A phase I Study to Assess the Safety and Tolerability of MBF-362 in Healthy Women, and Preliminary Efficacy in Otherwise Healthy Women diagnosed with Primary Dysmenorrhea

Start 10 Dec 2025 · Status Ongoing, recruiting · 1 EU/EEA countries · 1 sites · Protocol MBF-362CT-02

Overview

Sponsor-declared trial summary

Phase Human pharmacology (Phase I) - Other

Status Ongoing, recruiting

Participants planned 24

Countries 1

Sites 1

Primary Dysmenorrhea

Key facts

Sponsor: Medibiofarma S.L.
Participant type: Healthy volunteers
Age range: 18-64 years
Gender: Female
Therapeutic area: Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]
Trial duration: 10 Dec 2025 → ongoing
Decision date (initial): 2025-08-12
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

Primary Dysmenorrhea

Version	Level	Code	Term	System organ class
21.1	LLT	10062851	Primary dysmenorrhea	10038604

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Medibiofarma S.L.

Sponsor organisation: Medibiofarma S.L.
Address: Poligono Industrial Mocholi 2 B, Noain C Noain C
City: Noain (Valle De Elorz)
Postcode: 31110
Country: Spain

Scientific contact point

Organisation: Medibiofarma S.L.
Contact name: Luc Marti Clauzel

Public contact point

Organisation: Medibiofarma S.L.
Contact name: Luc Marti Clauzel

Locations

1 EU/EEA country · 1 investigational sites

By country

Country	MS status	Planned subjects	Sites
Spain	Ongoing, recruiting	24	1
Rest of world	—	0	—

Investigational sites

Spain

1 site · Ongoing, recruiting

Fundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau

CIM, Calle Sant Quinti 77-79, 08041, Barcelona

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	2025-12-10		2026-01-21

Application history

2 submissions — initial application plus substantial / non-substantial modifications

#	Type	Code	Submitted	Reference MS	Conclusion	Decision date
1	INITIAL	IN	2025-05-16	Spain	Acceptable with conditions 2025-08-11	2025-08-12
2	SUBSTANTIAL MODIFICATION	SM-1	2025-09-12	Spain	Acceptable with conditions 2025-11-27	2025-12-01