A Phase II, Repeat Single Oral Dose Study of IPED2015 in Healthy Male Subjects With Erectile Dysfunction
Status:
Not yet recruiting
Trial end date:
2022-11-30
Target enrollment:
Participant gender:
Summary
This is a Phase II, randomised, double-blind, parallel-group, placebo-controlled study to
investigate the effects of repeat single oral doses of IPED2015 in otherwise healthy male
subjects with ED.
Up to 120 subjects are planned to be enrolled into 3 groups. Group 1 is planned to consist of
60 subjects, Group 2 is planned to consist of 36 subjects and Group 3 is planned to consist
of 24 subjects. Groups 1, 2 and 3 will be conducted in parallel. Each subject will be dosed
on four occasions. There will be three study treatments of dose 1 of IPED2015, dose 2 of
IPED2015 or matched placebo. In each group, subjects will be randomised evenly to each of the
three study treatments and will receive the same treatment on each visit.