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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.

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-522923-81-00
Acronym
844700336/0156/1
Enrollment
200
Registered
2026-01-26
Start date
Unknown
Completion date
Unknown
Last updated
2026-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Erectile dysfunction

Brief summary

Not for public

Detailed description

Not for public, In regards to participants who receive IMP: ▪ Compliance - proportion of participants taking sildenafil as prescribed ▪ Efficacy - proportion of participants who report efficacy of used medication (whether administration of an IMP allowed for achieving and maintaining a penile erection sufficient for efficient sexual intercourse). ▪ Efficacy - proportion of satisfying sexual intercourses after administration sildenafil 100 mg (assessed per participant and per study population). ▪ Safety – number

Interventions

DRUGMAXIGRA
DRUG100 mg
DRUGtabletki powlekane

Sponsors

ZAKLADY FARMACEUTYCZNE POLPHARMA S.A.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
Male
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Not for public—

Secondary

MeasureTime frame
Not for public, In regards to participants who receive IMP: ▪ Compliance - proportion of participants taking sildenafil as prescribed ▪ Efficacy - proportion of participants who report efficacy of used medication (whether administration of an IMP allowed for achieving and maintaining a penile erection sufficient for efficient sexual intercourse). ▪ Efficacy - proportion of satisfying sexual intercourses after administration sildenafil 100 mg (assessed per participant and per study population). ▪ Safety – number—

Countries

Poland

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026