Erectile DysfunctionPhase 2NCT02477436
Efficacy and Safety of Avanafil in the Patients With Erectile Dysfunction
A Phase 2 study testing Avanafil in people with Erectile Dysfunction, run by Pusan National University Hospital at 1 site in South Korea.
Trial summary
This is an exploratory clinical study to presume the optimum usage and dosage for a therapeutic confirmatory study by evaluating the efficacy and safety of Avanafil 50mg, 100mg, 200mg or placebo administered orally in patients with erectile dysfunction. Read more about this study
- Who is it for?
- Ages 19 to 70 years, men only
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- Avanafil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 159 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2008to Sep 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The male subjects who were aged 19 ~ 70 with history of erectile dysfunction for at least 6 months duration
- The subjects who had had stable monogamous relationships with their female partners
- Their partners were free from pregnancy and lactation and well prevent conception
- The subjects who were judged to be suitable to the clinical study in consequence of screening test
- The subjects who consented to participate in the clinical study in writing
- The subjects who attempted sexual intercourses at least 4 times in separate days during 4 weeks' free run-in period, and whose failure rate was over 50%.
- The subjects whose point were between 11 and 25 in EF domain of IIEF after 4 weeks' free run-in period
Who cannot join
- The following cases were excluded from this clinical study.
- The subjects who had spinal cord injury or who underwent radical prostatectomy
- The subjects whose penises were anatomically deformed (Ex: server penile fibrosis, and Peyronie's disease)
- The subjects who had erectile dysfunction due to neurogenic or endocrine cause (hyperprolactinemia, low serum testosterone levels, etc.)
- Hyperprolactinemia: serum prolactin over 3 times higher than the upper limit
- Low Testosterone: serum total testosterone less than the lower limit
Show all 30Show fewer
- The subjects who had uncontrolled major psychiatric disorder and did not accept therapies (includes major depressions and schizophrenia) or had significant neurological abnormalities (neurovascular disorder)
- The subjects who underwent cancer chemotherapy within 1 year
- The subjects who were addicted to alcohol or who had continuously misused dependent drugs
- The subjects who had hepatic dysfunction or renal dysfunction as in the following:
- Hepatic Dysfunction: GOT and GPT (glutamate-pyruvate transaminase) were three times higher than the upper limit
- Renal Dysfunction: serum creatinine was over 2.0mg/dl
- The subjects who had uncontrollable diabetes (FPG>180mg/dL)
- The subjects who had proliferative diabetic retinopathy
- The subjects who suffered from stroke, transient ischemic attacks, myocardial infarction, heart failure that needed to be medically treated, unstable angina or fatal arrhythmia or who underwent coronary artery bypass graft within 6 months
- The subjects had serious hypotension (SBP/DBP(diastolic blood pressure) is less than 90/50mmHg in a sitting posture) or uncontrollable severe hypertension (SBP/DBP is over 170/100mmHg in a sitting posture)
- The subjects who had hematological disorders that was likely to be developed into priapism such as sickle cell disease, multiple myeloma, leukemia
- The subjects who had retinitis pigmentosa
- The subjects who suffered from serious GI bleeding disorder within 1 year
- The subjects who took Viagra®, Cialis®, Levitra®, Mvix® and others within 2 weeks before the clinical study
- The subjects who had taken the following drugs
- ① Nitrate/Nitric oxide(NO) donors(ex. Nitroglycerin, isosorbide mononitrate, amyl nitrate/nitrite, sodium nitroprusside)
- ② Androgens(ex testosterone), anti-androgen, trazodone
- ③ Anticoagulant (excludes antiplatelet drugs)
- ④ Erythromycin, itraconazole, ketoconazole, cimetidine, ritonavir, saquinavir, amprenavir, indinavir and nelfinavir that greatly affects CYP3A4 (cytochrome P450 isoenzyme 3A4)
- The subjects who had history of hypersensitivity to the PDE(phosphodiesterase)-5 inhibitors or whose erectile dysfunction was not improved
- The subjects who had hypoactive sexual desire
- The subjects who had no intention of having sexual intercourses 4 times in separate days during 4 weeks' free run-in period
- The subjects who took other study drugs within 30 days before this clinical study
- The subjects who were judged to be unsuitable to the clinical study by other reasons
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Urology, Pusan National University Hospital
Busan, 602-739
About this study
Official title: A Randomized, Placebo Controlled, Double Blind, Multicenter Therapeutic Exploratory Clinical Study for the Evaluation of the Efficacy and Safety of Avanafil in the Patients With Erectile Dysfunction
This is an exploratory clinical study to presume the optimum usage and dosage for a therapeutic confirmatory study by evaluating the efficacy and safety of Avanafil 50mg, 100mg, 200mg or placebo administered orally in patients with erectile dysfunction. In conclusions, Patients with erectile dysfunction (ED) were administered placebo, Avanafil 50mg, 100mg or 200mg 30 minutes before sexual intercourse for 8 weeks.
Read the detailed description
- Study design: Prospective, randomized, double blind, placebo-controlled, therapeutic exploratory clinical study Usage \& period One capsule was administered 30minutes before sexual intercourse.It was administered only once a day.
[Evaluation endpoints]
- Safety: ① Laboratory tests: Hematological Test, Blood chemical Test, Urinalysis Vital signs: blood pressure, pulse rate ③ Adverse events and Adverse drug reaction ④12-lead ECG
- Efficacy
- Primary endpoint ▪ The change of erectile function (EF) domain score in the international index of erectile function (IIEF)
- Secondary endpoint ▪ The change of success rate in sexual encounter profile (SEP) questionnaire 2, questionnaire 3, questionnaire 4 and questionnaire 5 ▪ The change of score in IIEF questionnaire 3 and questionnaire 4, The change of score in other domains of IIEF, GEAQ (Global efficacy assessment question), Normal erectile function (IIEF EF domain score ≥ 26) rate Statistical methods
- Definition of Evaluation population Maximum efficacy evaluation population included the subjects who satisfied inclusion criteria, who took the investigational product at least once, who visited the hospital after taking the investigational product, and who got the result of efficacy evaluation. Safety-Evaluation Population consisted of the subjects who made a visit after taking the investigational product once or more and who got follow-up safety results
- Initial Comparability Discrete variables were comparatively analyzed by χ2-test, Fisher's exact test, and Successive variables were comparatively analyzed by ANOVA test or Kruskal-Wallis test.
- Efficacy Evaluation The change of EF domain score in the IIEF: Analysis of covariance(ANCOVA), in which baseline was corrected, was performed to check whether there was a difference between the placebo group and the Avanafil groups in change of EF domain score. The change of score in other domains of IIEF: Analysis of covariance(ANCOVA), in which baseline was corrected, was performed to check whether there was a difference between the placebo group and the Avanafil groups. The change of score in IIEF questionnaire 3 and questionnaire 4: Analysis of covariance(ANCOVA), in which baseline was corrected, was performed to check whether there was a difference between the placebo group and the Avanafil groups in IIEF questionnaire 3, questionnaire 4 respectively. The change of success rate in SEP questionnaire 2, questionnaire 3, questionnaire 4 and questionnaire 5: Analysis of covariance(ANCOVA), in which baseline was corrected, was performed to check whether there was a difference between the placebo group and the Avanafil groups. GEAQ (Global Efficacy Assessment Question) : The difference of GEAQ between groups was analyzed by χ2-test. Normal erectile function(IIEF EF domain score ≥ 26) rate: The difference of Normal erectile function rate between groups was analyzed by χ2-test. The efficacy results were analyzed by Dunnett's or Bonferroni's multiple comparison test to check whether there was a significant difference between the placebo group and the Avanafil groups.
- Safety Evaluation Adverse Events and Adverse Drug Reaction: The difference between the placebo group and the Avanafil groups was compared by using χ2-test or Fisher's exact test. Adverse events reported in study subjects were presented by WHOART (World Health Organization Adverse Reaction Terminology) system organ class. The adverse drug reactions, related with the investigational product, were comparatively verified on the same method.
All statistical analyses were performed under significance level 5%, test power 80% and two-side test.
- Conditions
- Erectile Dysfunction
- Being tested
- Avanafil, Placebo
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AvanafilDrug
Also called Phosphodiesterase 5 inhibitor
- One capsule should be taken with water, 30 minutes before sexual intercourse. It should be taken only once a day.
- Intemperance in eating and drinking should not be done, 2 hours before and 2 hour after taking the investigational product.
- Investigational products were administered prior to the sexual intercourse for total 8 weeks.
PlaceboDrug
- One capsule should be taken with water, 30 minutes before sexual intercourse. It should be taken only once a day.
- Intemperance in eating and drinking should not be done, 2 hours before and 2 hour after taking the placebo.
- Placebos were administered prior to the sexual intercourse for total 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Avanafil 50mg group | Experimental | Avanafil 50mg tablet + Placebo 100mg tablet Receives: Drug: Avanafil |
| Avanafil 100mg group | Experimental | Avanafil 100mg tablet + Placebo 100mg tablet Receives: Drug: Avanafil |
| Avanafil 200mg group | Experimental | Avanafil 100mg 2 tablets Receives: Drug: Avanafil |
| Placebo group | Placebo comparator | Placebo 100mg 2tablets Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of erectile (EF) domain score in the international index of erectile function (IIEF) questionnaire
Measured: Week 4 and 8
Secondary outcomes (5)
The change of success rate for SEP (Sexual encounter profile) questionnaire 2,3,4 and 5
Measured: Week 4 and 8
The change of score in orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction domains in international index of erectile function (IIEF)
Measured: Week 4 and 8
The change of score in the international index of erectile function (IIEF) questionnaire 3 and 4
Measured: Week 4 and 8
Improvement of erection on the GEAQ (Global Efficacy Assessment Question) questionnaire
The GEAQ question, 'Has the treatment you have been over the past 8weeks improved your erections?'
Measured: Week 4 and 8
Normal erectile function (IIEF EF domain score ≥ 26) rate
Measured: Week 4 and 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2015 (estimated)
- Study startFeb 2008
- Primary completionSep 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Erectile DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pusan National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hyun Jun Park, PhD, MD, Principal investigator, Department of Urology, Pusan National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02477436
- Sponsor's protocol ID
- Avanafil-Korea
- Status last verified
- Jun 2015
- First submitted
- 3 Jun 2015
- Last updated
- 24 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Park HJ, Kim SW, Kim JJ, Lee SW, Paick JS, Ahn TY, Park K, Park JK, Park NC. A Randomized, Placebo-Controlled, Double-Blind, Multi-Center Therapeutic Confirmatory Study to Evaluate the Safety and Efficacy of Avanafil in Korean Patients with Erectile Dysfunction. J Korean Med Sci. 2017 Jun;32(6):1016-1023. doi: 10.3346/jkms.2017.32.6.1016.
PubMed 28480661
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo Controlled, Double Blind, Multicenter Therapeutic Exploratory Clinical Study for the Evaluation of the Efficacy and Safety of Avanafil in the Patients With Erectile Dysfunction
- ClinicalTrials.gov ID
- NCT02477436
- Acronym / sponsor ID
- Avanafil-Korea
- Conditions
- Erectile Dysfunction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- Pusan National University HospitalUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 22 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an exploratory clinical study to presume the optimum usage and dosage for a therapeutic confirmatory study by evaluating the efficacy and safety of Avanafil 50mg, 100mg, 200mg or placebo administered orally in patients with erectile dysfunction. In conclusions, Patients with erectile dysfunction (ED) were administered placebo, Avanafil 50mg, 100mg or 200mg 30 minutes before sexual intercourse for 8 weeks.
Detailed description
- Study design: Prospective, randomized, double blind, placebo-controlled, therapeutic exploratory clinical study Usage \& period One capsule was administered 30minutes before sexual intercourse.It was administered only once a day.
[Evaluation endpoints]
- Safety: ① Laboratory tests: Hematological Test, Blood chemical Test, Urinalysis Vital signs: blood pressure, pulse rate ③ Adverse events and Adverse drug reaction ④12-lead ECG
- Efficacy
- Primary endpoint ▪ The change of erectile function (EF) domain score in the international index of erectile function (IIEF)
- Secondary endpoint ▪ The change of success rate in sexual encounter profile (SEP) questionnaire 2, questionnaire 3, questionnaire 4 and questionnaire 5 ▪ The change of score in IIEF questionnaire 3 and questionnaire 4, The change of score in other domains of IIEF, GEAQ (Global efficacy assessment question), Normal erectile function (IIEF EF domain score ≥ 26) rate Statistical methods
- Definition of Evaluation population Maximum efficacy evaluation population included the subjects who satisfied inclusion criteria, who took the investigational product at least once, who visited the hospital after taking the investigational product, and who got the result of efficacy evaluation. Safety-Evaluation Population consisted of the subjects who made a visit after taking the investigational product once or more and who got follow-up safety results
- Initial Comparability Discrete variables were comparatively analyzed by χ2-test, Fisher's exact test, and Successive variables were comparatively analyzed by ANOVA test or Kruskal-Wallis test.
- Efficacy Evaluation The change of EF domain score in the IIEF: Analysis of covariance(ANCOVA), in which baseline was corrected, was performed to check whether there was a difference between the placebo group and the Avanafil groups in change of EF domain score. The change of score in other domains of IIEF: Analysis of covariance(ANCOVA), in which baseline was corrected, was performed to check whether there was a difference between the placebo group and the Avanafil groups. The change of score in IIEF questionnaire 3 and questionnaire 4: Analysis of covariance(ANCOVA), in which baseline was corrected, was performed to check whether there was a difference between the placebo group and the Avanafil groups in IIEF questionnaire 3, questionnaire 4 respectively. The change of success rate in SEP questionnaire 2, questionnaire 3, questionnaire 4 and questionnaire 5: Analysis of covariance(ANCOVA), in which baseline was corrected, was performed to check whether there was a difference between the placebo group and the Avanafil groups. GEAQ (Global Efficacy Assessment Question) : The difference of GEAQ between groups was analyzed by χ2-test. Normal erectile function(IIEF EF domain score ≥ 26) rate: The difference of Normal erectile function rate between groups was analyzed by χ2-test. The efficacy results were analyzed by Dunnett's or Bonferroni's multiple comparison test to check whether there was a significant difference between the placebo group and the Avanafil groups.
- Safety Evaluation Adverse Events and Adverse Drug Reaction: The difference between the placebo group and the Avanafil groups was compared by using χ2-test or Fisher's exact test. Adverse events reported in study subjects were presented by WHOART (World Health Organization Adverse Reaction Terminology) system organ class. The adverse drug reactions, related with the investigational product, were comparatively verified on the same method.
All statistical analyses were performed under significance level 5%, test power 80% and two-side test.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Avanafil 50mg group | Experimental | Drug: AvanafilAvanafil 50mg tablet + Placebo 100mg tablet |
| Avanafil 100mg group | Experimental | Drug: AvanafilAvanafil 100mg tablet + Placebo 100mg tablet |
| Avanafil 200mg group | Experimental | Drug: AvanafilAvanafil 100mg 2 tablets |
| Placebo group | Placebo comparator | Drug: PlaceboPlacebo 100mg 2tablets |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- The male subjects who were aged 19 ~ 70 with history of erectile dysfunction for at least 6 months duration
- The subjects who had had stable monogamous relationships with their female partners
- Their partners were free from pregnancy and lactation and well prevent conception
- The subjects who were judged to be suitable to the clinical study in consequence of screening test
- The subjects who consented to participate in the clinical study in writing
Key exclusion criteria (30 listed)
- The following cases were excluded from this clinical study.
- The subjects who had spinal cord injury or who underwent radical prostatectomy
- The subjects whose penises were anatomically deformed (Ex: server penile fibrosis, and Peyronie's disease)
- The subjects who had erectile dysfunction due to neurogenic or endocrine cause (hyperprolactinemia, low serum testosterone levels, etc.)
- The subjects who had uncontrolled major psychiatric disorder and did not accept therapies (includes major depressions and schizophrenia) or had significant neurological abnormalities (neurovascular disorder)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AvanafilAlso: Phosphodiesterase 5 inhibitor* One capsule should be taken with water, 30 minutes before sexual intercourse. It should be taken only once a day. * Intemperance in eating and drinking should not be done, 2 hours before and 2 hour after taking the investigational product. * Investigational products were administered prior to the sexual intercourse for total 8 weeks. | Drug | Avanafil 100mg group, Avanafil 200mg group, Avanafil 50mg group |
| Placebo* One capsule should be taken with water, 30 minutes before sexual intercourse. It should be taken only once a day. * Intemperance in eating and drinking should not be done, 2 hours before and 2 hour after taking the placebo. * Placebos were administered prior to the sexual intercourse for total 8 weeks. | Drug | Placebo group |
Primary outcome
Change of erectile (EF) domain score in the international index of erectile function (IIEF) questionnaire
Time frame: Week 4 and 8
5 secondary outcomes
The change of success rate for SEP (Sexual encounter profile) questionnaire 2,3,4 and 5
Time frame: Week 4 and 8
The change of score in orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction domains in international index of erectile function (IIEF)
Time frame: Week 4 and 8
The change of score in the international index of erectile function (IIEF) questionnaire 3 and 4
Time frame: Week 4 and 8
Improvement of erection on the GEAQ (Global Efficacy Assessment Question) questionnaire
Time frame: Week 4 and 8
Normal erectile function (IIEF EF domain score ≥ 26) rate
Time frame: Week 4 and 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2015.
- Derived from this study: PubMed 28480661Park HJ, Kim SW, Kim JJ, Lee SW, Paick JS, Ahn TY, Park K, Park JK, Park NC. A Randomized, Placebo-Controlled, Double-Blind, Multi-Center Therapeutic Confirmatory Study to Evaluate the Safety and Efficacy of Avanafil in Korean Patients with Erectile Dysfunction. J Korean Med Sci. 2017 Jun;32(6):1016-1023. doi: 10.3346/jkms.2017.32.6.1016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hyun Jun Park, PhD, MD principal investigator
Department of Urology, Pusan National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Avanafil in people with Erectile Dysfunction, run by Pusan National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of erectile (EF) domain score in the international index of erectile function (IIEF) questionnaire (time frame: Week 4 and 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02477436, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2015.