Clinical trial • Phase I • Other
Testosterone
Phase I trial of Testosterone. None/Not specified-controlled. 24 participants.
Overview
- Trial Therapeutic Area
- Other
- Trial Stage
- Phase I
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 11-08-2025
- First CTIS Authorization Date
- 02-12-2025
Trial design
None/Not specified-controlled Phase I trial across 2 sites in Spain.
- Comparator
- None/Not specified
- Target Sample Size
- 24
Eligibility
Recruits 24 No vulnerable populations selected; trial enrolls postmenopausal female healthy volunteers. Consent/assent processes not specified..
- Vulnerable Population
- No vulnerable populations selected; trial enrolls postmenopausal female healthy volunteers. Consent/assent processes not specified.
Recruitment
- Planned Sample Size
- 24
- Recruitment Window Months
- 4
Geography
- Total Number Of Sites
- 2
- Total Number Of Participants
- 24
Spain
- Earliest CTIS Part Ii Submission Date
- 19-09-2025
- Latest Decision Or Authorization Date
- 28-01-2026
- Processing Time Days
- 131
- Number Of Sites
- 2
- Number Of Participants
- 24
Sites
- Site Name
- Women Hub Medical Services S.L.
- Department Name
- Medical Management
- Contact Person Name
- Luciana Bergamaschi
- Contact Person Email
- luciana.bergamaschi@maximahealth.com
- Site Name
- Hospital De La Santa Creu I Sant Pau
- Department Name
- Medical Management
- Contact Person Name
- Pol Molina Perello
- Contact Person Email
- PMolinaP@santpau.cat
Sponsor
Primary sponsor
- Full Name
- Chemo Research S.L.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Spain
Investigational products
- Investigational Product Name
- 3 testosterone gel formulations
- Active Substance
- Testosterone
- Modality
- Small molecule
- Routes Of Administration
- Topical (gel)
- Route
- Topical (gel)
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