NCT04935164

Brief Summary

Gender dysphoria is manifested by an internal tension between biological sex and gender, that is, by a non-congruence, in the subjects who suffer from it, between their sex of birth and their social gender identity.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
44mo left

Started Mar 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress59%
Mar 2021Dec 2029

First Submitted

Initial submission to the registry

February 26, 2021

Completed
28 days until next milestone

Study Start

First participant enrolled

March 26, 2021

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 22, 2021

Completed
7.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2029

Expected
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2029

Last Updated

June 5, 2025

Status Verified

June 1, 2025

Enrollment Period

7.9 years

First QC Date

February 26, 2021

Last Update Submit

June 3, 2025

Conditions

Gender Dysphoria, Adult

Outcome Measures

Primary Outcomes (5)

  • Contribution of temporal parameters of microstates C, D, E and F

    The proportion of the total time spent in microstates of class C,D,E and F

    Week 1 to Week 24

  • Duration of temporal parameters of microstates C, D, E and F

    Week 1 to Week 24

  • Mean-Global Field Power temporal parameters of microstates C, D, E and F

    Week 1 to Week 24

  • Occurrence of temporal parameters of microstates C, D, E and F

    Week 1 to Week 24

  • Cortical voxel activity from source reconstruction analysis, using electroencephalogram during Double Mirror Test (D.M.T).

    Week 1 to Week 24

Study Arms (4)

Male patients with gender dysphoria

* male patients with gender dysphoria according to DSM-V criteria (axis I), confirmed by MINI evaluation * patients without psychotropic treatments * patients who do not benefit of hormone therapy * patients who have not yet received gender reassignment surgery * patients aged 18 to 60 years * patients with normal or corrected vision * patients without mental defect * patients without neurological impairment

Other: Psychiatric evaluations

Female patients with gender dysphoria

* female patients with gender dysphoria according to DSM-V criteria (axis I), confirmed by MINI evaluation * patients without psychotropic treatments * patients who do not benefit of hormone therapy * patients who have not yet received gender reassignment surgery * patients aged 18 to 60 years * patients with normal or corrected vision * patients without mental defect * patients without neurological impairment

Other: Psychiatric evaluations

Male volunteers without gender dysphoria

* male volunteer without gender dysphoria according to DSM-V criteria (axis I), confirmed by MINI evaluation * volunteer aged 18 to 60 years * volunteer with normal or corrected vision * volunteer without mental defect * volunteer without neurological impairment

Other: Psychiatric evaluations

Female volunteers without gender dysphoria

* female volunteer without gender dysphoria according to DSM-V criteria (axis I), confirmed by MINI evaluation * volunteer aged 18 to 60 years * volunteer with normal or corrected vision * volunteer without mental defect * volunteer without neurological impairment

Other: Psychiatric evaluations

Interventions

Psychiatric evaluationsOTHER

At different time points, several psychiatric evaluations will be performed on patients and volunteers for study purposes

Also known as: Electroencephalography, Double Mirror Test, Mini International Neuropsychiatric Interview, Montgomery-Åsberg Depression Rating Scale, Hamilton Rating Scale for Depression
Female patients with gender dysphoriaFemale volunteers without gender dysphoriaMale patients with gender dysphoriaMale volunteers without gender dysphoria

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Contact sponsor for more details

You may qualify if:

  • Patients with gender dysphoria
  • Without psychotropic
  • Without hormono-therapy
  • Without sexual surgery assignation

You may not qualify if:

  • Any depression
  • Any addiction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Henri Laborit

Poitiers, 86021, France

RECRUITING

MeSH Terms

Conditions

Gender Dysphoria

Interventions

Psychiatric Status Rating Scales

Condition Hierarchy (Ancestors)

Sexual Dysfunctions, PsychologicalMental Disorders

Intervention Hierarchy (Ancestors)

Neuropsychological TestsPsychological TestsBehavioral Disciplines and Activities

Central Study Contacts

Bérangère Thirioux, PhD

CONTACT

0033 5 49 44 58 56berangere.thirioux@ch-poitiers.fr

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2021

First Posted

June 22, 2021

Study Start

March 26, 2021

Primary Completion (Estimated)

March 1, 2029

Study Completion (Estimated)

December 1, 2029

Last Updated

June 5, 2025

Record last verified: 2025-06

Locations

FR(1)