Clinical trial NCT01705197: This Study is to Evaluate the Safety and Efficacy of Avanafil in the Treatment of Erectile Dysfunction.
Official title: A Double-blind, Stratified Randomization, Placebo Controlled, Parallel Group, Multicenter, Dose Escalation Study to Evaluate the Efficacy and Safety of Avanafil in Subjects With Moderate to Severe Erectile Dysfunction in Korea.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Erectile Dysfunction
Lead sponsor: JW Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2012-10-12
Enrollment: 195
Sex: MALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Compare with the changes in IIEF(The International Index of Erectile Function)Erectile Function domain score between the study group and control group.
timeFrame: 12 weeks
Secondary outcomes:
measure: Compare with the MSHQ, SEP Q2, SEP Q3 and GEAQ.
timeFrame: 12 weeks
Other outcomes:
measure: We will be confirming the safety after initiating treatment with Avanafil 100mg and later increasing to 200mg, compared with continuing treatment with Avanafil 100mg.
timeFrame: 12weeks
Locations:
city: Seoul
country: Korea, Republic of
facility: Catholic Univ. Seoul St. Mary's Hospital
Study officials:
affiliation: Catholic hospital in Korea
name: Kim Se Woong, Doctor
role: PRINCIPAL_INVESTIGATOR
References: