Clinical trial • Phase I • Other
Levonorgestrel for Healthy volunteers
Phase I trial of Levonorgestrel for Healthy volunteers. Randomised, open-label, none/not specified-controlled. 60 participants.
Overview
- Trial Therapeutic Area
- Other
- Trial Disease
- Healthy volunteers
- Trial Stage
- Phase I
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 12-12-2025
- First CTIS Authorization Date
- 27-03-2026
Trial design
Randomised, open-label, none/not specified-controlled Phase I trial across 1 site in Spain.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- None/Not specified
- Target Sample Size
- 60
- Trial Duration For Participant
- 74
Eligibility
Recruits 60 isVulnerablePopulationSelected: true; no further details on vulnerable population, consent or assent handling provided in the record..
- Vulnerable Population
- isVulnerablePopulationSelected: true; no further details on vulnerable population, consent or assent handling provided in the record.
Recruitment
- Planned Sample Size
- 60
- Recruitment Window Months
- 2
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 60
Spain
- Earliest CTIS Part Ii Submission Date
- 17-12-2025
- Latest Decision Or Authorization Date
- 27-03-2026
- Processing Time Days
- 100
- Number Of Sites
- 1
- Number Of Participants
- 60
Sites
- Site Name
- Women Hub Medical Services S.L.
- Department Name
- Phase I Unit
- Contact Person Name
- Luciana Bergamaschi
- Contact Person Email
- luciana.bergamaschi@maximahealth.com
- Number Of Participants
- 60
Sponsor
Primary sponsor
- Full Name
- Chemo Research S.L.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Spain
Investigational products
- Investigational Product Name
- Levonorgestrel Vaginal Delivery System
- Active Substance
- Levonorgestrel
- Modality
- Small molecule
- Routes Of Administration
- Vaginal
- Route
- Vaginal
- Frequency
- Different days of use
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