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NCT Number: NCT05273112

Evaluation of the Variation in Quality of Life During Medical Transition 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.

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Key information

Conditions

Gender Dysphoria Mental Disorders Sexual Dysfunctions, Psychological

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Bordeaux, Bordeaux, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. Quality of life scores

    Time frame: 3 years

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

Secondary outcomes

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

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

    Answers given by the patient during interview

  2. Satisfaction of the shared medical decision

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

    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)

  3. Satisfaction of body image

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

    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

  4. General psychopathology

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

    French version of Mini International Neuropsychiatric Interview (DSM)

  5. Anxiety and depression

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

    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

  6. Quality of life scores

    Time frame: 6 months, 12 months, 18 months, 24 months, 30 months, 5 years

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

Study contacts

Contact information is provided by the study sponsor or research team.

François MEDJKANE, MD

CONTACT

[email protected]

0320445962 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Official study title

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

Acronym: TRANS'ITION

Important dates

Study start
2027
Primary completion
2030
Study completion
2030
First posted
Mar 10, 2022
Registry last updated
May 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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