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Efficacy and Safety of Avanafil in the Patients With Erectile Dysfunction

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ClinicalTrials.gov Identifier: NCT02477436
Recruitment Status : Completed
First Posted : June 22, 2015
Last Update Posted : June 24, 2015
Sponsor:
Information provided by (Responsible Party):
Pusan National University Hospital

Brief 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. In conclusions, Patients with erectile dysfunction (ED) were administered placebo, Avanafil 50mg, 100mg or 200mg 30 minutes before sexual intercourse for 8 weeks.

Condition or disease Intervention/treatment Phase
Erectile Dysfunction Drug: Avanafil Drug: Placebo Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 159 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : February 2008
Actual Primary Completion Date : September 2008
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Avanafil

Arm Intervention/treatment
Experimental: Avanafil 50mg group
Avanafil 50mg tablet + Placebo 100mg tablet
Drug: Avanafil
  • 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.
Other Name: Phosphodiesterase 5 inhibitor

Experimental: Avanafil 100mg group
Avanafil 100mg tablet + Placebo 100mg tablet
Drug: Avanafil
  • 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.
Other Name: Phosphodiesterase 5 inhibitor

Experimental: Avanafil 200mg group
Avanafil 100mg 2 tablets
Drug: Avanafil
  • 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.
Other Name: Phosphodiesterase 5 inhibitor

Placebo Comparator: Placebo group
Placebo 100mg 2tablets
Drug: 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.




Primary Outcome Measures :
  1. Change of erectile (EF) domain score in the international index of erectile function (IIEF) questionnaire [ Time Frame: Week 4 and 8 ]

Secondary Outcome Measures :
  1. The change of success rate for SEP (Sexual encounter profile) questionnaire 2,3,4 and 5 [ Time Frame: Week 4 and 8 ]
  2. 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 ]
  3. The change of score in the international index of erectile function (IIEF) questionnaire 3 and 4 [ Time Frame: Week 4 and 8 ]
  4. Improvement of erection on the GEAQ (Global Efficacy Assessment Question) questionnaire [ Time Frame: Week 4 and 8 ]
    The GEAQ question, 'Has the treatment you have been over the past 8weeks improved your erections?'

  5. Normal erectile function (IIEF EF domain score ≥ 26) rate [ Time Frame: Week 4 and 8 ]


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Ages Eligible for Study:   19 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. The male subjects who were aged 19 ~ 70 with history of erectile dysfunction for at least 6 months duration
  2. The subjects who had had stable monogamous relationships with their female partners
  3. Their partners were free from pregnancy and lactation and well prevent conception
  4. The subjects who were judged to be suitable to the clinical study in consequence of screening test
  5. The subjects who consented to participate in the clinical study in writing
  6. 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%.
  7. The subjects whose point were between 11 and 25 in EF domain of IIEF after 4 weeks' free run-in period

Exclusion Criteria:

The following cases were excluded from this clinical study.

  1. The subjects who had spinal cord injury or who underwent radical prostatectomy
  2. The subjects whose penises were anatomically deformed (Ex: server penile fibrosis, and Peyronie's disease)
  3. 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
  4. 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)
  5. The subjects who underwent cancer chemotherapy within 1 year
  6. The subjects who were addicted to alcohol or who had continuously misused dependent drugs
  7. 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
  8. The subjects who had uncontrollable diabetes (FPG>180mg/dL)
  9. The subjects who had proliferative diabetic retinopathy
  10. 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
  11. 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)
  12. The subjects who had hematological disorders that was likely to be developed into priapism such as sickle cell disease, multiple myeloma, leukemia
  13. The subjects who had retinitis pigmentosa
  14. The subjects who suffered from serious GI bleeding disorder within 1 year
  15. The subjects who took Viagra®, Cialis®, Levitra®, Mvix® and others within 2 weeks before the clinical study
  16. 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)

  17. The subjects who had history of hypersensitivity to the PDE(phosphodiesterase)-5 inhibitors or whose erectile dysfunction was not improved
  18. The subjects who had hypoactive sexual desire
  19. The subjects who had no intention of having sexual intercourses 4 times in separate days during 4 weeks' free run-in period
  20. The subjects who took other study drugs within 30 days before this clinical study
  21. The subjects who were judged to be unsuitable to the clinical study by other reasons

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02477436


Locations
Korea, Republic of
Department of Urology, Pusan National University Hospital
Busan, Korea, Republic of, 602-739
Sponsors and Collaborators
Pusan National University Hospital
Investigators
Principal Investigator: Hyun Jun Park, PhD, MD Department of Urology, Pusan National University Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pusan National University Hospital
ClinicalTrials.gov Identifier: NCT02477436     History of Changes
Other Study ID Numbers: Avanafil-Korea
First Posted: June 22, 2015    Key Record Dates
Last Update Posted: June 24, 2015
Last Verified: June 2015

Additional relevant MeSH terms:
Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action