Phase 1, Randomized, Open-label, Single center study to evaluate Pharmacokinetic and Bioequivalence of Levonorgestrel Vaginal Delivery System in Healthy Female Volunteers after different days of use

2025-524330-25-00 Protocol LR-105 Human pharmacology (Phase I) - Other Ongoing, recruiting

Start 21 Apr 2026 · Status Ongoing, recruiting · 1 EU/EEA countries · 1 sites · Protocol LR-105

Overview

Sponsor-declared trial summary

Phase Human pharmacology (Phase I) - Other
Status Ongoing, recruiting
Participants planned 60
Countries 1
Sites 1

No medical condition

Key facts

Sponsor
Chemo Research S.L.
Participant type
Healthy volunteers
Age range
18-64 years
Gender
Female
Therapeutic area
Not possible to specify
Trial duration
21 Apr 2026 → ongoing
Decision date (initial)
2026-03-27
Transition trial
No
Low-intervention
No
Rare-disease indication
No
Vulnerable population
Yes

Trial design

CTIS Part I — objectives, methods, condition coding

Conditions and MedDRA coding

No medical condition

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Chemo Research S.L.

Sponsor organisation
Chemo Research S.L.
Address
3rd Floor, Calle De Manuel Pombo Angulo 28 Calle De Manuel Pombo Angulo 28
City
Madrid
Postcode
28050
Country
Spain

Scientific contact point

Organisation
Chemo Research S.L.
Contact name
Enrico Colli

Public contact point

Organisation
Chemo Research S.L.
Contact name
Enrico Colli

Locations

1 EU/EEA country · 1 investigational sites

By country

CountryMS statusPlanned subjectsSites
Spain Ongoing, recruiting 60 1
Rest of world 0

Investigational sites

Spain

1 site · Ongoing, recruiting
Women Hub Medical Services S.L.
Phase I Unit, Calle Muntaner 292, 08021, Barcelona

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
Spain 2026-04-21 2026-04-22

Application history

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

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2025-12-12 Spain Acceptable
2026-03-23
2026-03-27