Efficacy and Safety of Avanafil in the Patients With Erectile Dysfunction

Erectile Dysfunction Clinical Trial

Official title: A Randomized, Placebo Controlled, Double Blind, Multicenter Therapeutic Exploratory Clinical Study for the Evaluation of the Efficacy and Safety of Avanafil in the Patients With Erectile Dysfunction

Status Completed

Clinical Trial Summary

This is an exploratory clinical study to presume the optimum usage and dosage for a therapeutic confirmatory study by evaluating the efficacy and safety of Avanafil 50mg, 100mg, 200mg or placebo administered orally in patients with erectile dysfunction. In conclusions, Patients with erectile dysfunction (ED) were administered placebo, Avanafil 50mg, 100mg or 200mg 30 minutes before sexual intercourse for 8 weeks.

Clinical Trial Description

1. Study design: Prospective, randomized, double blind, placebo-controlled, therapeutic exploratory clinical study Usage & period One capsule was administered 30minutes before sexual intercourse.It was administered only once a day.

[Evaluation endpoints]

1. Safety: ① Laboratory tests: Hematological Test, Blood chemical Test, Urinalysis Vital signs: blood pressure, pulse rate ③ Adverse events and Adverse drug reaction ④12-lead ECG

2. Efficacy

• Primary endpoint ▪ The change of erectile function (EF) domain score in the international index of erectile function (IIEF)

• Secondary endpoint ▪ The change of success rate in sexual encounter profile (SEP) questionnaire 2, questionnaire 3, questionnaire 4 and questionnaire 5 ▪ The change of score in IIEF questionnaire 3 and questionnaire 4, The change of score in other domains of IIEF, GEAQ (Global efficacy assessment question), Normal erectile function (IIEF EF domain score ≥ 26) rate Statistical methods

1. Definition of Evaluation population Maximum efficacy evaluation population included the subjects who satisfied inclusion criteria, who took the investigational product at least once, who visited the hospital after taking the investigational product, and who got the result of efficacy evaluation. Safety-Evaluation Population consisted of the subjects who made a visit after taking the investigational product once or more and who got follow-up safety results

2. Initial Comparability Discrete variables were comparatively analyzed by χ2-test, Fisher's exact test, and Successive variables were comparatively analyzed by ANOVA test or Kruskal-Wallis test.

3. Efficacy Evaluation The change of EF domain score in the IIEF: Analysis of covariance(ANCOVA), in which baseline was corrected, was performed to check whether there was a difference between the placebo group and the Avanafil groups in change of EF domain score.

The change of score in other domains of IIEF: Analysis of covariance(ANCOVA), in which baseline was corrected, was performed to check whether there was a difference between the placebo group and the Avanafil groups.

The change of score in IIEF questionnaire 3 and questionnaire 4: Analysis of covariance(ANCOVA), in which baseline was corrected, was performed to check whether there was a difference between the placebo group and the Avanafil groups in IIEF questionnaire 3, questionnaire 4 respectively.

The change of success rate in SEP questionnaire 2, questionnaire 3, questionnaire 4 and questionnaire 5: Analysis of covariance(ANCOVA), in which baseline was corrected, was performed to check whether there was a difference between the placebo group and the Avanafil groups.

GEAQ (Global Efficacy Assessment Question) : The difference of GEAQ between groups was analyzed by χ2-test.

Normal erectile function(IIEF EF domain score ≥ 26) rate: The difference of Normal erectile function rate between groups was analyzed by χ2-test.

The efficacy results were analyzed by Dunnett's or Bonferroni's multiple comparison test to check whether there was a significant difference between the placebo group and the Avanafil groups.

4. Safety Evaluation Adverse Events and Adverse Drug Reaction: The difference between the placebo group and the Avanafil groups was compared by using χ2-test or Fisher's exact test. Adverse events reported in study subjects were presented by WHOART (World Health Organization Adverse Reaction Terminology) system organ class. The adverse drug reactions, related with the investigational product, were comparatively verified on the same method.

All statistical analyses were performed under significance level 5%, test power 80% and two-side test. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Erectile Dysfunction

• NCT number: NCT02477436
• Study type: Interventional
• Source: Pusan National University Hospital
• Status: Completed
• Phase: Phase 2
• Start date: February 2008
• Completion date: September 2008