) (Panel B, middle) and sexual desire (HIS-Q libido subdomain score) (Panel C, bottom) in men enrolled in the Sexual Function Study.

Legend: A linear mixed model was fit to each of the three scores, separately, with fixed effects for treatment, visit, and treatment-visit interaction, corresponding baseline score and pre-existing cardiovascular disease and a random per-subject repeated measures effect with an unstructured covariance matrix. The mean and the corresponding 95% confidence intervals are shown by treatment group and time point. The omnibus test p values were derived separately for each score and were derived from a test of the null hypothesis of no difference between the TRT and placebo groups across all time points.

 

[madman]

Figure 3. Model-based estimates of Patient Global Impression of Change - Libido score 3 at each visit.

Legend: A linear mixed model was fit with fixed effects for treatment, visit, and treatment-visit interaction and pre-existing cardiovascular disease and a random per subject repeated measures effect with an unstructured covariance matrix. Lower scores on HIS-Q indicate improvement (fewer symptoms). The mean and the corresponding 95% confidence intervals are shown by treatment group and time point. The omnibus test p value from a test of the null hypothesis of no difference between the TRT and placebo groups across all time points is shown.

 

[madman]

Figure 4. Model-estimated change from baseline in erectile function, assessed using 13 IIEF-5, in men enrolled in the Sexual Function Study.

Legend: A linear mixed model was fit with fixed effects for treatment, visit, and treatment-visit interaction, baseline value, pre-existing cardiovascular disease and a random per-subject repeated measures effect with an unstructured covariance matrix. The mean and the corresponding 95% confidence intervals are shown by treatment group and time point. The omnibus test p value from a test of the null hypothesis of no difference between the TRT and placebo groups across all time points is shown.

 

[madman]

Figure 5. Model-based estimates of change in HIS-Q and its Sexual function and Libido 2 subdomain scores in all TRAVERSE participants (Panels A, B, and C respectively).

Legend: A linear mixed model was fit to each of the three scores, separately, with fixed effects for treatment, visit, and treatment-visit interaction, corresponding baseline value and pre-existing cardiovascular disease and a random per-subject repeated measures effect with an unstructured covariance matrix. Lower scores on HIS-Q indicate improvement (fewer symptoms). The mean and the corresponding 95% confidence intervals are shown by treatment group and time point. The omnibus test p values were derived separately for each score and were derived from a test of the null hypothesis of no difference between the TRT and placebo groups across all time points.

 

[madman]

Figure 6. Preplanned subgroup analyses of the PDQ-4 by CVD risk (Panels A and B), age group (65 years or older, < 65 years, Panels C and D), baseline testosterone level (< 250 ng/dl; 250 ng/dl or higher; Panel E and F) and race (Black, White; Panels G and H).

Legend. Four separate linear mixed models were fit with fixed effects for treatment, visit, subpopulation variable (prior CVD risk group, age, testosterone level or race), corresponding two- and three-way interaction terms, baseline PDQ-4 value and a random per-subject repeated measures effect with an unstructured covariance matrix. The models with age, testosterone level or race also included pre-existing cardiovascular disease as a covariate. The LS Means and the corresponding 95% confidence intervals are shown by treatment group and time point for each age group. The omnibus test p value from a test of the null hypothesis of no difference between the TRT and placebo groups across all time points for each age group is shown. The p value for the contrast test of interaction that tested if there is a difference in treatment effect between the two CVD risk groups was 0.421; age groups was 0.338, baseline testosterone levels was 0.089 and race was 0.822.

 

[Nelson Vergel]

@madman you always find stuff even before publication date. Thank you