JOURNAL ARTICLE
MULTICENTER STUDY
RANDOMIZED CONTROLLED TRIAL

Efficacy of udenafil for the treatment of erectile dysfunction up to 12 hours after dosing: a randomized placebo-controlled trial

Hyun Jun Park, Jong Kwan Park, Kwangsung Park, Kweonsik Min, Nam Cheol Park
Journal of Sexual Medicine 2010, 7 (6): 2209-2216
20412426

INTRODUCTION: Udenafil is a newly developed selective phosphodiesterase type 5 inhibitor for the treatment of men with erectile dysfunction (ED).

AIM: To evaluate the efficacy of udenafil in treating ED for up to 12 hours after dosing.

METHODS: This was a randomized, double-blind, placebo-controlled, parallel-group, fixed dose design, multicenter study. Following a 4-week nondrug baseline period, 104 men with ED of broad etiology and severity were randomized to one of two treatment groups: udenafil 100 mg or placebo. Participants were requested to attempt sexual intercourse at 12 hours after udenafil or placebo dosing during a 4-week treatment period.

MAIN OUTCOME MEASURES: The primary efficacy variable was the response of patients to question 3 of the Sexual Encounter Profile (SEP Q3). The secondary efficacy measures were the response of patients to question 2 of the Sexual Encounter Profile (SEP Q2). Additional secondary efficacy measures included changes from baseline in the erectile function (EF) domain scores of the International Index of Erectile Function (IIEF) questionnaire.

RESULTS: Of the 104 patients, 103 (50 in the udenafil group, 53 in the placebo group) completed the study. Udenafil significantly enhanced the rate of maintenance of erection (SEP Q3; placebo, 28.3% vs. udenafil, 54.7%; P < 0.0001). Significant change from baseline in the IIEF-EF domain was observed in the udenafil group (placebo, -0.58 ± 0.67; udenafil, 4.40 ± 0.84; P < 0.0001). For SEP Q2, there was no difference from baseline and no difference between the two groups. The overall adverse events rate was 11.3%. Most adverse events were mild or moderate in severity, and no serious adverse events were reported during the study and the follow-up period.

CONCLUSIONS: Udenafil at 100 mg was effective for relieving ED for up to 12 hours after dosing. This duration of effectiveness could allow for flexibility and spontaneity in the sexual lives of patients.

Full Text Links

Find Full Text Links for this Article

Discussion

You are not logged in. Sign Up or Log In to join the discussion.

Related Papers

Remove bar
Read by QxMD icon Read
20412426
×

Save your favorite articles in one place with a free QxMD account.

×

Search Tips

Use Boolean operators: AND/OR

diabetic AND foot
diabetes OR diabetic

Exclude a word using the 'minus' sign

Virchow -triad

Use Parentheses

water AND (cup OR glass)

Add an asterisk (*) at end of a word to include word stems

Neuro* will search for Neurology, Neuroscientist, Neurological, and so on

Use quotes to search for an exact phrase

"primary prevention of cancer"
(heart or cardiac or cardio*) AND arrest -"American Heart Association"