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
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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