Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruiting
Participants planned
108
Countries
1
Sites
2
Hysterectomy
Key facts
- Sponsor
- CHU De Rouen
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Female
- Therapeutic area
- Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]
- Trial duration
- 19 Apr 2024 → ongoing
- Decision date (initial)
- 2023-10-24
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2023-504926-20-00
- ClinicalTrials.gov
- NCT05969457
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Hysterectomy
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
CHU De Rouen
- Sponsor organisation
- CHU De Rouen
- Address
- 1 Rue De Germont, Bp 96031 Bp 96031
- City
- Rouen Cedex
- Postcode
- 76031
- Country
- France
Scientific contact point
- Organisation
- CHU De Rouen
- Contact name
- Patrice CROCHET
Public contact point
- Organisation
- CHU De Rouen
- Contact name
- David Mallet
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 108 | 2 |
| Rest of world | — | 0 | — |
Investigational sites
CHU De Rouen
gynecologic-obstetrical department, 1 Rue De Germont, Bp 96031, Rouen Cedex
Groupe Hospitalier Du Havre
gynecologic-obstetrical department, 55 B Rue Gustave Flaubert, Bp 24, Le Havre Cedex
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 |
|---|---|---|---|---|---|
| France | 2024-04-19 | 2025-09-16 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-07-18 | France | Acceptable 2023-10-23
|
2023-10-24 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-06-14 | France | Acceptable 2024-07-08
|
2024-07-30 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-04-07 | France | Acceptable 2024-07-08
|
2025-04-07 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-05-16 | France | Acceptable 2025-06-25
|
2025-06-26 |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2026-01-13 | France | Acceptable 2026-03-02
|
2026-03-27 |