This Study is to Evaluate the Safety and Efficacy of Avanafil in the Treatment of Erectile Dysfunction.

NCT01705197 | Completed Phase 3

• 2 other identifiers: JW-AVA-302임상제도과-2221
• Study Type: interventional
• Target: 195
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to evaluate the safety and efficacy of Avanafil in the treatment of erectile dysfunction with moderate to severe in subjects. And, this is to additionally confirm the efficacy and safety after initiating treatment with Avanafil 100mg and later increasing to 200mg, compared with continuing treatment with Avanafile 100mg, in subjects.

Conditions

Erectile Dysfunction

Outcome Measures

Primary Outcomes (1)

• Compare with the changes in IIEF(The International Index of Erectile Function)Erectile Function domain score between the study group and control group.

  When changes in IIEF EF domain score of the study group (Avanafil-administered group) and control group (placebo-administered group) are compared to the baseline after 12 weeks post medication, it is to evaluate the superiority of the study group.

  12 weeks

Secondary Outcomes (1)

• Compare with the MSHQ, SEP Q2, SEP Q3 and GEAQ.

  12 weeks

Other Outcomes (1)

• We will be confirming the safety after initiating treatment with Avanafil 100mg and later increasing to 200mg, compared with continuing treatment with Avanafil 100mg.

  12weeks

Study Arms (2)

Avanfil 100 or 200mg

ACTIVE COMPARATOR

All subjects, who are judged to be suitable to the clinical trial after 4-week free run-in period was completed, should be administered with Avanafil 100mg(study group) or placebo 100mg(control group) for the first 4 weeks after randomization. When there are no moderate to severe adverse events at the 4 weeks evaluation after administration, and when it is decided by the researcher that the effect of Avanafil or placebo 100mg against erectile dysfunction is insufficient, a dosage increase to 200mg is executed. For subjects with a sufficient improvement effect on ED at 100mg, no dosage increase is allowed, and the previous 100mg administration should be maintained until the termination of the study.

Drug: Avanafil 100 or 200mg

Placebo 100mg or 200mg

PLACEBO COMPARATOR

When there are no moderate to severe adverse events at the 4 weeks evaluation after administration, and when it is decided by the researcher that the effect of Avanafil or placebo 100mg against erectile dysfunction is insufficient, a dosage increase to 200mg is executed.

Drug: Avanafil 100 or 200mg

Interventions

Avanafil 100 or 200mg DRUG

This study is designed as a double-blind, stratified randomized, placebo controlled, parallel group, multicenter, dose escalation study. For subjects with moderate to severe ED who have voluntarily signed the consent form, conduct screening and undertake the 4 weeks Free run-in period. For those who satisfy the study criteria during the review of subject's diaries composed during the free run-in period and the evaluation of inclusion/exclusion criteria at a future visit, drugs for each group are provided after randomized to Avanafil 100mg or placebo 100mg at a ratio of 2:1. At this time, subjects are random stratified to each group depending on their diabetes status.

Also known as: Zepeed 100mg or 200mg

Avanfil 100 or 200mg; Placebo 100mg or 200mg

Eligibility Criteria

• Age: 20 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male patients over 20 years old with a history of erectile dysfunction for at least 6 months prior to participation in the study
• Patients in a stable relationship with 1 female partner
• Patients whose sex partner is not in pregnancy or lactating, and is taking proper contraceptive
• Patients who have voluntarily decided to participate in this clinical trial, and signed the informed consent form
• Patients whose failure rate for sexual intercourse is more than 50% after attempts of sexual intercourse on more than 3 different days (once/day) at least during the 4-week Free run-in period
• Patients whose EF domain score is less than 18 points (moderate to severe erectile dysfunction) in the IIEF questionnaire after the 4-week Free run-in period

You may not qualify if:

• Patients who have a spinal injury or have had a radical prostatectomy
• Patients with anatomical malformations of the penis (example: angulation, fibrosis of corpus cavernosum, peyronies disease, etc.)
• Patients who had surgery in the pelvic cavity within 6 months prior to participation in the study
• Patients with neurogenic or endocrine (example: hyperprolactinemia, low testosterone, etc.) ED
• Hyperprolactinemia: Serum prolactin ≥ 3 X ULN
• Low testosterone: Total testosterone is less than the normal lower limit(testosterone is susceptible to daily changes, so enrollment is permitted after retesting before 11 am, only limited to once, when the number is 20% less than the normal lower limit.)
• Patients with a major refractory psychiatric disorder (including major depression or schizophrenia) or significant neurological abnormalities (neurovascular disease)
• Patients with alcohol addiction or persistent abuse of drugs of dependence
• Patients with hepatic dysfunction or renal dysfunction as per the following:
• Hepatic dysfunction: AST, ALT ≥ 3 X ULN
• Renal dysfunction: Serum creatinine \> 2.0mg/dL
• Diabetic patients whose HbA1c exceeds 12%
• Patients with proliferative diabetic retinopathy
• Patients who have had a stroke, TIA(Transient ischemic attack), MI(Myocardial Infarction) or fatal arrhythmia, or severe heart failure, unstable angina or who underwent coronary artery bypass grafting (CABG) within the last 6 months prior to participation in the study
• Patients with hypotension (resting SBP/DBP in the sitting position is less than 90/50mmHg) or unregulated hypertension (resting SBP/DBP in the sitting position exceeds 170/100mmHg)

Sponsors & Collaborators

• JW Pharmaceutical: lead

Study Sites (1)

Catholic Univ. Seoul St. Mary's Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Erectile Dysfunction

Condition Hierarchy (Ancestors)

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

Study Officials

• Kim Se Woong, Doctor

  Catholic hospital in Korea

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2012
• First Posted: October 12, 2012
• Study Start: February 1, 2012
• Primary Completion: April 1, 2013
• Study Completion: November 1, 2013
• Last Updated: March 10, 2017

Record last verified: 2017-03

Locations

KR (1)