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Gender DysphoriaTRANS'ITIONNCT05273112

Evaluation of the Variation in Quality of Life During Medical Transition for Transgender People.

An observational study of Gender Dysphoria, run by University Hospital, Lille at 13 sites in France.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Transgender people can benefit from psychological, psychiatric, endocrinological support, sexual reassignment surgery, sexology support and dermatological care. The value of transitional care courses is scientifically recognized. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Gender Dysphoria
How many people
400 participants
Where
13 sitesFrance
Study dates
Jan 2027to Apr 2030
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: transgender people in medical transition

Who may be able to join

  • With a diagnosis of Gender Dysphoria according to DSM5 diagnostic criteria
  • Wishing to benefit from supportive care for their transition trajectory and addressing a care system represented by the collaborating centers participating in the study,
  • Willing to comply with all study procedures and duration,
  • Understanding and able to speak French.

Who cannot join

  • Minor or adult under curatorship, under judicial protection, persons deprived of their liberty
  • Refusal to participate after clear and fair information from the study
  • Person with sexual reassignment surgery or with cross hormon therapy since two years.

Trial locations and contacts

13 sites in 1 country. Contact the study team or a site near you to ask about taking part.

François MEDJKANE, MD contact

0320445962 ext. +33

francois.medjkane@chru-lille.fr

13 sites in 1 country

France13 sites

  • Centre Hospitalier de Béziers

    Béziers

    Cyril IMBERT

  • CHU de Bordeaux

    Bordeaux

    Romain WEIGERT

  • CHU de Brest

    Brest

    Véronique KERLAN

  • CHU de Caen

    Caen

    Yves REZNIK

    Bleuenn DREVES

  • CHU de Lille

    Lille

    Francois MEDJKANE

    Anne-Laure DEMARTY

  • Maison de Santé Lille Moulins

    Lille

    Nassir MESSAADI

  • Maison de Santé Lille Sud

    Lille

    Sophie DUPONT

    Gwendoline EECKHOUT

  • CHU de Lyon

    Lyon

    Ludovic SOUILLER

    Lucie JUREK

  • G..R.E.T.T.I.S

    Lyon

    Nicolas MOREL-JOURNEL

  • Hopital de la Conception - Marseille

    Marseille

    Delphine DRAI

  • CHU de Nice

    Nice

    Michel BENOIT

  • Centre Hospitalier Maison Blanche

    Paris

    Jean CHAMBRY

  • Centre Hospitalier Sainte-Anne

    Paris

    Thierry GALLARDA

Other trials in France

About this study

Official title: Evaluation of the Variation in Quality of Life During Medical Transition According Different Modalities of Supported Care for Transgender People.

Transgender people can benefit from psychological, psychiatric, endocrinological support, sexual reassignment surgery, sexology support and dermatological care. The value of transitional care courses is scientifically recognized. Currently, the modalities of decision and realization of the care paths are heterogeneous on the territory, little standardized, and are the subject of debates between representatives of users and medical teams.

The french national report of IGAS from 2011 warns of the need to argue and legitimize care practices through more numerous, more exhaustive scientific studies, presenting a better level of evidence

Since 2011, no prospective study has been carried out on the national and international level, making it possible to assess the relevance of the planned care modalities. This research project, conducted over five consecutive years at the first contact of a transgender people with a care device, aims to correlate a variation in the quality of life of people with the characteristics of the care methods provided. This is a first proposal to assess care practices for transgender people. The results of this study would first allow us to infer the care modalities most suited to the needs of people. Secondly, secondary hypotheses could support new experimental protocols.

Read the detailed description

This research is a prospective multicenter cohort study with a 3-year and 5-year follow-up of transgender people in medical transition.

Main aim:

Evaluate the evolution of the quality of life during five years in transgender people who benefit from transition support cares.

Secondary objectives:

Secondary objective n°1 :

Identify the different factors that influence the evolution of quality of life evaluated over three years in transgender people who benefit from transition support cares.

Secondary objective n°2 :

Evaluate the evolution of the satisfaction of the shared medical decision for transgender people in medical transition.

Secondary objective n°3 :

Evaluate the evolution of the satisfaction of body image for transgender people in medical transition.

Secondary objective n°4 :

Evaluate the evolution of psychiatric comorbidities for transgender people in medical transition.

Secondary objective n°5 :

Evaluate the benefits and limits in long term (five years) on the quality of life, the satisfaction of the shared medical decision, the satisfaction of body image and the evolution of psychiatric comorbidities.

Keywords
Transidentity, Gender Dysphoria, Transition, Quality of Life
Medical subject headings
Gender Dysphoria

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Quality of life scores

    Scores on the WHOQOL BREF (World Health Organisation Quality Of Life) scale

    Measured: 3 years

Secondary outcomes (6)

  1. Social factors (age, gender, profession, knowledge of care system)

    Answers given by the patient during interview

    Measured: Baseline and 6 months, 12 months, 18 months, 24 months, 30 months, 3 years and 5 years

  2. Satisfaction of the shared medical decision

    Scores on the CDIS (Clinical Decision-making Involvement and Satisfaction) clinical decision making involvement and satisfaction score 15 questions scored 1-5 (totally disagree, strongly disagree, neither agree nor disagree, strongly agree, totally agree)

    Measured: 6 months, 12 months, 18 months, 24 months, 30 months, 3 years and 5 years

  3. Satisfaction of body image

    Score on the BIS (Body Image Scale), total score ranges from 0 to 30, A higher score means a higher level of body image disturbance

    Measured: 6 months, 12 months, 18 months, 24 months, 30 months, 3 years and 5 years

  4. General psychopathology

    French version of Mini International Neuropsychiatric Interview (DSM)

    Measured: 6 months, 12 months, 18 months, 24 months, 30 months, 3 years and 5 years

  5. Anxiety and depression

    Anxiety and depression scores on the HAD scale (Hospital Anxiety and Depression scale), a score upper 8 means is considered as a risk of an anxiety or depressive disorder

    Measured: 6 months, 12 months, 18 months, 24 months, 30 months, 3 years and 5 years

  6. Quality of life scores

    Scores on the WHOQOL BREF (World Health Organisation Quality Of Life) scale

    Measured: 6 months, 12 months, 18 months, 24 months, 30 months, 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Mar 2022
  2. Study startJan 2027 (estimated)
  3. Primary completionApr 2030 (estimated)
  4. Study completionApr 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05273112
Sponsor's protocol ID
2020_09
Other IDs
2021-A00154-37, PREPS-19-0078
Acronym
TRANS'ITION
Status last verified
May 2026
First submitted
24 Dec 2021
Last updated
20 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Gender Dysphoria, run by University Hospital, Lille at 13 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact François MEDJKANE, MD (0320445962 ext. +33, francois.medjkane@chru-lille.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Quality of life scores (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05273112.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.

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