Clinical trial • Phase II • Other
Levonorgestrel for Healthy volunteers
Phase II trial of Levonorgestrel for Healthy volunteers. Levonorgestrel 52 mg Intrauterine System versus Mirena®-controlled. 64 participants.
Overview
- Trial Therapeutic Area
- Other
- Trial Disease
- Healthy volunteers
- Trial Stage
- Phase II
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 26-09-2025
- First CTIS Authorization Date
- 10-11-2025
Trial design
Levonorgestrel 52 mg Intrauterine System versus Mirena®-controlled Phase II trial across 1 site in Portugal.
- Comparator
- Levonorgestrel 52 mg Intrauterine System versus Mirena®
- Target Sample Size
- 64
Recruitment
- Planned Sample Size
- 64
- Recruitment Window Months
- 15
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 64
Portugal
- Earliest CTIS Part Ii Submission Date
- 03-11-2025
- Latest Decision Or Authorization Date
- 21-01-2026
- Processing Time Days
- 79
- Number Of Sites
- 1
- Number Of Participants
- 64
Sites
- Site Name
- Blueclinical Investigacao E Desenvolvimento Em Saude Lda.
- Department Name
- Medical Management
- Contact Person Name
- Suzana Cecatto
- Contact Person Email
- phase1@blueclinical.pt
Sponsor
Primary sponsor
- Full Name
- Laboratorios Leon Farma S.A.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Spain
Investigational products
- Investigational Product Name
- Levonorgestrel 52 mg Intrauterine System
- Active Substance
- Levonorgestrel
- Modality
- Small molecule
- Routes Of Administration
- Intrauterine
- Route
- Intrauterine
- Starting Dose
- 52 mg
- Dose Levels
- 52 mg
- Investigational Product Name
- Mirena®
- Active Substance
- Levonorgestrel
- Modality
- Small molecule
- Routes Of Administration
- Intrauterine
- Route
- Intrauterine
- Starting Dose
- 52 mg
- Dose Levels
- 52 mg
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