Clinical trials: Sildenafil, open to volunteers
Pulmonary Arterial Hypertension (PAH)
Randomized Study of Triple Therapy vs Sildenafil Dose Optimization in Pulmonary Arterial Hypertension
Pulmonary arterial hypertension (PAH) is a rare and progressive disease characterized by increased pressure in the pulmonary arteries, leading to right heart failure and premature death.
- Trial name
- ASCEND-PAH (NCT07713914)
- Testing
- Prostacyclin Pathway Agent, Sildenafil Dose Optimization
- Where
- Brazil
- Volunteers
- 196 people
- Sponsor
- University of Sao Paulo General Hospital
Erectile Dysfunction
Effect of Moderate Alcohol on Absorption and Onset of Hezkue Sildenafil Suspension
This is a Phase 2, open-label, randomized crossover study assessing the effect of moderate alcohol intake on the absorption and onset of action of Hezkue® sildenafil oral suspension in adult subjects.
- Trial name
- NCT07290400
- Testing
- Hezkue Sildenafil Oral Suspension, Moderate Alcohol Intake
- Volunteers
- 36 people
- Sponsor
- Aspargo Labs, Inc
Premature Ejaculation
Therapeutic Outcomes of Selective Serotonin Reuptake Inhibitors and Phosphodiesterase-5 Inhibitors Combination Therapy Versus Monotherapy
Premature ejaculation (PE) is a prevalent male sexual dysfunction that affects as many as 20-30% of men regardless of age and ethnicity.The International Society for Sexual Medicine defines premature ejaculation as a male sexual…
- Trial name
- NCT07057011
- Testing
- Paroxetine 20 Mg Oral Tablet
- Where
- Egypt
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- South Valley University
Erectile Dysfunction Following Radical Prostatectomy
PEnile ReHABilitation After Nerve Sparing Robot-assisted Radical Prostatectomy for Prostate Cancer 2.0 (PEHAB-II)
The PEHAB-II study is prospective, randomized trial designed to assess the effect of two different rehabilitation strategies on the recovery of erectile function in nerve sparing prostatectomy patients.
- Trial name
- PEHAB-II (NCT06875258)
- Testing
- Sildenafil, Erectile vacuum device
- Where
- 3 sites in Netherlands
- Volunteers
- 198 people
- Sponsor
- The Netherlands Cancer Institute
Erectile Dysfunction
Phase 2 Efficacy Study of Sildenafil Products in Adult Men With Erectile Dysfunction
The goal of this clinical trial is to learn how different sildenafil-based erectile dysfunction (ED) treatments affect erectile function in adult men.
- Trial name
- NCT07231185
- Testing
- Hezkue, Hezkue Turbo, Galotam
- Volunteers
- 200 people
- Sponsor
- Aspargo Labs, Inc
Pulmonary Arterial Hypertension
Initial Triple Therapy Including Parenteral Treprostinil vs Initial Double Oral Therapy in PAH Group I Patients
TripleTRE investigates the effect of initial triple combination therapy (oral endothelin receptor antagonist (ERA) + oral phosphodiesterase tyüe-5 inhibitor (PDE-5i) + parenteral treprostinil) compared to double oral therapy…
- Trial name
- TripleTRE (NCT06317805)
- Testing
- Generic treprostinil sodium + Standard of Care (Double Oral), Standard of Care - Double Oral
- Where
- 28 sites in Argentina, Austria and 10 more
- Volunteers
- 110 people
- Sponsor
- AOP Orphan Pharmaceuticals AG
Healthy Volunteers
PK and Onset of Hezkue Oral Sildenafil Suspension After Alcohol Consumption
This is an open-label, randomized study evaluating the pharmacokinetics and onset performance of Hezkue® oral sildenafil suspension administered following moderate alcohol consumption in healthy adult subjects.
- Trial name
- NCT07302698
- Testing
- Hezkue Oral Sildenafil Suspension
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Aspargo Labs, Inc
Persistent Pulmonary Hypertension of Newborn
Nebulized Magnesium Sulfate and Sildenafil for Persistent Pulmonary Hypertension of Newborn
The aim of this study is to evaluate the effectiveness of nebulized magnesium sulfate combined with sildenafil citrate, compared with sildenafil citrate alone, in treating neonates with severe persistent pulmonary hypertension on…
- Trial name
- NCT04898114
- Testing
- Magnesium sulfate, Sildenafil Citrate, Isotonic saline
- Where
- Egypt
- Volunteers
- 40 people
- Sponsor
- Sohag University
Fontan Circulation
IMProving DRug Dosing and Outcomes for Single VEntricle Patients With Fontan Associated Liver Disease
This is a single center, open-label, prospective, investigation to quantify the effects liver congestion and fibrosis has on hepatic drug metabolism and transport in children, adolescents, and young adults with Fontan circulation.
- Trial name
- IMPROVE-FALD (NCT06324396)
- Testing
- Sildenafil 10mg oral tablet (participants <20kg), or 20mg oral tablet (participants ≥20kg), Pravastatin 20 mg oral tablet (ages <13 years), or 40 mg oral tablet (≥14 years)
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Children's Mercy Hospital Kansas City
Erectile Dysfunction
The Objective of This Phase 1 Study is to Evaluate the Food Effect of 100 mg Hezkue Turbo® (ASP-001.1, Sildenafil) Under Fed Versus 100 mg of Hezkue Turbo® (ASP-001.1, Sildenafil) Under Fasted Conditions in Healthy Adult Male Subjects
The objective of this phase 1 study is to evaluate the food effect of 100 mg Hezkue Turbo® (ASP-001.1, sildenafil) under fed versus 100 mg of Hezkue Turbo® (ASP-001.1, sildenafil) under fasted conditions in healthy adult male…
- Trial name
- NCT06872866
- Testing
- ASP-001.1
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Aspargo Labs, Inc
Chronic Thromboembolic Pulmonary Hypertension
Switching of Sildenafil to Riociguat in CTEPH Patients
This study was designed to investigate the safety and efficacy of replacing phosphodiesterase 5 inhibitors (PDE5i) with riociguat in patients with Chronic thromboembolic pulmonary hypertension (CTEPH) who have undergone pulmonary…
- Trial name
- S2R (NCT06715280)
- Testing
- Riociguat (Adempas)
- Where
- Hong Kong
- Volunteers
- 30 people
- Sponsor
- Chinese University of Hong Kong
Erectile Dysfunction (ED), Erectile Dysfunctions
A Single-Arm, Dose Escalation of an Intraurethral Alprostadil Paste for Erectile Dysfunction
This is a single arm dose escalation trial of a mucoadhesive intraurethral polymer suspension of alprostadil (ST-04) and will investigate the efficacy of 3 dose levels of ST-04 in adult males with a clinical diagnosis of Erectile…
- Conditions
- Erectile Dysfunction (ED), Erectile Dysfunctions, Erectile Function
- Trial name
- NCT07601646
- Testing
- ST-04
- Where
- Canada
- Volunteers
- 83 people
- Sponsor
- Ryan Flannigan, MD
Hypoxic-Ischemic Encephalopathy
Sildenafil Plus Hypothermia to Treat Neonatal Encephalopathy
The main objective of this study is to assess pharmacokinetics features of IV sildenafil in neonates with hypoxic-ischemic encephalopathy and treated by controlled hypothermia.
- Trial name
- SHINE1 (NCT06810284)
- Testing
- Sildenafil Citrate (IV)
- Where
- France
- Volunteers
- 24 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Rectal Cancer
Interest of Early Erectile Rehabilitation With Sildenafil After Radiotherapy and Proctectomy for Rectal Cancer
This study aims to evaluate the efficacy of erectile rehabilitation with Sildenafil, in men treated with neoadjuvant proctectomy and radiotherapy for rectal cancer, in preventing long-term erectile dysfunction at 12 months…
- Trial name
- RECTIL (NCT06123156)
- Testing
- Sildenafil
- Where
- 14 sites in France
- Volunteers
- 188 people
- Sponsor
- University Hospital, Rouen
Brain Tumor
Asciminib With or Without Sildenafil for Brain Tumors
Dissemination of medulloblastoma is an independent risk factor of poor prognosis. Dissemination of medulloblastoma at recurrence is nearly universally fatal.
- Trial name
- NCT07039760
- Testing
- Asciminib, Sildenafil, Surgical resection or biopsy
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Washington University School of Medicine
Erectile Dysfunction
Combination Therapy of Tadalafil 2.5mg Plus Sildenafil 25mg Versus Tadalafil 5 mg Monotherapy for Treatment of Erectile Dysfunction: A Randomized, Placebo-Controlled Double-Blinded Cross-Over Study
Erectile dysfunction (ED) is characterized by the persistent inability to attain or sustain an erection adequate for satisfactory sexual intercourse.
- Trial name
- NCT07177326
- Testing
- Tadalafil 2.5 mg, Sildenafil 25 mg, Tadalafil 5 mg
- Volunteers
- 142 people
- Sponsor
- Assiut University
Cancer
Sildenafil to Prevent and Reduce Cancer Related Cognitive Impairment
This study is examining the effects of standard of care cancer treatment as well as a medication called Sildenafil, on the cancer associated fatigue, cognition and the gut microbiome.
- Trial name
- SPARC (NCT06800092)
- Testing
- Sildenafil
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- The University of Texas Medical Branch, Galveston
Traumatic Brain Injury
Sildenafil for Microvasculopathy in Chronic TBI
Traumatic Cerebral Vascular Injury (TCVI) is a common consequence of traumatic brain injury (TBI), including mild TBI (mTBI). TCVI is associated with poor recovery after TBI in animal models.
- Trial name
- CVR-TBI (NCT05782244)
- Testing
- Sildenafil Citrate low dose, Sildenafil medium dose, Sildenafil high dose
- Where
- United States
- Volunteers
- 160 people
- Sponsor
- University of Pennsylvania
Pulmonary Arterial Hypertension (PAH), Pulmonary Hypertension (PH)
COMPERA / COMPERA-KIDS
In view of the manifold options for mono- and combination therapy that have now emerged for patients with pulmonary (arterial) hypertension (PH/PAH), controlled clinical trials can only provide part of the information needed for…
- Trial name
- COMPERA (NCT01347216)
- Where
- 7 sites in Belgium, Germany and 2 more
- Volunteers
- 14,000 people
- Sponsor
- Technische Universität Dresden
Erectile Dysfunction
Hezkue®, Hezkue Turbo®, and Commercial Sildenafil Products in Fed Healthy Male Subject
The goal of this clinical trial is to compare how different sildenafil formulations are absorbed and tolerated in healthy adult males under fed conditions.
- Trial name
- NCT07117383
- Testing
- ASP-001.1, ASP-001, Commercial Sildenafil and Sildenafil/Tadalafil Products
- Where
- United States
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Aspargo Labs, Inc