A Study of DA-8159 in Subjects With Erectile Dysfunction

Completed · Phase 2

Conditions studied: Erectile Dysfunction

In brief

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 with erectile dysfunction (ED).

Key facts

Study ID

NCT00282607

Run by

Dong-A PharmTech Co., Ltd.

People needed

300

Starts

2005-05-01

Expected to finish

2006-06-01

Last updated by the study team

2007-02-28

Who can join

Age: 19 and older, up to 75. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Medical Affiliated Research Center — Huntsville, Alabama, United States
• The Male Clinic — Beverly Hills, California, United States
• South Orange County — Laguna Woods, California, United States
• California Profession Research — Newport Beach, California, United States
• West Coast Clinical Research — Tarzana, California, United States
• Urology Research Options — Aurora, Colorado, United States
• Connecticut Clinical Research Center — Waterbury, Connecticut, United States
• South Florida Medical Research — Aventura, Florida, United States
• Florida Foundation for Healthcare Research — Ocala, Florida, United States
• Northeast Indiana Research, LLC — Fort Wayne, Indiana, United States
• Drs. Werner, Murdock & Francis, P.A. , Urology Associates — Greenbelt, Maryland, United States
• Accumed Research Associates — Garden City, New York, United States
• Center for Urologic Research of Western New York — Williamsville, New York, United States
• University Urological Researcgh Institute — Providence, Rhode Island, United States
• Urology San Antonio Research — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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