Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
105
Countries
2
Sites
4
Healthy Post-menopausal women.
Key facts
- Sponsor
- Laboratorios Farmaceuticos Rovi S.A.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years, 65+ years
- Gender
- Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 20 Jul 2023 → 11 Mar 2026
- Decision date (initial)
- 2025-02-13
- 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
Healthy Post-menopausal women.
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10051775 | Postmenopause | 100000004869 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Laboratorios Farmaceuticos Rovi S.A.
- Sponsor organisation
- Laboratorios Farmaceuticos Rovi S.A.
- Address
- Calle De Julian Camarillo 35, Poligono Julian Camarillo Norte Poligono Julian Camarillo Norte
- City
- Madrid
- Postcode
- 28037
- Country
- Spain
Scientific contact point
- Organisation
- Laboratorios Farmaceuticos Rovi S.A.
- Contact name
- Rovi Medical Department
Public contact point
- Organisation
- Laboratorios Farmaceuticos Rovi S.A.
- Contact name
- Rovi Medical Department
Locations
2 EU/EEA countries · 4 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Bulgaria | Ended | 15 | 2 |
| Czechia | Ended | 90 | 2 |
| Rest of world | — | 0 | — |
Investigational sites
Medical Center Comac Medical Ltd.
N/A, Ulitsa Urvich 13, Krasno Selo District, Sofia
Medical Center Comac Medical Ltd.
N/A, Ulitsa Sveti Georgi Sofiyski 3, 1606, Sofia
Quinta-Analytica s.r.o.
N/A, Umelecka 305/1, Moravska Ostrava, Moravska Ostrava A Privoz
Quinta-Analytica s.r.o.
Klinika onkologie a radioterapie, Prazska 1486/18c, Hostivar, Prague 15
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 |
|---|---|---|---|---|---|
| Czechia | 2023-07-20 | 2026-03-11 | 2023-07-20 | 2025-06-06 |
Application history
10 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-03-22 | Czechia | Acceptable 2023-07-11
|
2023-07-12 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2023-08-29 | Czechia | Acceptable 2023-07-11
|
2023-08-29 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-10-05 | Czechia | Acceptable 2023-11-15
|
2023-11-16 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-01-15 | Czechia | Acceptable 2023-11-15
|
2024-01-15 |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-01-29 | Czechia | Acceptable 2024-02-26
|
2024-04-16 |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2024-07-05 | Czechia | Acceptable 2024-02-26
|
2024-07-05 |
| 7 | SUBSEQUENT ADDITION OF MSC | APP-7 | 2024-11-20 | Acceptable 2024-02-26
|
2025-02-13 | |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2025-05-13 | Czechia | Acceptable 2024-02-26
|
2025-05-13 |
| 9 | NON SUBSTANTIAL MODIFICATION | NSM-5 | 2025-09-04 | Czechia | Acceptable 2024-02-26
|
2025-09-04 |
| 10 | NON SUBSTANTIAL MODIFICATION | NSM-6 | 2026-03-24 | Czechia | Acceptable 2024-02-26
|
2026-03-24 |