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Efficacy and Safety of Avanafil in the Patients With Erectile Dysfunction

NCT02477436 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 159

Last updated 2015-06-24

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Avanafil

* One capsule should be taken with water, 30 minutes before sexual intercourse. It should be taken only once a day. * Intemperance in eating and drinking should not be done, 2 hours before and 2 hour after taking the investigational product. * Investigational products were administered prior to the sexual intercourse for total 8 weeks.

DRUG

Placebo

* One capsule should be taken with water, 30 minutes before sexual intercourse. It should be taken only once a day. * Intemperance in eating and drinking should not be done, 2 hours before and 2 hour after taking the placebo. * Placebos were administered prior to the sexual intercourse for total 8 weeks.

Sponsors & Collaborators

  • Pusan National University Hospital

    lead OTHER

Principal Investigators

  • Hyun Jun Park, PhD, MD · Department of Urology, Pusan National University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
70 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2008-09-30
Completion
2008-09-30

Countries

  • South Korea

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02477436 on ClinicalTrials.gov