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Clinical Trials/2024-517052-35-00
2024-517052-35-00
Not yet recruiting
Phase 4

Early mental response to hormonal treatment in transgender men

Karolinska University Hospital1 site in 1 country70 target enrollmentOctober 1, 2024
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Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Not specified
Sponsor
Karolinska University Hospital
Enrollment
70
Locations
1
Status
Not yet recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
euclinicaltrials.eu
Start Date
October 1, 2024
End Date
TBD
Last Updated
last year
Study Type
Interventional clinical trial of medicinal product
Sex
Female

Investigators

Sponsor
Karolinska University Hospital
Responsible Party
Principal Investigator
Principal Investigator

Mats Holmberg

Scientific

Karolinska University Hospital

Eligibility Criteria

Inclusion Criteria

  • •\- Transgender men diagnosed with gender dysphoria, as defined in the ICD\-10\.
  • •\- A wish for full gender\-affirming HRT
  • •\-Signed informed consent to trial participation consistent with ICH\-GCP guidelines and local legislations
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range 50
  • •F.1\.3 Elderly (\>\=65 years) no
  • •F.1\.3\.1 Number of subjects for this age range

Exclusion Criteria

  • •\- Any concomitant hormonal disease
  • •\- Any disability that prevents the patient from fully participating in the study.
  • •\- Previous hormonal treatment within three months before the study period (such as HRT using illegally obtained medications).
  • •\- Hormonal levels before intervention that differ significantly from physiological levels for assigned sex (suggesting illegal HRT or hormonal disease).

Outcomes

Primary Outcomes

Not specified

Study Sites (1)

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