In short
Clinical trials investigating Sildenafil are studying different patient groups, including men after prostate or rectal surgery, newborns with brain injury from low oxygen, patients after Fontan operation, and people with migraine without aura. These trials mainly look at effectiveness, safety, and recovery outcomes in different phases of research.
Key points
- Clinical trials of Sildenafil in the source data study several different patient groups, not just one disease. The main areas are recovery after prostate or rectal cancer surgery, treatment support after Fontan operation, newborn brain injury after low oxygen, and migraine without aura. The trials include Phase 1, Phase 3, and Phase 4 research, showing both early testing and later-stage evaluation. Some studies focus on recovery outcomes, while others measure brain MRI results, exercise performance, blood levels, or headache events. The target populations include adults, newborns, and both men and women, depending on the trial.
Trial overview
These studies are all looking at Sildenafil in different patient groups and for different goals.
The trial set includes interventional studies, which means the researchers give one treatment or another and then compare the results.
The study phases range from Phase 1 to Phase 4, so the data include both early testing and later research.
Post-surgery rehabilitation studies
Two trials study recovery of sexual function after cancer surgery in men.
The PEHAB II study is in men after nerve-sparing radical prostatectomy, which is prostate surgery that tries to protect nerves linked to erections.
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.
The RECTIL trial studies men treated with proctectomy for rectal cancer, which means surgery to remove part or all of the rectum.
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.
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.
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.
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.
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.
Fontan operation study
One Phase 3 pilot study looks at adults with a functionally single ventricle after a Fontan operation.
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.
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.
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.
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.
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.
Researchers measured the difference in migraine-like attacks in men and compared migraine-like attacks in Sildenafil-treated men and women.
What the trials measure
The main outcomes in these studies are very different because each trial has a different goal.
- Erection recovery: two studies measure whether patients regain unassisted erections or reach a defined erectile function score after surgery.
- Brain MRI outcome: one newborn study checks survival without brain lesions on MRI at discharge.
- Drug levels in blood: one newborn study first measures plasma concentrations of Sildenafil.
- Exercise capacity: one heart study measures peak oxygen uptake after 24 weeks of treatment.
- Headache events: one migraine study measures how often migraine-like attacks occur after Sildenafil.