STUDY 16: Non-Diabetic Men with ED
The 726 participants in this group were in stable monogamous heterosexual relationships, had a mild to severe history of ED for at least 6 months, and discontinued all ED medication, devices, and herbal treatments.
These patients were followed for 3 months. Formal results of the trial follows - skip down to the chart for a quick summary of the results...
The primary efficacy endpoint for both trials was the change in the Erectile Function domain of the International Index of Erectile Function (IIEF-ED) from baseline to the end of the three-month treatment period.
These patients were followed for 3 months and four of the five doses evaluated (7.5, 10, 12.5 and 15 mg) had clinically and statistically significant effects compared to the placebo.
....STUDY 17 - Men with ED and Diabetes Mellitus
294 diabetic ED patients were randomized to receive placebo or bremelanotide doses of 10 mg, 12.5 mg or 15 mg doses - similar to the men in Study 16.
In the Per Protocol Population the 12.5 mg and 15 mg doses had a change of 5.9 and 7.1, respectively in the IIEF-ED - placebo change was 2.3.
Although none of the doses evaluated were statistically significantly different from placebo in regards to penetration or ejaculation, all three doses were statistically significantly different than placebo for the GAQ - ie. patient satisfaction with bremelanotide relative to placebo.