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Therapeutic Confirmatory Study to Evaluate the Efficacy and Safety of Avanafil (ALERT)

Primary Purpose

Erectile Dysfunction

Status

Completed

Phase

Phase 3

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Avanafil

Placebo

About this trial

This is an interventional treatment trial for Erectile Dysfunction

Eligibility Criteria

19 Years - 70 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

male subjects aged 19 to 70 with history of erectile dysfunction for at least 6 months
subjects have stable monogamous relationships
their partners are free from pregnancy and lactation and well prevent conception
subjects consented to participate in the clinical study in writing
subjects attempted sexual intercourse at least 4 times in separate days during 4 weeks' free run-in period, and failure rate is over 50%

Exclusion Criteria:

history of spinal cord injury or radical prostatectomy
subjects whose penises are anatomically deformed
erectile dysfunction due to neurogenic or endocrine cause
subjects who have uncontrolled major psychiatric disorder and do not accept therapies or have significant neurological abnormalities
history of cancer chemotherapy within 1 year
subjects who are addicted to alcohol or have continuously misused dependent drugs
subjects who have hepatic dysfunction(GOP,GPT ≥ 3xUNL) or renal dysfunctions(serum creatinine > 2.0)
subjects who have uncontrollable diabetes(FPG>180)
subjects sho have proliferative diabetic retinopathy
history of stroke, transient ischemic attacks, myocardial infarction, heart failure that needs to be medically treated, unstable angina or fatal arrhythmia or coronary artery bypass graft within 6 months
serious hypotension or uncontrollable severe hypertension
hematological disorders that is likely to be developed into priapism such as sickle cell disease, multiple myeloma, leukemia
subjects who have retinitis pigmentosa
subjects who suffered from serious GI bleeding disorder within 1 year
subjects who took other PDE5 inhibitors or ED therapies within 2 weeks
subjects who use non-concomitant medications(Nitrate/NO donors, Androgens, anti-androgen, trazodone, Anticoagulant,over-the-counter drugs known to inhibit the activity of CYP3A4)
history of hypersensitivity to the PDE5 inhibitors or not responded to them
subjects who have hypoactive sexual desire
subjects who have no intention of having sexual intercourses 4 times in separate days during 4 weeks' free run-in period
subjects who took other investigational products within 30 days before this clinical study
subjects who are judged to be unsuitable to the clinical study by other reasons

Sites / Locations

Chonbuk national university hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Avanafil 100mg

Avanafil 200mg

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Change of EF domain score in the IIEF(The International Index of Erectile Function)

Secondary Outcome Measures

Change of successful rate in SEPQ2,Q3,Q4,Q5 Change of score in other domains of IIEF Change of IIEF Q3 and Q4 score GEAQ The rate of normal erectile function

Full Information

NCT ID

NCT00903981

First Posted

May 18, 2009

Last Updated

April 22, 2010

Sponsor

JW Pharmaceutical

1. Study Identification

Unique Protocol Identification Number

NCT00903981

Brief Title

Therapeutic Confirmatory Study to Evaluate the Efficacy and Safety of Avanafil

Acronym

ALERT

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2009

Overall Recruitment Status

Completed

Study Start Date

March 2009 (undefined)

Primary Completion Date

October 2009 (Actual)

Study Completion Date

November 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

JW Pharmaceutical

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to confirm the efficacy and the safety of Avanafil 100mg, 200mg or placebo administered orally for 12 weeks in patients with erectile dysfunction. The efficacy is evaluated by IIEF, SEP Q2 and Q3 and GEAQ and the safety is evaluated by laboratory tests, vital signs, physical examination and adverse events.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Erectile Dysfunction

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

208 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Avanafil 100mg

Arm Type

Experimental

Arm Title

Avanafil 200mg

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Avanafil

Intervention Description

2 tablets(Avanafil 100mg tablet + Placebo 200mg tablet), 30 minutes before sexual intercourse

Intervention Type

Drug

Intervention Name(s)

Avanafil

Intervention Description

2 Tablets(Avanafil 200mg tablet + Placebo 100mg tablet), 30 minutes before sexual intercourse

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

2 Tablets(Placebo 100mg tablet + Placebo 200mg tablet), 30 minutes before sexual intercourse

Primary Outcome Measure Information:

Title

Change of EF domain score in the IIEF(The International Index of Erectile Function)

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Change of successful rate in SEPQ2,Q3,Q4,Q5 Change of score in other domains of IIEF Change of IIEF Q3 and Q4 score GEAQ The rate of normal erectile function

Time Frame

12 weeks

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: male subjects aged 19 to 70 with history of erectile dysfunction for at least 6 months subjects have stable monogamous relationships their partners are free from pregnancy and lactation and well prevent conception subjects consented to participate in the clinical study in writing subjects attempted sexual intercourse at least 4 times in separate days during 4 weeks' free run-in period, and failure rate is over 50% Exclusion Criteria: history of spinal cord injury or radical prostatectomy subjects whose penises are anatomically deformed erectile dysfunction due to neurogenic or endocrine cause subjects who have uncontrolled major psychiatric disorder and do not accept therapies or have significant neurological abnormalities history of cancer chemotherapy within 1 year subjects who are addicted to alcohol or have continuously misused dependent drugs subjects who have hepatic dysfunction(GOP,GPT ≥ 3xUNL) or renal dysfunctions(serum creatinine > 2.0) subjects who have uncontrollable diabetes(FPG>180) subjects sho have proliferative diabetic retinopathy history of stroke, transient ischemic attacks, myocardial infarction, heart failure that needs to be medically treated, unstable angina or fatal arrhythmia or coronary artery bypass graft within 6 months serious hypotension or uncontrollable severe hypertension hematological disorders that is likely to be developed into priapism such as sickle cell disease, multiple myeloma, leukemia subjects who have retinitis pigmentosa subjects who suffered from serious GI bleeding disorder within 1 year subjects who took other PDE5 inhibitors or ED therapies within 2 weeks subjects who use non-concomitant medications(Nitrate/NO donors, Androgens, anti-androgen, trazodone, Anticoagulant,over-the-counter drugs known to inhibit the activity of CYP3A4) history of hypersensitivity to the PDE5 inhibitors or not responded to them subjects who have hypoactive sexual desire subjects who have no intention of having sexual intercourses 4 times in separate days during 4 weeks' free run-in period subjects who took other investigational products within 30 days before this clinical study subjects who are judged to be unsuitable to the clinical study by other reasons

Overall Study Officials: