Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
20
Countries
1
Sites
1
Polycystic ovarian
Key facts
- Sponsor
- Centre Hospitalier Universitaire De Lille
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Female
- Therapeutic area
- Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]
- Trial duration
- 17 Apr 2024 → 9 Feb 2025
- Decision date (initial)
- 2024-11-08
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-514102-32-00
- EudraCT number
- 2023-000176-35
- ClinicalTrials.gov
- NCT05751252
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Polycystic ovarian
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 27.0 | PT | 10065161 | Polycystic ovarian syndrome | 10038604 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Centre Hospitalier Universitaire De Lille
- Sponsor organisation
- Centre Hospitalier Universitaire De Lille
- Address
- 2 Avenue Oscar Lambret, Cs 70001 Cs 70001
- City
- Lille Cedex
- Postcode
- 59037
- Country
- France
Scientific contact point
- Organisation
- Centre Hospitalier Universitaire De Lille
- Contact name
- Pr Sophie CATTEAU JONARD
Public contact point
- Organisation
- Centre Hospitalier Universitaire De Lille
- Contact name
- Mrs. Brigitte COURTOIS
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 20 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Centre Hospitalier Universitaire De Lille
Service de Gynécologie Médicale, Avenue Eugene Avinee, 59037, Lille 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 | 2024-04-17 | 2025-02-09 | 2024-04-17 | 2025-02-09 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-27 | France | Acceptable 2024-11-08
|
2024-11-08 |