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Sildenafil Citrate

Clinical trials investigating Sildenafil Citrate are studying different patient groups to see how well it works and how safe it is in real-world and research settings. The trials include people with erectile dysfunction, peripheral arterial disease, hypothyroidism with erectile problems, and systemic sclerosis with digital ulcers.

Table of contents

Overview of the trials

The source data includes four interventional studies of Sildenafil Citrate or a Sildenafil product in different patient groups.[1][2][3][4]

These studies are designed to answer practical research questions such as whether the treatment is safe, whether it improves symptoms, and whether patients can use it safely and independently.[1][3][4]

Conditions studied

One study looks at digital ulcers in systemic sclerosis, which are painful sores on the fingers in a disease that affects the skin and blood vessels.[1]

Another study examines peripheral arterial disease with intermittent claudication, a condition where people have leg pain when walking because blood flow to the legs is reduced.[2]

Two studies focus on erectile dysfunction, including one in people with subclinical hypothyroidism, which means thyroid hormone levels are not clearly normal but not severely low.[3][4]

Trial phases and study design

The safety study in systemic sclerosis is a Phase 1/2 interventional trial with 15 participants and is authorised.[1]

The other three studies are Phase 3 trials, which usually involve larger groups and are used to confirm benefit and collect more data on outcomes.[2][3][4]

The peripheral arterial disease study is a national, multicenter, prospective, randomized, double-blind, placebo-controlled trial.[2] This means it was run at several centers, followed people over time, assigned treatment by chance, and compared Sildenafil Citrate with a placebo.[2]

The hypothyroidism study compares three study groups and follows participants from baseline to a 3-month post-treatment follow-up.[3]

The study on independent use of Sildenafil 100 mg checks whether participants can make a safe decision on their own about using the treatment with a dedicated diagnostic tool.[4]

What the trials measure

The systemic sclerosis study measures local treatment-emergent adverse events, which are health problems that appear after treatment starts, and also measures pain at the ulcer using a numeric rating scale from 0 to 10.[1]

The peripheral arterial disease study measures the change in absolute claudication distance, which is the distance a person can walk on a treadmill before leg pain stops them from continuing.[2]

The hypothyroidism study measures changes in questionnaire scores, including IIEF-15, EHS, PGIC, and EDITS, to track erectile function, hardness, overall change, and treatment satisfaction.[3]

The independent-use study has a non-public primary outcome, but its summary states that the main goal is to see whether people can safely decide if Sildenafil 100 mg is appropriate for them.[4]

Who can participate

Each trial focuses on a different patient group, so participation depends on the condition being studied.[1][2][3][4]

  • The authorised Phase 1/2 study includes patients with systemic sclerosis and active digital ulcers on the fingertips.[1]
  • The Phase 3 walking study includes patients with peripheral arterial disease and intermittent claudication.[2]
  • The thyroid study includes patients with subclinical hypothyroidism and erectile dysfunction.[3]
  • The self-use study includes patients with erectile dysfunction who are being assessed with a dedicated diagnostic tool.[4]

Key trial details

The safety and tolerability study tests TOP-N53 on wounds in a hydrogel form and includes a vehicle comparison, with dose escalation over 3 hours and, for the highest dose, 24 hours of exposure.[1]

The walking-distance study uses oral Sildenafil Citrate at 140 mg and compares it with microcrystalline cellulose, the placebo used in the trial.[2]

The thyroid study uses oral Sildenafil and oral levothyroxine sodium, and it evaluates changes over time in sexual-function questionnaires.[3]

The independent-use study uses a 100 mg oral Sildenafil product and focuses on safe self-selection for use in erectile dysfunction.[4]

Trial ID Phase Condition studied Status Enrollment
NCT06954597 Phase 1/2 Digital ulcers in systemic sclerosis Authorised 15
NCT03686306 Phase 3 Peripheral arterial disease Completed 220
2024-514789-38-00 Phase 3 erectile function, hypothyroidism subclinic Completed 90
2025-522923-81-00 Phase 3 Erectile dysfunction Completed 200

FAQ

  • Who can join clinical trials of Sildenafil Citrate? It depends on the study. The trials in the source data include adults with erectile dysfunction, peripheral arterial disease with intermittent claudication, subclinical hypothyroidism with erectile dysfunction, and patients with systemic sclerosis and digital ulcers.
  • What are these trials trying to find out? They study different goals, such as safety, tolerability, walking ability, sexual function, and whether patients can use Sildenafil Citrate safely on their own. Some trials also compare Sildenafil Citrate with placebo, which is a look-alike treatment with no active medicine.
  • What phases are represented in the trials? The source data includes Phase 1/2 and Phase 3 studies. Early-phase trials focus more on safety and tolerability, while Phase 3 trials usually look at how well the treatment works in larger groups.
  • What conditions are being studied? The trials study digital ulcers in systemic sclerosis, peripheral arterial disease with intermittent claudication, erectile dysfunction, and erectile dysfunction linked with subclinical hypothyroidism. Each study targets a different medical need.
  • What kinds of results are measured in these trials? The trials measure outcomes such as pain scores, adverse events, walking distance on a treadmill, and questionnaire scores about erectile function and treatment satisfaction. These results help researchers judge benefit and safety.

Sperimentazioni cliniche in corso su Sildenafil Citrate

  • Studio sulla sicurezza e tollerabilità di TOP-N53 per ulcere digitali in pazienti con sclerosi sistemica

    In arruolamento

    1 1
    Malattie in studio:
    Farmaci in studio:
    Francia

  • Studio sulla capacità dei pazienti con disfunzione erettile di utilizzare in modo sicuro e indipendente il sildenafil 100 mg

    Arruolamento concluso

    1 1 1 1
    Malattie in studio:
    Farmaci in studio:
    Polonia

  • Studio sull’impatto della levotiroxina e del sildenafil sulla funzione erettile nei pazienti con ipotiroidismo subclinico

    Arruolamento concluso

    1 1 1 1
    Malattie in studio:
    Farmaci in studio:
    Spagna

  • Studio sull’efficacia del sildenafil per migliorare la capacità di camminare in pazienti con arteriopatia periferica e claudicatio intermittente

    Arruolamento concluso

    1 1 1
    Farmaci in studio:
    Francia

Glossario

  • Clinical trial: A research study in people that tests whether a treatment is safe, works well, or both.
  • Interventional study: A study where researchers give a treatment or compare treatments to see what happens.
  • Phase 1/2: An early study phase that looks first at safety and tolerability, and may also begin to look at whether the treatment helps.
  • Phase 3: A later study phase usually done in larger groups to confirm how well a treatment works and to collect more safety data.
  • Placebo: A look-alike treatment with no active medicine, used for comparison in some studies.
  • Adverse event: A health problem that happens during a study, whether or not it is caused by the treatment.
  • Tolerability: How well people can take or use a treatment without too much discomfort or trouble.
  • Digital ulcer: An open sore on a finger or toe, often painful and slow to heal.
  • Systemic sclerosis: A long-term disease that can affect the skin and blood vessels and may cause ulcers on the fingers.
  • Intermittent claudication: Pain in the legs that comes on with walking and improves with rest.
  • Questionnaire score: A number based on answers to questions, used to measure symptoms or treatment effect.
  • Erectile function: How well a person can get and keep an erection.

Riferimenti

  1. https://studi-clinici.it/studio/studio-sulla-sicurezza-e-tollerabilita-di-top-n53-per-ulcere-digitali-in-pazienti-con-sclerosi-sistemica/
  2. https://studi-clinici.it/studio/studio-sullefficienza-del-sildenafil-nei-pazienti-con-malattia-arteriosa-periferica-e-claudicatio-intermittente/
  3. https://clinicaltrials.gov/study/2024-514789-38-00
  4. https://clinicaltrials.gov/study/2025-522923-81-00