Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
72
Countries
1
Sites
1
Erectile dysfunction
Key facts
- Sponsor
- Dicot AB, Dicot AB
- Participant type
- Healthy volunteers
- Age range
- 18-64 years, 65+ years
- Gender
- Male
- Therapeutic area
- Diseases [C] - Male Urogenital Diseases [C12]
- Trial duration
- 25 Aug 2023 → 4 Apr 2024
- Decision date (initial)
- 2023-08-14
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Erectile dysfunction
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10061461 | Erectile dysfunction | 100000004872 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Dicot AB
- Sponsor organisation
- Dicot AB
- Address
- S:t Olofsgatan 11a, Uppsala Domkyrkofors. Uppsala Domkyrkofors.
- City
- Uppsala
- Postcode
- 753 21
- Country
- Sweden
Scientific contact point
- Organisation
- Dicot AB
- Contact name
- Charlotta Gauffin
Public contact point
- Organisation
- Dicot AB
- Contact name
- Elin Trampe
Dicot AB
- Sponsor organisation
- Dicot AB
- Address
- S:t Olofsgatan 11a, Uppsala Domkyrkofors Uppsala Domkyrkofors
- City
- Uppsala
- Postcode
- 753 21
- Country
- Sweden
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Sweden | Ended | 72 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
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 |
|---|---|---|---|---|---|
| Sweden | 2023-08-25 | 2024-04-04 | 2023-08-25 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-05-31 | Sweden | Acceptable with conditions 2023-08-14
|
2023-08-14 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-08-24 | Sweden | Acceptable 2023-10-05
|
2023-10-05 |