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 @ 10:00 PM
Ignite Modification Date:
2025-12-24 @ 10:00 PM
NCT ID:
NCT05458232
Eligibility Criteria:
Inclusion Criteria:
* Ages 60-75 yrs
* Recently prescribed 5mg of tadalafil daily for clinical purposes
Exclusion Criteria:
* History of diabetes
* history of hypotension including orthostatic hypotension
* History of malignancy or chemo/radiation therapy in the 6 months prior to enrollment
* History of short gut syndrome, gastrointestinal bypass/reduction surgery (Lap band, gastric sleeve, etc.)
* Subjects who cannot refrain from using protein or amino acid supplements for 7 days prior to Visit 2 and 3.
* Alcohol consumption of ≥ 5 units/servings per day
* Concomitant use of
* oral or injectable corticosteroids
* testosterone, insulin like growth factor-1, or similar anabolic agent
* riociguat (Adempas)
* nitroglycerin
* isosorbide dinitrate (Isordil)
* isosorbide mononitrate (Imdur, Monoket)
* doxazosin (Cardura)
* prazosin (Minipress)
* terazosin (Hytrin)
* Any other disease or condition that would place the subject at increased risk of harm if they were to participate, at the discretion of the study physician
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
60 Years
Maximum Age:
75 Years
Study:
NCT05458232
Study Brief:
Protocol Section:
NCT05458232