Clinical trial • Phase III • Other
2-Methoxyestradiol
Phase III trial of 2-Methoxyestradiol. adaptive. 60 participants.
Overview
- Trial Therapeutic Area
- Other
- Trial Stage
- Phase III
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 14-08-2025
- First CTIS Authorization Date
- 29-09-2025
Trial design
adaptive Phase III trial across 1 site in Portugal.
- Adaptive
- True: Multiple-ascending dose escalation; no specific dose-escalation rules, interim analyses or stopping rules provided in the record.
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 60
- Trial Duration For Participant
- 337
Eligibility
Recruits 60 Vulnerable population selected (isVulnerablePopulationSelected = true); no further details on consent or assent handling are provided in the record..
- Pregnancy Exclusion
- Healthy Non-Pregnant Female Participants.
- Vulnerable Population
- Vulnerable population selected (isVulnerablePopulationSelected = true); no further details on consent or assent handling are provided in the record.
Recruitment
- Planned Sample Size
- 60
- Recruitment Window Months
- 11
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 60
Portugal
- Earliest CTIS Part Ii Submission Date
- 19-09-2025
- Latest Decision Or Authorization Date
- 13-04-2026
- Processing Time Days
- 206
- Number Of Sites
- 1
- Number Of Participants
- 60
Sites
- Site Name
- Blueclinical Investigacao E Desenvolvimento Em Saude Lda.
- Department Name
- Medical Management
- Contact Person Name
- Marlene Fonseca
- 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
- 2-Methoxyestradiol
- Active Substance
- 2-Methoxyestradiol
- Modality
- Small molecule
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