Status:
COMPLETED
Efficacy Study of RX-10100 to Treat Erectile Dysfunction (ED)
Lead Sponsor:
Rexahn Pharmaceuticals, Inc.
Conditions:
Erectile Dysfunction (ED)
Eligibility:
MALE
18-65 years
Phase:
PHASE2
Brief Summary
The primary objective of this Phase IIa trial is to determine the effective doses and treatment period for an upcoming RX-10100 Phase IIb trial in subjects with erectile dysfunction (ED). The secondar...
Eligibility Criteria
Inclusion
- Have had ED for at least six months
- Stable, heterosexual relationship for at least 3 months
- Make at least one attempt of sexual intercourse per week during the untreated, 2-week screening period
- At least 50% of attempts of sexual intercourse during the untreated baseline period must be unsuccessful
- 'Moderate' or 'mild to moderate' ED, defined as an IIEF-EF domain score between 11 and 21 measured
Exclusion
- Following previous or current medical conditions
- Any unstable medical, psychiatric, or substance abuse disorder
- Penile anatomical abnormalities
- Primary hypoactive sexual desire
- Spinal cord injury
- Hypogonadism
- Surgical prostatectomy
- Stable or unstable angina pectoris
- Myocardial infarction, stroke, or life-threatening arrhythmia
- Uncontrolled atrial fibrillation/flutter at screening
- Severe chronic or acute liver disease
- Moderate or severe hepatic impairment
- Clinically significant chronic hematological disease
- Bleeding disorder
- Significant active peptic ulcer disease
- Resting hypotension or hypertension
- Malignancy (cancers)
- NYHA Class II to IV heart failures
- Positive test for Hepatitis B surface antigen (HBsAg) or Hepatitis C
- Symptomatic postural hypotension
- Following concomitant medication
- Androgens or estrogens
- Anti-androgens
- Potent inhibitors of cytochrome P450 3A4
- Any other investigational drug within 30 days before Visit 1
- Any treatment for ED within 7 days before Visit 1 or during the study
- Antibiotics in the penicillin class
- Following abnormal laboratory values
- Serum total testosterone level (at least 25% lower)
- Serum creatinine (\> 3.0 mg/dl)
- Elevation of AST and/or ALT (\> 3 times the upper limit of normal)
- Diabetic subjects with an HbAlc (\> 6.5%)
- Subjects with known hypersensitivity to amoxicillin
- Subjects with a history of unresponsiveness to any PDE5 Inhibitor treatment or a history of significant side effects leading to its treatment discontinuation
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2009
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00693056
Start Date
June 1 2008
End Date
May 1 2009
Last Update
May 5 2009
Active Locations (3)
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1
Greenbelt, Maryland, United States, 20770
2
Woodlane, New Jersey, United States, 08060
3
Greer, South Carolina, United States, 29651