Table of Contents
- Trial overview
- Post-surgery rehabilitation studies
- Newborn brain injury study
- Fontan operation study
- Migraine study
- What the trials measure
Trial overview
These studies are all looking at Sildenafil in different patient groups and for different goals.[1][2][3][4][5]
The trial set includes interventional studies, which means the researchers give one treatment or another and then compare the results.[1][2][3][4][5]
The study phases range from Phase 1 to Phase 4, so the data include both early testing and later research.[2][4][5]
Post-surgery rehabilitation studies
Two trials study recovery of sexual function after cancer surgery in men.[1][3]
The PEHAB II study is in men after nerve-sparing radical prostatectomy, which is prostate surgery that tries to protect nerves linked to erections.[1]
This Phase 3 trial compares 12 months of daily Sildenafil plus a vacuum erection device with Sildenafil taken on demand, and it measures return to adequate spontaneous unassisted erections at 24 months.[1]
The RECTIL trial studies men treated with proctectomy for rectal cancer, which means surgery to remove part or all of the rectum.[3]
This Phase 3 randomized trial compares Sildenafil with placebo and checks whether patients reach a score of at least 22 on the erectile function part of the International Index of Erectile Function at 12 months after surgery.[3]
Newborn brain injury study
One Phase 4 trial studies newborns with hypoxic ischemic encephalopathy, a brain injury caused by too little oxygen and blood flow.[2]
This study is randomized, double-blinded, placebo-controlled, and multicenter, which means the treatment is compared fairly across several hospitals and neither families nor study staff know who gets which treatment during the trial.[2]
The trial has two steps: first it measures plasma concentrations of Sildenafil, and then it checks survival without brain lesions on MRI at hospital discharge.[2]
The study includes term neonates born after 36 weeks of gestation and uses controlled hypothermia, which means carefully lowering body temperature as part of treatment.[2]
Fontan operation study
One Phase 3 pilot study looks at adults with a functionally single ventricle after a Fontan operation.[4]
A functionally single ventricle means one heart pumping chamber is not fully developed or does not work normally, so the circulation is repaired in stages with a Fontan operation.[4]
The study asks whether adding Sildenafil to existing therapy improves physical performance in stable patients who do not need cardiac catheterization, which is a test where a thin tube is placed into the heart vessels.[4]
The main endpoint is the increase in peak oxygen uptake on ergospirometry after 24 weeks, which shows how well the body uses oxygen during exercise.[4]
Migraine study
One Phase 1 completed study looked at men and women with migraine without aura, meaning migraine attacks without warning symptoms such as flashing lights or numbness.[5]
The trial compared Sildenafil with placebo and also included other medicines in the protocol, but the main focus was the headache-inducing effects of Sildenafil.[5]
Researchers measured the difference in migraine-like attacks in men and compared migraine-like attacks in Sildenafil-treated men and women.[5]
What the trials measure
The main outcomes in these studies are very different because each trial has a different goal.[1][2][3][4][5]
- Erection recovery: two studies measure whether patients regain unassisted erections or reach a defined erectile function score after surgery.[1][3]
- Brain MRI outcome: one newborn study checks survival without brain lesions on MRI at discharge.[2]
- Drug levels in blood: one newborn study first measures plasma concentrations of Sildenafil.[2]
- Exercise capacity: one heart study measures peak oxygen uptake after 24 weeks of treatment.[4]
- Headache events: one migraine study measures how often migraine-like attacks occur after Sildenafil.[5]
