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

NCT ID: NCT01705197

Last Updated: 2017-03-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 195 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2013-11-30

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.

Detailed Description

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.

Conditions

Erectile Dysfunction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Avanfil 100 or 200mg

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.

Group Type: ACTIVE_COMPARATOR

Avanafil 100 or 200mg

Intervention Type: 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.

Placebo 100mg or 200mg

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.

Group Type: PLACEBO_COMPARATOR

Avanafil 100 or 200mg

Intervention Type: 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.

Interventions

Avanafil 100 or 200mg

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.

Intervention Type: DRUG

Other Intervention Names

Zepeed 100mg or 200mg

Eligibility Criteria

Inclusion Criteria

1. Male patients over 20 years old with a history of erectile dysfunction for at least 6 months prior to participation in the study

2. Patients in a stable relationship with 1 female partner

3. Patients whose sex partner is not in pregnancy or lactating, and is taking proper contraceptive

4. Patients who have voluntarily decided to participate in this clinical trial, and signed the informed consent form

5. 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

6. 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

Exclusion Criteria

1. Patients who have a spinal injury or have had a radical prostatectomy

2. Patients with anatomical malformations of the penis (example: angulation, fibrosis of corpus cavernosum, peyronies disease, etc.)

3. Patients who had surgery in the pelvic cavity within 6 months prior to participation in the study

4. 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.)

5. Patients with a major refractory psychiatric disorder (including major depression or schizophrenia) or significant neurological abnormalities (neurovascular disease)

6. Patients with alcohol addiction or persistent abuse of drugs of dependence

7. 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

8. Diabetic patients whose HbA1c exceeds 12%

9. Patients with proliferative diabetic retinopathy

10. 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

11. 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)

12. Patients with hematopathy, which can be a predisposition to priapism (sickle-cell disease, multiple myeloma, leukemia)

13. Patients with a known genetically degenerative retinopathy, including retinitis pigmentosa

14. Patients who have had experience with avanafil, viagra, cialis, levitra, yaila, zydena, mvix or other ED treatment within 2 weeks from participation in the study

15. Patients administered with the following medications:

• Nitrate/Nitric oxide (NO) donors (example: nitroglycerin, isosorbide mononitrate, amyl nitrate/nitrite, sodium nitroprusside)
• Androgens (example: testosterone), anti-androgen, trazodone
• Anticoagulant (antiplatelet agents excluded)
• Agents that significantly affect the CYP450 3A4 intermediary metabolism, such as erythromycin, intraconazol, ketoconazol, cimetidine, ritonavir, saquinavir, amprenavir, indinavir, and nelfinavir, etc.

16. Patients who have had a history of hypersensitivity to other PDE-5 inhibitors or who have not responded to them

17. Patients with primary hyposexuality

18. Patients who have taken other investigational products within 4 weeks before the study

19. For other reasons besides the aforementioned cases, patient whose participation is deemed inappropriate due to clinically significant findings according to the medical decision of the principal investigator or the study personnel

• Minimum Eligible Age: 20 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

JW Pharmaceutical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kim Se Woong, Doctor

Role: PRINCIPAL_INVESTIGATOR

Catholic hospital in Korea

Locations

Catholic Univ. Seoul St. Mary's Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

임상제도과-2221

Identifier Type: OTHER

Identifier Source: secondary_id

JW-AVA-302

Identifier Type: -

Identifier Source: org_study_id