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 @ 1:20 PM
Ignite Modification Date:
2025-12-24 @ 1:20 PM
NCT ID:
NCT01661595
Eligibility Criteria:
Inclusion Criteria:
1. Age 50-60 years of age
2. Ability to sign consent form (score\>23 on the 30-item Mini Mental Status examination, MMSE)
3. Stable body weight for at least three months.
Exclusion Criteria:
1. Physical dependence or frailty (impairment in any of the Activities of Daily Living (ADL), history of falls (\>2/year) or significant weight loss in the past year).
2. Pregnancy
3. Significant heart, liver, kidney, blood or respiratory disease.
4. Peripheral vascular disease.
5. Diabetes mellitus or other untreated endocrine disease.
6. Active cancer
7. Use of nitrates.
8. Recent (within 6 months) treatment with anabolic steroids, or corticosteroids.
9. Alcohol or drug abuse.
10. Severe depression (\>5 on the 15-item Geriatric Depression Scale, GDS).
11. Cardiac abnormalities such as cardiac shunt or previously diagnosed pulmonary hypertension.
12. Systolic blood pressure \<100 or\>150, diastolic blood pressure \<60 or 90\>. This range is smaller than the acceptable range stated in the prescribing information for sildenafil/tadalafil (90/50 and \<170/110).
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
60 Years
Study:
NCT01661595
Study Brief:
Protocol Section:
NCT01661595