Efficacy Study of RX-10100 to Treat Erectile Dysfunction (ED)

Completed · Phase 2 · Has a placebo group

Conditions studied: Erectile Dysfunction (ED)

In brief

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 secondary objectives of this trial are to evaluate the safety and the quality of life in subjects with ED receiving RX-10100 treatment.

Key facts

Study ID

NCT00693056

Run by

Rexahn Pharmaceuticals, Inc.

People needed

40

Starts

2008-06-01

Expected to finish

2009-05-01

Last updated by the study team

2009-05-05

Who can join

Age: 18 and older, up to 65. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Greenbelt, Maryland, United States
• Study site — Woodlane, New Jersey, United States
• Study site — Greer, South Carolina, United States

Full record on ClinicalTrials.gov

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