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Qualitative Synthesis. Melanotan II versus placebo






Melanotan II versus placebo. One small trial enrolling 20 subjects, 10 men with psychogenic ED and 10 men with organic ED, compared the efficacy and harms of Melanotan II (SC) to placebo 295. Melanotan II was administered by the investigator in doses between 0.025 mg/kg and 0.157 mg/kg in a double blind, placebo-controlled fashion. Subjects were monitored by RigiScan in the clinic and at home for a total of 6 hours.

Harms. Men administered Melanotan II reported an increased frequency of nausea (38.5 percent versus 9.8 percent), yawning and stretching (56.4 percent versus 12.2 percent). 295

Efficacy. 17 of the 20 subjects administered Melanotan II reported a “subjectively apparent erection” on at least one of two injections of Melanotan II. The number of subjects with improved erections following administration of placebo was not reported. Overall, erectile activity (based on RigiScan activity) was reported in 69 percent (27/39) of Melanotan II injections compared with 2 percent (1/41) of placebo injections. In a subgroup analysis of the 10 subjects with organic ED, nine men treated with Melanotan II reported a “subjectively apparent erection” versus one placebo treated subject 296. Erectile activity was reported in 63 percent (12/19) of Melanotan II injections compared with 2 percent (1/21) of placebo injections.

PT-141 versus placebo. One small trial that enrolled 25 subjects with moderate to severe ED who had an inadequate response tosildenafil compared the efficacy and harms of PT-141 (SC) to placebo298. PT-141 was administered in doses of 4 or 6 mg, utilizing a placebo-controlled three-way crossover design298. Patients were kept under observation until 24 hours after the dose administration.

Harms. Men who were administered PT-141 reported an increased frequency of nausea (4 mg: 24 percent versus 6 mg: 36 percent versus placebo: 0 percent) and headache (4 mg: 36 percent versus 6 mg: 27 percent versus placebo: 0 percent) compared with placebo.

Efficacy. Clinically and statistically significant erectile response (assessed by RigiScan) in the presence of visual sexual stimulation was observed following the administration of single dose of 4 or 6 mg PT-141, relative to placebo. A greater than two-fold increase in the duration of base rigidity ≥ 60 percent, compared with placebo, was reported in 82 percent of subjects receiving the 4 mg dose and 84 percent of patients receiving the 6 mg dose.

Apomorphine versus placebo. One small trial enrolling 12 subjects with coital erectile failure of at least 6 months compared apomorphine (SC) to placebo.297

Harms. Eight subjects reported side effects, including yawning, drowsiness and nausea. Two participants experienced extreme nausea and hypotension, with one transiently losing consciousness after the 1.0 mg apomorphine dose.

Efficacy. Eleven out of the 12 subjects exceeded a change of 1cm in circumference after injection).


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