Status:
COMPLETED
A Study of DA-8159 in Subjects With Erectile Dysfunction
Lead Sponsor:
Dong-A PharmTech Co., Ltd.
Conditions:
Erectile Dysfunction
Eligibility:
MALE
19-75 years
Phase:
PHASE2
Brief Summary
The purpose of this study will be to evaluate the clinical efficacy and safety of DA-8159, an orally administered, potent and selective inhibitor of PDE5, versus placebo for the treatment of subjects ...
Detailed Description
This will be a multi-center, randomized, double-blind, placebo-controlled, parallel-group study in 300 erectile dysfunction patients. Patients will complete a screening visit (V1) to determine eligibi...
Eligibility Criteria
Inclusion
- Is male and at least 19 years of age.
- Has a stable monogamous relationship for at least 6 months with a consenting female partner (vaginal intercourse is a required study activity).
- Provides written informed consent.
- The subject's female partner provides written informed consent.
- Has a history of ED (clinically defined as the inability to attain and maintain an erection of the penis sufficient to permit satisfactory sexual intercourse) of at least 3 months duration. The investigator will record the etiology of the ED (organic, psychogenic or mixed).
- Has scored between 6-25 for the Erectile Function domain score (Questions Number 1-5, 15) at both Visits 1 \& 2.
- Completes least four diary entries by Visit 2, showing at least 4 attempts at sexual intercourse with a 50% or greater failure rate in achieving or in maintaining an erection sufficient to complete intercourse (defined as answering "no" to SEP questions #2 or #3).
- The subject's partner is not pregnant or lactating and both subject and partner agree to the use of a medically acceptable form of birth control. Exceptions would be subjects with a vasectomy or partners that are post menopausal, and partners that have had a tubal ligation or hysterectomy.
Exclusion
- Has a history of stroke, myocardial infarction, or coronary artery disease within the past 6 months.
- Has a history of cardiac failure, angina, or life-threatening arrhythmia within the past 6 months.
- Is taking nitrate medication in any form(Appendix 7)
- Is taking alpha blockers.
- Has a clinically significant abnormal laboratory value as determined by the principal investigator.
- Has a history of uncontrolled diabetes (HbA1c\>9%).
- Has a history of proliferative diabetic retinopathy.
- Has a history of spinal cord injury or a radical prostatectomy or radical pelvic surgery.
- Has a supine blood pressure lower than 90/50mmHg or uncontrolled hypertension higher than 170/100mmHg.
- Has a anatomical deformity of the penis such as severe penile fibrosis or Peyronie's disease.
- Has a thyroid stimulating hormone (TSH) level lower than 30% of LLN.
- Has erectile dysfunction caused by neurological or endocrine factors such as hyperprolactinemia or low serum testosterone levels (\<300 ng/dl).
- Has hepatic impairment (GOT, GPT levels \> 3 x ULN).
- Has renal impairment (serum creatinine ≥ 2.5mg/dl).
- Has a history of hematological disorder such as bleeding disorder or a risk of GI bleeding such as peptic ulceration.
- Has a history of retinitis pigmentosa.
- Has a history of sickle cell disease, multiple myeloma, leukemia or any other disorders that may cause priapism.
- Has a history of significant psychiatric disorder.
- Has a history of central nervous system disorders such as stroke, transient ischemic attacks, or spinal cord injury.
- Has a history of drug abuse (alcohol, marijuana, cocaine, or opiates).
- Has a known sensitivity to drugs especially to phosphodiesterase type 5 inhibitors such as Viagra, Cialis or Levitra.
- Has used other erectile dysfunction therapies including nutraceutical and herbal products within 14 days prior to entering into this study.
- Is using concomitant medications that are known or suspected to interact with PDE 5 inhibitors such as the following:
- Antibacterial: erythromycin
- Antifungals: itraconazole, ketoconazole
- Antivirals: ritonavir, saquinavir, amprenavir, indinavir, nelfinavir
- H2 receptor antagonist: cimetidine
- Anticoagulants, androgens, trazodone
- Have other sexual disorders such as hypoactive sexual desire.
- Have previously failed to respond to PDE-5 inhibitors such as Viagra, Cialis or Levitra.
- Have a major illness that in the opinion of the investigator would interfere with the conduct of the study.
- Has not participated in a clinical drug study within the last 30 days prior to entering this study.
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
End Date :
June 1 2006
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT00282607
Start Date
May 1 2005
End Date
June 1 2006
Last Update
February 28 2007
Active Locations (15)
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1
Medical Affiliated Research Center
Huntsville, Alabama, United States, 35801
2
The Male Clinic
Beverly Hills, California, United States, 90212
3
South Orange County
Laguna Woods, California, United States, 92653
4
California Profession Research
Newport Beach, California, United States, 92660