A Study of DA-8159 in Subjects With Erectile Dysfunction
A Randomized, Placebo-Controlled, Double-Blind, Parallel Design Phase 2 Dose Ranging Trial To Assess The Safety and Efficacy of DA-8159 Tablets in Male Subjects With Erectile Dysfunction.
1 other identifier
interventional
300
1 country
15
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 with erectile dysfunction (ED).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2005
Shorter than P25 for phase_2
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2005
CompletedFirst Submitted
Initial submission to the registry
January 25, 2006
CompletedFirst Posted
Study publicly available on registry
January 27, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2006
CompletedFebruary 28, 2007
February 1, 2007
January 25, 2006
February 27, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
The primary efficacy end points are:
the change in score (baseline to Visit 5) for the Erectile Function domain score of the IIEF;
change in response, relative to baseline, for sexual encounter profile (SEP) question 2, and
change in response, relative to baseline, for SEP question 3.
Safety will be assessed by monitoring adverse events and changes in vital signs, clinical laboratory test results, 12-lead ECG, and physical examinations.
Secondary Outcomes (5)
The study has several secondary efficacy measurements including:
changes in the satisfaction of intercourse, orgasmic function, sexual desire and overall satisfaction domains of the IIEF,
changes from baseline in SEP questions 1, 4 and 5;
the global assessment questionnaire (GAQ), and
changes from baseline in patient self assessment questionnaire (PSAE) scores.
Interventions
Eligibility Criteria
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.
- +17 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
Medical Affiliated Research Center
Huntsville, Alabama, 35801, United States
The Male Clinic
Beverly Hills, California, 90212, United States
South Orange County
Laguna Woods, California, 92653, United States
California Profession Research
Newport Beach, California, 92660, United States
West Coast Clinical Research
Tarzana, California, 91356, United States
Urology Research Options
Aurora, Colorado, 80012, United States
Connecticut Clinical Research Center
Waterbury, Connecticut, 06708, United States
South Florida Medical Research
Aventura, Florida, 33180, United States
Florida Foundation for Healthcare Research
Ocala, Florida, 34474, United States
Northeast Indiana Research, LLC
Fort Wayne, Indiana, 46825, United States
Drs. Werner, Murdock & Francis, P.A. , Urology Associates
Greenbelt, Maryland, 20770, United States
Accumed Research Associates
Garden City, New York, 11530, United States
Center for Urologic Research of Western New York
Williamsville, New York, 14221, United States
University Urological Researcgh Institute
Providence, Rhode Island, 02904, United States
Urology San Antonio Research
San Antonio, Texas, 78229, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
James L Yeager, RPh., Ph.D.
- PRINCIPAL INVESTIGATOR
Harin Padma-Nathan, MD
The Male Clinic
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
January 25, 2006
First Posted
January 27, 2006
Study Start
May 1, 2005
Study Completion
June 1, 2006
Last Updated
February 28, 2007
Record last verified: 2007-02