METHODS: This double-blind, multicenter, phase 3 study consisted of a 1-week observation period during which patients were treated with two patches of placebo, followed by a 6-week double-blind period where patients were randomized (1:1:1) to receive once-daily blonanserin 40 mg, blonanserin 80 mg, or placebo patches. The primary endpoint was the change from baseline in the total Positive and Negative Symptom Scale (PANSS) score. Safety assessments included treatment-emergent adverse events (TEAEs).
RESULTS: Between December 2014 and October 2018, patients were recruited and randomly assigned to blonanserin 40 mg (n = 196), blonanserin 80 mg (n = 194), or placebo (n = 190); of these, 77.2% completed the study. Compared with placebo, blonanserin significantly improved PANSS total scores at 6 weeks (least square mean [LSM] difference vs placebo: -5.6 with blonanserin 40 mg; 95% confidence interval [CI] -9.6, -1.6; adjusted p = 0.007, and - 10.4 with blonanserin 80 mg; 95% CI -14.4, -6.4; adjusted p
METHODS: Focus group interviews were conducted to determine the construct of the questionnaire. Content and face validity were assessed by a panel of experts. A pilot study was conducted to validate the Sexual Dysfunction in Asian Men with Diabetes (SAD-MEN) questionnaire in English and Malay. The International Index of Erectile Function-5 (IIEF-5) was used for comparison. Construct validity was assessed using exploratory factor analysis, reliability was determined using Cronbach's α (> 0.700), and test-retest reliability using Spearman's rank correlation coefficient.
RESULTS: The SAD-MEN questionnaire yielded moderate face and content validity, with high reliability as shown by Cronbach's α values of 0.949 for sexual performance and 0.775 for sexual desire for the English version. The Malay language questionnaire had a Cronbach's α value of 0.945 for sexual performance and 0.750 for sexual desire. Test-retest reliability using Spearman's test gave correlation coefficients of r = 0.853, P = 0.000 for the English language questionnaire and r = 0.908, P = 0.000 for the Malay language questionnaire.
CONCLUSION: The SAD-MEN questionnaire is a valid and reliable tool by which to assess sexual dysfunction in English- and Malay-speaking Malaysian and South East Asian men with diabetes.