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Trial · NCT07913477

Registered outcomes45

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
Primarymedical historyat baselineMedical history refers to a comprehensive record of a patient's past and current health conditions, diseases, treatments, and related health events.
SecondaryCDDUat baselineColor Doppler Duplex Ultrasonography
SecondaryIIEF-5at baseline and up to 6 months
The International Index of Erectile Function-5 (IIEF-5) is a validated 5-item self-administered questionnaire used to screen and assess the severity of erectile dysfunction over the preceding 6 months. Each item is scored on a 1-to-5 Likert scale, yielding a total score ranging from 5 (worst) to 25 (best). Severity is classified as follows: 22-25, no ED; 17-21, mild ED; 12-16, mild-to-moderate ED; 8-11, moderate ED; and 5-7, severe ED. Higher total scores indicate better erectile function, while lower scores reflect greater impairment. The IIEF-5 is widely used in both clinical practice and research as a simple, reliable tool for evaluating treatment outcomes.
SecondaryEHSat baseline and at baseline and up to 6 months
The Erection Hardness Score (EHS) is a validated single-item, 4-point self-reported scale used to assess penile rigidity during sexual activity. The scoring criteria are as follows: 1 = the penis is larger but not hard; 2 = the penis is hard but not hard enough for penetration; 3 = the penis is hard enough for penetration but not completely hard; 4 = the penis is completely hard and fully rigid. The total score ranges from 1 (minimum) to 4 (maximum). Higher scores indicate better erection hardness and superior erectile function, while lower scores reflect greater impairment. Due to its simplicity and strong correlation with the IIEF, the EHS is widely used in both clinical practice and research as a quick, reliable tool for monitoring treatment response.
SecondaryALTat baselineAlanine Aminotransferase,a key enzyme mainly found in liver cells, serving as a sensitive biomarker for detecting liver damage.Unit of concentration:U/L
SecondaryASTAT baselineAST stands for Aspartate Aminotransferase, a liver enzyme released into the blood when liver or muscle cells are damaged.Unit of concentration:U/L
SecondaryALPat baseline
ALP stands for Alkaline Phosphatase, a group of enzymes mainly found in the liver, bile ducts, and bones, which is commonly measured in blood tests to help diagnose liver or bone disorders.Unit of concentration:U/L
SecondaryGGTAt baseline
GGT stands for Gamma-Glutamyl Transferase, an enzyme primarily located in the liver, bile ducts, and kidneys, which is commonly measured in blood tests to help diagnose liver, biliary, or pancreatic disorders. Unit of concentration: U/L
SecondaryTBILAT baseline
TBIL stands for Total Bilirubin, a metabolic product mainly formed from the breakdown of aging red blood cells, which is commonly measured in blood tests to help diagnose liver, biliary, or hemolytic disorders. Unit of concentration: μmol/L
SecondaryDBILat baseline
DBIL stands for Direct Bilirubin (also known as Conjugated Bilirubin), a water-soluble pigment mainly formed in the liver through the metabolism of red blood cells, which is commonly measured in blood tests to help diagnose liver, biliary, or hemolytic disorders.Unit of concentration: μmol/L
SecondaryIBILat baseline
IBIL stands for Indirect Bilirubin (also known as Unconjugated Bilirubin), a breakdown product of red blood cells that has not yet been processed by the liver, which is commonly measured in blood tests to help diagnose hemolytic disorders or liver dysfunction. Unit of concentration: μmol/L
SecondaryTPat baseline
TP stands for Total Protein, a measurement of all proteins in the blood serum (primarily albumin and globulins), which is commonly measured in blood tests to help evaluate nutritional status, liver function, kidney function, or immune disorders. Unit of concentration: g/L
SecondaryALBat baseline
ALB stands for Albumin, a protein mainly synthesized by the liver and found in the blood plasma, which is commonly measured in blood tests to help assess liver function, nutritional status, and kidney disorders. Unit of concentration: g/L
SecondaryGLBat baseline
GLB stands for Globulin, a mixture of proteins mainly produced by the immune system, which is commonly measured in blood tests to help diagnose liver diseases, chronic infections, autoimmune disorders, or certain blood cancers. Unit of concentration: g/L
SecondaryA/G ratioat baseline
A/G ratio stands for Albumin/Globulin ratio, a value calculated by dividing the serum albumin level by the globulin level, which is commonly measured in blood tests to help assess liver function and nutritional or immune status. Unit of concentration: dimensionless (ratio).
SecondaryCrat baseline
Cr stands for Creatinine, a waste product generated by muscle metabolism, which is commonly measured in blood and urine tests to help evaluate kidney function and diagnose renal disorders. Unit of concentration: μmol/L
SecondaryBunat baselineBUN stands for Blood Urea Nitrogen, a waste product formed when the liver breaks down protein, which is commonly measured in blood tests to help assess kidney function. Unit of concentration: mmol/L
SecondaryUAat baseline
UA stands for Uric Acid, a waste product formed from the breakdown of purines in the body, which is commonly measured in blood tests to help diagnose gout, kidney disorders, or metabolic abnormalities. Unit of concentration: μmol/L
SecondaryCystatin Cat baseline
Cystatin C , a low-molecular-weight protein produced at a constant rate by all nucleated cells in the body, which is commonly measured in blood tests to help evaluate kidney function, specifically the glomerular filtration rate (GFR), and to detect early kidney damage. Unit of concentration: mg/L
SecondaryeGFRat baseline
eGFR stands for Estimated Glomerular Filtration Rate, a calculated metric that estimates the rate at which the kidneys filter waste from the blood, which is commonly measured in blood tests to help diagnose and stage chronic kidney disease. Unit of concentration: mL/min

Source ClinicalTrials.govtrials-2026-11-12-0.4.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNone stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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