Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Authorised, recruitment pending
Participants planned
70
Countries
1
Sites
1
Transsexual
Key facts
- Sponsor
- Karolinska University Hospital
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male
- Therapeutic area
- Diseases [C] - Hormonal diseases [C19], Psychiatry and Psychology [F] - Mental Disorders [F03]
- Decision date (initial)
- 2024-10-01
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-517052-35-00
- EudraCT number
- 2019-004349-34
- ClinicalTrials.gov
- NCT05649605
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Transsexual
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 24.1 | LLT | 10086080 | Female to male gender reassignment therapy | 100000004848 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Karolinska University Hospital
- Sponsor organisation
- Karolinska University Hospital
- Address
- Halsovagen, Flemingsberg Flemingsberg
- City
- Huddinge
- Postcode
- 141 86
- Country
- Sweden
Scientific contact point
- Organisation
- Karolinska University Hospital
- Contact name
- Mats Holmberg
Public contact point
- Organisation
- Karolinska University Hospital
- Contact name
- Mats Holmberg
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Sweden | Authorised, recruitment pending | 70 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-04 | Sweden | Acceptable with conditions 2024-10-01
|
2024-10-01 |