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Property:Results during intervention

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4 month after therapy start: Significant increase in positive tests in the Carnitin + Sildenafil Arm compared to Baseline (36.4% vs. 63.6%; p < 0.01)  +
Carnitin + Sildenafil Arm and Sildenafil + Placebo Arm had significantly more side effects than the Placebo Arm (χ² = 18.786; p < 0.01), but no difference between the intervention arms  +
4 month after therapy start: Higher satisfaction in the Carnitin-Sildenafil Arm (87.5%) compared to the Sildenafil + Placebo Arm (51.3%; p < 0.05) and in the Sildenafil + Placebo Arm compared to the Placebo Arm (6.8%; p < 0.01)  +
4 month after therapy start: Carnitin + Sildenafil Arm significantly better than Sildenafil + Placebo Arm, and Sildenafil + Placebo Arm better than Placebo Arm in domains: Erectile Function (Mean(SD) = 27.3 (4.6) > 21.7 (6.8) > 11.7 (3.7)), Satisfaction with Sexual Activity (8.9 (4.7) > 4.8 (2.5) > 3.1 (0.6)), Orgasm (8.8 (2.6) > 5.9 (2.9) > 3.0 (0.6)), and General Sexual Well-Being (8.6 (2.0) > 5.4 (2.7) > 2.8 (0.7); p = not given)  +
Per arm: * Poly E 600 arm: 27% grade II weight gain (day 138 on study drug), grade III indigestion (day 40), grade III insomnia (day 6) * Poly E 400 arm: 6.25% grade III rectal bleeding (day 18) * Poly E 800 arm: 33% grade III alanine aminotransferase (ALT) elevation (day 91) Rectal bleeding occurred in a woman with pre-existing diverticulosis and required hospitalization; after this serious adverse event, the protocol was amended to exclude women with a prior history of a gastrointestinal bleed.  +
After 2 weeks (end of phase I, ITT-Analysis and PP-Analysis): No differences between arms and/or time points  +
After 2 weeks (end of phase I, ITT-Analysis and PP-Analysis): No differences between arms and/or time points  +
After 2 weeks (end of phase I, ITT-Analysis and PP-Analysis): No differences between arms and/or time points  +
After 2 weeks (end of phase I, ITT-Analysis and PP-Analysis): No differences between arms and/or time points  +