Efficacy Study of RX-10100 to Treat Erectile Dysfunction (ED)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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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.
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Ages Eligible for Study:
18 Years to 65 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
Following previous or current medical conditions
Any unstable medical, psychiatric, or substance abuse disorder
Penile anatomical abnormalities
Primary hypoactive sexual desire
Spinal cord injury
Stable or unstable angina pectoris
Myocardial infarction, stroke, or life-threatening arrhythmia
Uncontrolled atrial fibrillation/flutter at screening