Table of Contents
- Trial overview
- Conditions studied
- What the trials measure
- Trial phases and study designs
- Who may be included
- Patient-relevant points
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.[1][2][3][3]
The studies are authorised or completed and include small to moderate groups, from 15 participants up to 220 participants.[1][2][3][3]
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.[1]
Another trial studies peripheral arterial disease in people with intermittent claudication, meaning leg pain that comes on with walking.[2]
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.[3][3]
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.[1]
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.[2]
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.[3]
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.[3]
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.[1]
The peripheral arterial disease study is a Phase 3, national, multicenter, prospective, randomized, double-blind, placebo-controlled trial.[2]
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.[3]
The multicenter erectile dysfunction study is also a Phase 3 interventional study focused on safe independent use of Sildenafil 100 mg.[3]
Who may be included
The studies are built for different groups of patients, so eligibility depends on the condition being studied.[1][2][3][3]
People with systemic sclerosis and digital ulcers may be included in the wound safety study.[1]
People with peripheral arterial disease and intermittent claudication may be included in the walking-distance study.[2]
People with subclinical hypothyroidism and erectile dysfunction may be included in the hormone and sexual function study.[3]
People with erectile dysfunction may be included in the self-use safety study of Sildenafil 100 mg.[3]
Patient-relevant points
These trials do not study the same problem, so the main goal changes from one study to another.[1][2][3][3]
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.[1][2][3]
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.[2]
Overall, the research program looks at safety, tolerability, and effectiveness in specific patient groups rather than one single disease area.[1][2][3][3]
