Developmental Correlates and Hormone Therapy Effects in Gender Dysphoria

NCT04309760 | Withdrawn

• 1 other identifier: 2019-A01997-50
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of the research is to study longitudinally the effects of reassignment hormonotherapy on the connectome of MtF (biological men who are transitioning to the female gender) dysphoric subjects after 6 months of hormone therapy. The subjects will be compared to a control group of healthy subjects taking into account sexual orientation

Conditions

Gender Dysphoria

Keywords

gender dysphoria; neuroimaging; hormone-surgical reassignment

Outcome Measures

Primary Outcomes (1)

• Brain connectome 6 months after the hormone therapy beginning

  Structural and functional MRI before and after 6 months of hormone therapy will be analysed in order to make a comparison before/after

  6 months after the beginning of the hormone therapy

Secondary Outcomes (3)

• Brain connectome in gender dysphoric and control subjects

  baseline

• Gender dysphoria phenotype description

  baseline and 6 months after the beginning of the hormone therapy

• Brain connectome variations

  6 months after the beginning of the hormone therapy

Study Arms (2)

gender dysphoria subjects

ACTIVE COMPARATOR

Patients with MtF gender dysphoria (biological men who are transitioning to the female gender) attending the forensic psychiatric consultation for a request for hormone-surgical reassignment. Subjects will receive initial clinical assessment and MRI before and 6 months after initiation of hormone therapy

Other: MRI

control subjects

OTHER

Control group inclusions, of open-label patients without gender dysphoria.

Other: MRI

Interventions

MRI OTHER

Subjects will receive structural and functional (resting state) MRI

control subjects; gender dysphoria subjects

Eligibility Criteria

• Age: 18 Years - 50 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• gender dysphoric subjects MtF
• right handed
• androphilic orientation
• without hormone therapy
• Control group of male subjects:
• right handed
• without any psychiatric or medical history
• androphilic orientation

You may not qualify if:

• MRI contraindication
• vulnerable adults
• mental retardation
• psychiatric or neurological disease including autism spectrum disorders, psychotropic medication
• hormonal or genetic condition

Sponsors & Collaborators

• Hôpital le Vinatier: lead

MeSH Terms

Conditions

Gender Dysphoria

Condition Hierarchy (Ancestors)

Sexual Dysfunctions, Psychological; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Comparison between Mtf and control subjects.

Study Record Dates

• First Submitted: February 18, 2020
• First Posted: March 16, 2020
• Study Start: February 1, 2021
• Primary Completion: June 15, 2021
• Study Completion: March 15, 2022
• Last Updated: June 10, 2026

Record last verified: 2026-06