A multicenter, prospective clinical TRrial evaluating patient’s ability to make an independent and safe decision regarding the USe of the medicinal product Sildenafil Polpharma100 mg indicated in the Treatment of erectile dysfunction. TRUST Trial on Responsible Use and Self-assessed Treatment.

The primary objective of this study is to assess whether participants using a dedicated diagnostic tool can independently make a safe decision regarding the appropriateness of using sildenafil in a dose of 100 mg for the treatment of erectile dysfunction. This evaluation is clinically relevant for determining the feasibility of patient self-assessment in the context of transitioning sildenafil from prescription-only to over-the-counter availability, ensuring that patients can identify contraindications and make informed decisions without direct physician oversight.

The secondary objectives include:

• Assessment of whether participants using the dedicated diagnostic tool can independently make a safe decision regarding the appropriateness of using sildenafil in any dose.
• Evaluation of the concordance between participant and investigator decisions regarding the appropriateness of sildenafil 100 mg administration.
• Assessment of the usefulness of the diagnostic tool in the decision-making process concerning administration of sildenafil 100 mg and in any dose.
• Evaluation of the concordance between participant responses to questions concerning specific health issues included in the diagnostic tool and findings from cardiological and laboratory assessments.
• For participants receiving the investigational medicinal product: assessment of compliance with prescribed medication use, evaluation of participant-reported efficacy in achieving and maintaining penile erection sufficient for satisfactory sexual intercourse, and documentation of adverse drug reactions following sildenafil 100 mg administration.

The sponsor did not provide information regarding the total number of participants enrolled in this clinical trial. The study population consisted exclusively of **male participants** aged **18 years and older** who were **sexually active** and planning to have sexual interactions. The trial focused on individuals with **erectile dysfunction**. Participants were required to be capable of understanding and following study procedures and to provide signed informed consent prior to commencing any study-related activities. No vulnerable populations were included in this trial. The study aimed to assess whether participants could independently make safe decisions regarding the use of **sildenafil** at a dose of 100 mg through a dedicated diagnostic tool.

This is a multicenter, prospective clinical trial designed to evaluate the ability of participants to independently and safely use sildenafil 100 mg for the treatment of erectile dysfunction. The study is classified as a Phase IV trial and involves the use of MAXIGRA 100 mg film-coated tablets containing sildenafil citrate as the active substance, administered via the oral route. The primary objective is to assess whether participants, using a dedicated diagnostic tool, can independently make safe decisions regarding the appropriateness of using sildenafil at a dose of 100 mg. The trial will evaluate compliance, efficacy in achieving and maintaining penile erection sufficient for sexual intercourse, the proportion of satisfying sexual encounters following administration, and safety outcomes. The maximum daily dose is 100 mg, with a maximum total dose of 100 mg and a maximum treatment period of 42 days.

The trial is expected to commence recruitment in February 2026 and conclude by June 2026, resulting in an overall trial duration of approximately five months. Participant involvement will extend throughout the treatment period of up to 42 days, with additional time allocated for screening and follow-up assessments. The study population will consist of males aged 18 years and older who are sexually active and planning sexual interactions. Principal inclusion criteria require that participants provide signed informed consent prior to commencing study procedures and demonstrate the ability to understand and follow study protocols.

The study will include a screening visit to assess eligibility, followed by treatment visits during which participants will receive the investigational medicinal product and undergo evaluation. Follow-up visits will be conducted to monitor compliance, efficacy, and safety throughout the treatment period. An end-of-study visit will be performed to complete final assessments and document outcomes. Conditions that may lead to early termination from the study include non-compliance with study procedures, adverse events requiring discontinuation, withdrawal of consent, or investigator decision based on participant safety considerations.

The experimental medication evaluated in this clinical trial is **MAXIGRA**, containing **sildenafil citrate** as the active pharmaceutical ingredient. The product is formulated as **film-coated tablets** with a strength of **100 mg**. The **route of administration** is **oral**. The **maximum daily dose** is 100 mg, with a **maximum total dose** of 100 mg per administration. The **maximum treatment period** is 42 days. Sildenafil citrate, also known by its chemical synonym sildenafil dihydrogen citrate, is a chemical substance classified under **ATC code G04BE03** and is indicated for the **treatment of erectile dysfunction**. The medicinal product is manufactured by Zaklady Farmaceutyczne Polpharma S.A. and holds marketing authorization number 10310 in Poland.

The study design focuses on evaluating participants' ability to make independent and safe decisions regarding the use of sildenafil 100 mg through a dedicated diagnostic tool. The trial involves participant self-assessment to determine the appropriateness of medication use. **Compliance monitoring** is integrated into the study design through the evaluation of participants' decision-making capacity using the designated diagnostic instrument. The study protocol emphasizes the assessment of whether participants can safely and independently decide on the use or non-use of the investigational medicinal product based on their individual clinical circumstances.

Efficacy will be assessed through the evaluation of the proportion of participants who report efficacy of the used medication, specifically whether administration of sildenafil allows for achieving and maintaining a **penile erection** sufficient for efficient sexual intercourse. Additionally, the proportion of satisfying sexual intercourses after administration of **sildenafil** 100 mg will be measured, with assessments conducted per participant and per study population. These efficacy parameters are designated as secondary endpoints in the clinical trial evaluating the use of sildenafil in the treatment of **erectile dysfunction**.