In short
Clinical trials investigating "Sildenafil Citrate" are studying how well it works and how safe it is in different patient groups. The trials include people with peripheral arterial disease, erectile dysfunction, subclinical hypothyroidism, and systemic sclerosis with digital ulcers. They measure outcomes such as walking distance, sexual function scores, safety, and patient-reported pain.
Key points
- Clinical trials of "Sildenafil Citrate" in this set focus on different patient groups, including people with peripheral arterial disease, erectile dysfunction, subclinical hypothyroidism, and digital ulcers from systemic sclerosis. The studies range from early Phase 1/2 research to Phase 3 trials. They measure outcomes such as walking ability, sexual function scores, treatment satisfaction, pain, and local safety. Some trials compare Sildenafil Citrate with placebo or other study treatments, while others look at how patients can safely decide whether to use it. The trial sizes are small to moderate, with enrollment from 15 to 220 participants.
Trial overview
The trial set includes four interventional studies of Sildenafil Citrate, with one study in Phase 1/2 and three studies in Phase 3.
The studies are authorised or completed and include small to moderate groups, from 15 participants up to 220 participants.
Conditions studied
One trial studies digital ulcers in people with systemic sclerosis, which is a long-term disease that can affect the skin and blood vessels.
Another trial studies peripheral arterial disease in people with intermittent claudication, meaning leg pain that comes on with walking.
Two studies focus on erectile dysfunction, including one in people with subclinical hypothyroidism and one multicenter study of patient ability to use Sildenafil 100 mg safely on their own.
What the trials measure
The Phase 1/2 study in systemic sclerosis looks at local treatment emergent adverse events, which are unwanted effects seen where the treatment is applied, and at pain reported by the patient using a numeric rating scale from 0 to 10.
The Phase 3 study in peripheral arterial disease measures the change in absolute claudication distance, the farthest distance a person can walk on a treadmill before leg pain stops them.
The thyroid and erectile dysfunction study measures changes in questionnaire scores, including IIEF-15, EHS, PGIC, and EDITS, from baseline to three months after treatment.
The multicenter study in erectile dysfunction mainly checks whether people can use a diagnostic tool to decide safely if Sildenafil 100 mg is appropriate for them; the detailed primary outcome is not public.
Trial phases and study designs
The systemic sclerosis study is a Phase 1/2 interventional study with escalating dose levels of a topical investigational product on wounds, and it also includes oral Sildenafil Teva as part of the study details.
The peripheral arterial disease study is a Phase 3, national, multicenter, prospective, randomized, double-blind, placebo-controlled trial.
The hypothyroidism and erectile dysfunction study is a Phase 3 interventional study that compares study groups over time and follows patients for three months after treatment starts.
The multicenter erectile dysfunction study is also a Phase 3 interventional study focused on safe independent use of Sildenafil 100 mg.
Who may be included
The studies are built for different groups of patients, so eligibility depends on the condition being studied.
- People with systemic sclerosis and digital ulcers may be included in the wound safety study.
- People with peripheral arterial disease and intermittent claudication may be included in the walking-distance study.
- People with subclinical hypothyroidism and erectile dysfunction may be included in the hormone and sexual function study.
- People with erectile dysfunction may be included in the self-use safety study of Sildenafil 100 mg.
Patient-relevant points
These trials do not study the same problem, so the main goal changes from one study to another.
Some studies focus on safety, such as local skin tolerability and treatment-emergent adverse events, while others focus on benefit, such as walking farther or improving sexual function scores.
The trial names also show that study design matters: one study is placebo-controlled and double-blind, which means neither the participant nor the researcher knows who gets the active treatment during the study period.
Overall, the research program looks at safety, tolerability, and effectiveness in specific patient groups rather than one single disease area.