In breve
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.
Punti chiave
- Clinical trials investigating Sildenafil Citrate are looking at several different health problems, not just one condition. The studies in the source data include digital ulcers in systemic sclerosis, peripheral arterial disease with walking pain, erectile dysfunction, and erectile dysfunction linked with subclinical hypothyroidism. The trial phases range from early Phase 1/2 work focused on safety and tolerability to Phase 3 studies with larger groups. Some trials compare Sildenafil Citrate with placebo, while others assess patient-reported outcomes, walking distance, pain, and treatment satisfaction. The target populations are adults with the specific conditions listed in each study.
Overview of the trials
The source data includes four interventional studies of Sildenafil Citrate or a Sildenafil product in different patient groups.
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.
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.
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.
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.
Trial phases and study design
The safety study in systemic sclerosis is a Phase 1/2 interventional trial with 15 participants and is authorised.
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.
The peripheral arterial disease study is a national, multicenter, prospective, randomized, double-blind, placebo-controlled trial. This means it was run at several centers, followed people over time, assigned treatment by chance, and compared Sildenafil Citrate with a placebo.
The hypothyroidism study compares three study groups and follows participants from baseline to a 3-month post-treatment follow-up.
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.
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.
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.
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.
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.
Who can participate
Each trial focuses on a different patient group, so participation depends on the condition being studied.
- The authorised Phase 1/2 study includes patients with systemic sclerosis and active digital ulcers on the fingertips.
- The Phase 3 walking study includes patients with peripheral arterial disease and intermittent claudication.
- The thyroid study includes patients with subclinical hypothyroidism and erectile dysfunction.
- The self-use study includes patients with erectile dysfunction who are being assessed with a dedicated diagnostic tool.
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.
The walking-distance study uses oral Sildenafil Citrate at 140 mg and compares it with microcrystalline cellulose, the placebo used in the trial.
The thyroid study uses oral Sildenafil and oral levothyroxine sodium, and it evaluates changes over time in sexual-function questionnaires.
The independent-use study uses a 100 mg oral Sildenafil product and focuses on safe self-selection for use in erectile dysfunction.