Erectile Dysfunction Clinical Trial
— SPEEDOfficial 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.
Verified date | March 2017 |
Source | JW Pharmaceutical |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 195 |
Est. completion date | November 2013 |
Est. primary completion date | April 2013 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 20 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Catholic Univ. Seoul St. Mary's Hospital | Seoul |
Lead Sponsor | Collaborator |
---|---|
JW Pharmaceutical |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | We will be confirming the safety after initiating treatment with Avanafil 100mg and later increasing to 200mg, compared with continuing treatment with Avanafil 100mg. | Comparative evaluate the variables of the study group and control group after medication: physical exam, vital sign(BP, pulse), ECG(Electrocardiogram, ECG=EKG), Laboratory tests, Adverse events We will check or confirm adverse events related to rates of adverse drug reactions and the disappearance time of adverse events. |
12weeks | |
Primary | 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 | Compare with the MSHQ, SEP Q2, SEP Q3 and GEAQ. | When a dose is increased to 200mg because the effect is insufficient after 4 weeks of medication with Avanafil 100mg, it is to evaluate the effect of a dosage increase in IIEF EF domain, SEP Q2 and Q3. It is to evaluate changes in SEP (Q2, Q3, Q4 and Q5), other domains of IIEF (such as OF, SD, IS and OS domain), IIEF Q3, IIEF Q4, MSHQ, rate of subjects who score 26 and over in EF domain, GEAQ of the study group and control group compared to the baseline after 12 weeks post medication. Change in total score of IIEF EF domain, SEP Q2 and Q3; Comparison between the result from the 12th week and the result from the baseline and the 4th week. [Glossary] MSHQ: Male Sexual Health Questionnaire SEP: Sexual Encounter Profile SEP Q2: Intercourse success rates on the Sexual Encounter Profile SEP Q3: Erectile success rates on the Sexual Encounter Profile GEAQ:Global Assessment Question |
12 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT05366504 -
LiST Plus PRP Injection Therapy vs LiST Monotherapy for ED Treatment
|
Phase 2/Phase 3 | |
Recruiting |
NCT02573805 -
the Diagnostic Value of Rigiscan Test (Nocturnal Penile Tumescence and Rigidity, NPTR) in Chinese Males
|
N/A | |
Recruiting |
NCT02745808 -
Injectable Collagen Scaffold™ Combined With HUC-MSCs for the Improvement of Erectile Function in Men With Diabetes
|
Phase 1 | |
Withdrawn |
NCT02579148 -
Collagen Scaffolds Loaded With HUCMSCs for the Improvement of Erectile Function in Men With Diabetes
|
Phase 1 | |
Withdrawn |
NCT01967251 -
Efficacy, Safety and Dose-response of Udenafil in Patients With Benign Prostatic Hyperplasia and Erectile Dysfunction
|
Phase 2 | |
Recruiting |
NCT02225548 -
Sagene 2014 - Parkinson's Disease and Erectile Dysfunction
|
Phase 4 | |
Completed |
NCT02587988 -
Trial to Evaluate the Efficacy and Safety of HCP1302
|
Phase 3 | |
Completed |
NCT02945462 -
Bone Marrow Mesenchymal Stem Cells in Erectile Dysfunction (ED)
|
Phase 1 | |
Completed |
NCT01937871 -
A Study of Tadalafil in Men With Benign Prostatic Hyperplasia (BPH) and Erectile Dysfunction (ED)
|
Phase 3 | |
Completed |
NCT01698684 -
Research Evaluating a PDE5 Inhibitor for Erectile Dysfunction
|
Phase 4 | |
Not yet recruiting |
NCT01321489 -
A Study to Evaluate a Possible Superiority Expressed by the Faster Onset of Action and the Efficacy and Safety of Sildenafil Citrate 20mg Sublingual Tablet in the Treatment of Erectile Dysfunction of Different Etiologies
|
Phase 3 | |
Completed |
NCT01230541 -
Effect of Udenafil on Spermatogenesis
|
Phase 1 | |
Completed |
NCT02226237 -
Effectiveness of Physiotherapy to Treat the Urinary Incontinence and Erectile Dysfunction Post Retropubic Prostatectomy
|
N/A | |
Terminated |
NCT01262833 -
Pudendal Assessment in Erectile Dysfunction
|
N/A | |
Completed |
NCT01037218 -
Treatment of Erectile Dysfunction II
|
Phase 3 | |
Completed |
NCT01037244 -
Treatment of Erectile Dysfunction I
|
Phase 3 | |
Recruiting |
NCT00313898 -
Effect of Sildenafil on Quality of Sexual Life in Mild to Normally Sexually Functioning Males
|
Phase 4 | |
Completed |
NCT00663728 -
Assessment of Duration of Erection With Vardenafil 10 mg
|
Phase 4 | |
Completed |
NCT00667979 -
Evaluating the Efficacy of Vardenafil in Subjects With Erectile Dysfunction (ED) Administered 12, 18 or 24 Hours Prior to Intercourse
|
Phase 4 | |
Completed |
NCT00421083 -
Efficacy and Safety of Tadalafil in Subjects With Erectile Dysfunction Caused by Spinal Cord Injury
|
Phase 3 |