Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2025-12-24 @ 11:36 PM
NCT ID:
NCT00693056
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00693056
Study Brief:
Protocol Section:
NCT00693056