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 @ 11:29 PM
Ignite Modification Date:
2025-12-24 @ 11:29 PM
NCT ID:
NCT00379756
Eligibility Criteria:
Inclusion criteria:
* Males with ED for more than six months, according to the NIH Consensus Statement (inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance).
* Stable heterosexual relationship for more than 6 months.
* The subject must make at least four attempts at sexual intercourse (according to the question in the subject diary: Was sexual activity initiated with the intention of intercourse?) on four separate days during the untreated baseline period. At least 50% of attempts during this period must be unsuccessful, according to the following questions from the subject diary \[at least one question should be answered "No"\]: Were you able to achieve at least some erection (some enlargement of the penis)? Were you able to insert your penis into your partner's vagina? Did your erection last long enough for you to have successful intercourse?
* Diagnosis of dyslipidemia treated with a stable dose of a statin for 6 months at Visit 1.
* IIEF-EF domain score of 25 denoting mild to severe ED at Visit 2.
* Documented, dated, written Informed Consent.
Exclusion criteria:
* Premature ejaculator \<2 minutes
* Any unstable medical, psychiatric, spinal cord injury, penile anatomical abnormalities, or substance abuse disorder that MD feels subject will not be able to complete the study.
* Low sexual desire.
* Prior prostatectomy surgery
* Severe chronic or acute liver disease, history of moderate or severe liver impairment
* Clinically significant chronic hematological disease
* Bleeding disorder or significant active peptic ulceration.
* Cardiovascular conditions that prevent sexual activity.
* History of heart attack, stroke, or life-threatening arrhythmia within the prior 6 months.
* hypotension or hypertension at rest.
* cancer within the past 5 years. Use of these medications: nitrates or nitric oxide donors, anti-androgens, oral or injectable androgens, received any investigational drug (including placebo) within 30 days of screening (Visit 1).
* Use of any treatment for ED within 7 days of screening including oral medications, vacuum devices, constrictive devices, injections or urethral suppositories.
* Subjects who are taking the following potent inhibitors of cytochrome P-450 3A4.
* Abnormal Laboratory Values:
1. serum total testosterone level \>25% below the lower limit of normal
2. serum creatinine \>3.0 mg/dl.
3. AST and/or ALT \>3x the upper limit of normal.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
64 Years
Study:
NCT00379756
Study Brief:
Protocol Section:
NCT00379756