Efficacy and Safety of Avanafil in the Patients With Erectile Dysfunction

NCT02477436 | Completed Phase 2 DMC

• 1 other identifier: Avanafil-Korea
• Study Type: interventional
• Target: 159
• Locations: 1 country
• Sites: 1

Brief 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

Erectile Dysfunction

Outcome Measures

Primary Outcomes (1)

• Change of erectile (EF) domain score in the international index of erectile function (IIEF) questionnaire

  Week 4 and 8

Secondary Outcomes (5)

• The change of success rate for SEP (Sexual encounter profile) questionnaire 2,3,4 and 5

  Week 4 and 8

• The change of score in orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction domains in international index of erectile function (IIEF)

  Week 4 and 8

• The change of score in the international index of erectile function (IIEF) questionnaire 3 and 4

  Week 4 and 8

• Improvement of erection on the GEAQ (Global Efficacy Assessment Question) questionnaire

  Week 4 and 8

• Normal erectile function (IIEF EF domain score ≥ 26) rate

  Week 4 and 8

Study Arms (4)

Avanafil 50mg group

EXPERIMENTAL

Avanafil 50mg tablet + Placebo 100mg tablet

Drug: Avanafil

Avanafil 100mg group

EXPERIMENTAL

Avanafil 100mg tablet + Placebo 100mg tablet

Drug: Avanafil

Avanafil 200mg group

EXPERIMENTAL

Avanafil 100mg 2 tablets

Drug: Avanafil

Placebo group

PLACEBO COMPARATOR

Placebo 100mg 2tablets

Drug: Placebo

Interventions

Avanafil DRUG

* 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.

Also known as: Phosphodiesterase 5 inhibitor

Avanafil 100mg group; Avanafil 200mg group; Avanafil 50mg group

Placebo DRUG

* 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.

Placebo group

Eligibility Criteria

• Age: 19 Years - 70 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The male subjects who were aged 19 \~ 70 with history of erectile dysfunction for at least 6 months duration
• The subjects who had had stable monogamous relationships with their female partners
• Their partners were free from pregnancy and lactation and well prevent conception
• The subjects who were judged to be suitable to the clinical study in consequence of screening test
• The subjects who consented to participate in the clinical study in writing
• The subjects who attempted sexual intercourses at least 4 times in separate days during 4 weeks' free run-in period, and whose failure rate was over 50%.
• The subjects whose point were between 11 and 25 in EF domain of IIEF after 4 weeks' free run-in period

You may not qualify if:

• The following cases were excluded from this clinical study.
• The subjects who had spinal cord injury or who underwent radical prostatectomy
• The subjects whose penises were anatomically deformed (Ex: server penile fibrosis, and Peyronie's disease)
• The subjects who had erectile dysfunction due to neurogenic or endocrine cause (hyperprolactinemia, low serum testosterone levels, etc.)
• Hyperprolactinemia: serum prolactin over 3 times higher than the upper limit
• Low Testosterone: serum total testosterone less than the lower limit
• The subjects who had uncontrolled major psychiatric disorder and did not accept therapies (includes major depressions and schizophrenia) or had significant neurological abnormalities (neurovascular disorder)
• The subjects who underwent cancer chemotherapy within 1 year
• The subjects who were addicted to alcohol or who had continuously misused dependent drugs
• The subjects who had hepatic dysfunction or renal dysfunction as in the following:
• Hepatic Dysfunction: GOT and GPT (glutamate-pyruvate transaminase) were three times higher than the upper limit
• Renal Dysfunction: serum creatinine was over 2.0mg/dl
• The subjects who had uncontrollable diabetes (FPG\>180mg/dL)
• The subjects who had proliferative diabetic retinopathy
• The subjects who suffered from stroke, transient ischemic attacks, myocardial infarction, heart failure that needed to be medically treated, unstable angina or fatal arrhythmia or who underwent coronary artery bypass graft within 6 months

Sponsors & Collaborators

• Pusan National University Hospital: lead

Study Sites (1)

Department of Urology, Pusan National University Hospital

Busan, 602-739, South Korea

Location

Related Publications (1)

• Park HJ, Kim SW, Kim JJ, Lee SW, Paick JS, Ahn TY, Park K, Park JK, Park NC. A Randomized, Placebo-Controlled, Double-Blind, Multi-Center Therapeutic Confirmatory Study to Evaluate the Safety and Efficacy of Avanafil in Korean Patients with Erectile Dysfunction. J Korean Med Sci. 2017 Jun;32(6):1016-1023. doi: 10.3346/jkms.2017.32.6.1016.

  PMID: 28480661 DERIVED

MeSH Terms

Conditions

Erectile Dysfunction

Interventions

avanafil; Phosphodiesterase 5 Inhibitors

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Phosphodiesterase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Hyun Jun Park, PhD, MD

  Department of Urology, Pusan National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2015
• First Posted: June 22, 2015
• Study Start: February 1, 2008
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: June 24, 2015

Record last verified: 2015-06

Locations

KR (1)