Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruiting
Participants planned
60
Countries
1
Sites
6
Stress or mixed urinary incontinence in women over 50 years of age not responding to conventional treatments
Key facts
- Sponsor
- Instituto De Investigacion Sanitaria Fundacion Jimenez Diaz
- Participant type
- Patients
- Age range
- 65+ years
- Gender
- Female
- Therapeutic area
- Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]
- Trial duration
- 16 Dec 2024 → ongoing
- Decision date (initial)
- 2024-10-07
- 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
Stress or mixed urinary incontinence in women over 50 years of age not responding to conventional treatments
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Instituto De Investigacion Sanitaria Fundacion Jimenez Diaz
- Sponsor organisation
- Instituto De Investigacion Sanitaria Fundacion Jimenez Diaz
- Address
- Calle De Isaac Peral 42 Oficinas 2a Planta Oficina 1
- City
- Madrid
- Postcode
- 28015
- Country
- Spain
Scientific contact point
- Organisation
- Instituto De Investigacion Sanitaria Fundacion Jimenez Diaz
- Contact name
- Lucia Llanos
Public contact point
- Organisation
- Instituto De Investigacion Sanitaria Fundacion Jimenez Diaz
- Contact name
- Lucia Llanos
Locations
1 EU/EEA country · 6 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ongoing, recruiting | 60 | 6 |
| Rest of world | — | 0 | — |
Investigational sites
Hospital Universitario Del Henares
Urologia, Avenida De Marie Curie S/n, 28822, Coslada
Hospital Universitario Fundacion Jimenez Diaz
Urologia, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital Universitario 12 De Octubre
Urologia, Bloque D, Avenida De Cordoba Sn, Madrid
Hospital Universitario Infanta Elena
Urologia, Avenida De Los Reyes Catolicos 21 Valdemoro, 28040, Madrid
Hospital Universitario General De Villalba
Urologia, Carretera De Alpedrete A Moralzarzal M-608 Km 41, 28400, Collado Villalba
Hospital Universitario Rey Juan Carlos
Urologia, Calle Gladiolo S/n, 28933, Mostoles
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 |
|---|---|---|---|---|---|
| Spain | 2024-12-16 | 2025-02-07 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-06-13 | Spain | Acceptable 2024-10-07
|
2024-10-07 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-11-19 | Spain | Acceptable 2024-10-07
|
2024-11-19 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-06-23 | Spain | Acceptable with conditions 2025-08-11
|
2025-09-01 |