This Study is to Evaluate the Safety and Efficacy of Avanafil in the Treatment of Erectile Dysfunction. (SPEED)
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|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.|
- Compare with the changes in IIEF(The International Index of Erectile Function)Erectile Function domain score between the study group and control group. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]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.
- Compare with the MSHQ, SEP Q2, SEP Q3 and GEAQ. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- 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
- We will be confirming the safety after initiating treatment with Avanafil 100mg and later increasing to 200mg, compared with continuing treatment with Avanafil 100mg. [ Time Frame: 12weeks ] [ Designated as safety issue: Yes ]
- 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.
|Study Start Date:||February 2012|
|Study Completion Date:||November 2013|
|Primary Completion Date:||April 2013 (Final data collection date for primary outcome measure)|
Active Comparator: 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.
Drug: 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.
Other Name: Zepeed 100mg or 200mg
Placebo Comparator: 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01705197
|Korea, Republic of|
|Catholic Univ. Seoul St. Mary's Hospital|
|Seoul, Korea, Republic of|
|Principal Investigator:||Kim Se Woong, Doctor||Catholic hospital in Korea|