Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ended
Participants planned
200
Countries
1
Sites
8
Erectile dysfunction
The primary objective of the study is to assess whether participants using dedicated diagnostic tool can independently make safe decision whether it is appropriate for them to use or not use sildenafil in dose of 100 mg.
Key facts
- Sponsor
- Zaklady Farmaceutyczne Polpharma S.a.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male
- Therapeutic area
- Diseases [C] - Male Urogenital Diseases [C12]
- Trial duration
- 17 Feb 2026 → 14 Apr 2026
- Decision date (initial)
- 2026-01-26
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Pharmaceutical Works POLPHARMA S.A./Zakłady Farmaceutyczne Polpharma S.A.
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Others
The primary objective of the study is to assess whether participants using dedicated diagnostic tool can independently make safe decision whether it is appropriate for them to use or not use sildenafil in dose of 100 mg.
Secondary objectives 5
- Assessment whether participant’s using dedicated diagnostic tool can independently make safe decision whether it is appropriate for them to use or not use sildenafil in in any dose.
- Assessment of coherence of participant’s and Investigator’s decision on the possibility of taking sildenafil in 100 mg dose.
- Assessment of usefulness of diagnostic tool in the decision making process concerning administration of sildenafil 100 mg and in any dose.
- Assessment of coherence of answers given by participation question concerning specific health issues included in the diagnostic tool, with the findings implied by results of cardiological/laboratory assessments.
- In regards to participants who receive IMP: Compliance - whether participant used the medication as prescribed; Efficacy - the participant’s assessment of efficacy of used medication (whether its administration allowed for achieving and maintaining a penile erection sufficient for efficient sexual intercourse); Safety - whether and what adverse drug reactions occurred after administration of sildenafil 100 mg.
Conditions and MedDRA coding
Erectile dysfunction
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10061461 | Erectile dysfunction | 100000004872 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- Males aged 18 years* and older sexually active and planning to have sexual interactions.
- Signed informed consent to participate in the study prior to commencing study procedures.
- Participants able to understand and follow study procedures.
Exclusion criteria 4
- Lack of reading and writing skills or comprehension in Polish.
- Symptoms of active infection.
- Severe physical or mental disease that might hamper the realization of the trial according to the protocol.
- Unreliability or lack of cooperation
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Not for public
Secondary endpoints 2
- 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
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
MAXIGRA, 100 mg, tabletki powlekane
PRD12662632 · Product
- Active substance
- Sildenafil Citrate
- Substance synonyms
- Sildenafil dihydrogen citrate
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 100 mg milligram(s)
- Max total dose
- 100 mg milligram(s)
- Max treatment duration
- 42 Day(s)
- Authorisation status
- Authorised
- ATC code
- G04BE03 — SILDENAFIL
- Marketing authorisation
- 10310
- MA holder
- ZAKLADY FARMACEUTYCZNE POLPHARMA S.A.
- MA country
- Poland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Zaklady Farmaceutyczne Polpharma S.a.
- Sponsor organisation
- ZAKLADY FARMACEUTYCZNE POLPHARMA S.A.
- Address
- Ul. Pelplinska 19
- City
- Starogard Gdanski
- Postcode
- 83-200
- Country
- Poland
Scientific contact point
- Organisation
- ZAKLADY FARMACEUTYCZNE POLPHARMA S.A.
- Contact name
- Medical Monitor
Public contact point
- Organisation
- ZAKLADY FARMACEUTYCZNE POLPHARMA S.A.
- Contact name
- Medical Monitor
Third parties 3
| Organisation | City, country | Duties |
|---|---|---|
| Cleandatalabs Sp. z o.o. ORG-100048217
|
Warsaw, Poland | Code 10, Interactive response technologies (IRT), Data management |
| Scientia CRO Sp. z o.o. ORG-100047739
|
Bydgoszcz, Poland | On site monitoring, Code 10, Code 11, Code 12, Code 2, Code 5, Code 8 |
| SoftBlue SA ORL-000016035
|
Bydgoszcz, Poland | E-data capture |
Locations
1 EU/EEA country · 8 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Poland | Ended | 200 | 8 |
| Rest of world | — | 0 | — |
Investigational sites
NZOZ Awicenna Plac 1-Maja 9
Poradnia Urologiczna, Plac 1-Maja 9, 89-115, Mrocza
4 Wojskowy Szpital Kliniczny Z Poliklinika Samodzielny Publiczny Zaklad Opieki Zdrowotnej We Wroclawiu
Kliniczny Oddział Urologii, Ul. Rudolfa Weigla 5, 53-114, Wroclaw
Medsearch Institute
N/A, Dworcowa 8, 88-181, Jaksice
Omega Medical Clinics Sp. Z o.o.
N/A, Księdza Zygmunta Trybowskiego 14, 85-796, Bydgoszcz
Menvita - Klinika Andrologii i Zdrowia Seksualnego
N/A, Jurajska 3/U4, 02-699, Warszawa
Garbary Clinic Sp z o.o.
Gabinet Urologiczny, Garbary 5/LU3, 85-229, Bydgoszcz
SPZOZ w Chełmnie
Poradnia Urologiczna, Plac Rydygiera 1, 86-200, Chełmno
FARMA -MED. Kujawskie Centrum Medyczne Spółka z o.o.;
Poradnia Urlogiczna, Narutowicza 24, 88-100, Inowrocław
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Poland | 2026-02-17 | 2026-02-17 | 2026-04-14 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 13 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol signature page_2025-522923-81_redacted | 3.0 |
| Protocol (for publication) | D1_Protocol_2025-522923-81_redacted | 3.0 |
| Protocol (for publication) | D4_Patient facing documents questionnaire IIEF-5_placeholder | 1 |
| Protocol (for publication) | D4_Patient facing documents_Informator dla Pacjenta_placeholder | 1.0 |
| Protocol (for publication) | D4_Patient facing documents_Participant diary | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material description_leaflet-poster | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF description_interventional group_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF description_observational group_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material description_Participant s card | 1.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Maxigra 100mg | N/A |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis EN_2025-522923-81_redacted | 3.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis PL_2025-522923-81_redacted | 3.0 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-09-30 | Poland | Acceptable 2026-01-23
|
2026-01-26 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2026-02-03 | Poland | Acceptable 2026-03-16
|
2026-03-23 |