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Gender Dysphoria clinical trials

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NCT ID: NCT06351501 Not yet recruiting - Clinical trials for Cross Sex Hormonal Treatment in Adolescents With Gender Dysphoria

Evaluation of the Effectiveness of Hormonal Treatment in Adolescents Suffering From Gender Dysphoria

TRANSADO
Start date: June 6, 2024
Phase: Phase 3
Study type: Interventional

Gender dysphoria (GD) is a significant suffering lasting more than 6 months in a subject, regarding the gap felt between gender identity of someone and birth sex. From the start of puberty, most of these adolescents who identify as transgender will persist in this sense and will engage in hormonal-surgical reassignment at some stage. For these adolescents, International recommendations for good practice recommend early treatment at the beginning of pubertal development (Tanner 2) to block pubertal progression, with the possibility of hormonal transition by administration of sex hormones of the desired sex at the age of 16. However, in order to reduce the psychosocial consequences of GD, more and more reference teams are practicing this hormonal transition from the age of 14 without any randomized study showing its benefit compared to a transition at the age of 16 years old. Indeed, in the absence of treatment, comorbidities among adolescents suffering from gender dysphoria is very high, with anxiety and depression, suicidal risk and school dropout. Our hypothesis is that when hormonal transition is started at an age closer to what physiological puberty would be, it will reduce comorbidities and improve quality of life of these adolescents. This is the first therapeutic randomized study in France on this transgender adolescent population, a field where international recommendations based on "Evidence Based Medicine" principles are scared. We hope that results of this study will guide transgender youth health care allowing them, if the study is positive, to access hormonal treatments earlier and improve their overall functioning, their anxious and depressive symptoms, their quality of life.

NCT ID: NCT05903911 Not yet recruiting - Gender Dysphoria Clinical Trials

Trans Care: An Online Intervention to Reduce Symptoms of Gender Dysphoria

Start date: October 2024
Phase: N/A
Study type: Interventional

The current project aims to improve the well-being of trans and nonbinary (TNB) individuals through an online intervention (Trans Care) targeting the reduction of symptoms of gender dysphoria. The Trans Care intervention will involve the creation of an online intervention comprised of eight modules intended to reduce symptoms of gender dysphoria, increase active coping, and improve the well-being of TNB individuals. Aim 2 is a randomized controlled trial of the proposed intervention and will enroll 260 TNB participants.

NCT ID: NCT05884307 Not yet recruiting - Gender Dysphoria Clinical Trials

Trans Care: An Online Intervention to Reduce Symptoms of Gender Dysphoria

Start date: May 2024
Phase: N/A
Study type: Interventional

The current project aims to improve the well-being of trans and nonbinary (TNB) individuals through an online intervention (Trans Care) targeting the reduction of symptoms of gender dysphoria. The Trans Care intervention will involve the creation of an online intervention comprised of eight modules intended to reduce symptoms of gender dysphoria, increase active coping, and improve the well-being of TNB individuals. Aim 1 is a feasibility and acceptability study of the proposed intervention and will enroll 100 TNB participants to provide feedback to inform a follow-up randomized controlled trial.

NCT ID: NCT05583058 Not yet recruiting - Gender Dysphoria Clinical Trials

Sex Hormone Overdose and Misuse in Chinese Transgender and Gender Non-conforming Population

HODMChina
Start date: December 15, 2022
Phase:
Study type: Observational [Patient Registry]

The investigators propose to investigate the definition of hormone overdose and misuse (HODM) in Chinese transgender and gender nonconforming population (TGNCs), address the incidence of HODM in Chinese TGNC population, related factors and risks, identify the probable causes of HODM, and follow up HODM individuals to explore long-term effects. The research questions are: Q1 What is the definition and the criteria of HODM in Chinese TGNC population? Q2 What is the prevalence of HODM in Chinese TGNC population? Q3 What factors and risks are relevant to HODM? Q4 What are the causes? Q5 What are the long-term effects of HODM in Chinese TGNC population, compared to those who enroll in regular GAHT regimens? The investigators decide to employ a mixed-methods design to construct a full research framework on HODM. A prospective cohort study is a component of the study. The study can be divided into four stages to address research questions. Stage I will establish a precise definition and eligibility criteria of HODM through expert panel meeting and stakeholder engagement. Subsequently, a cross-sectional study will be conducted to evaluate the rate, subtypes, and related factors of HODM in Chinese TGNCs. In Stage III, semi-structured interviews and focus groups for TGNCs who are identified as HODM will be employed to investigate the causes, motivations and personal impact factors. This stage will be divided into two phases, Stage III-a before the cross-sectional study to provide a brief picture of HODM behaviors, and Stage III-b after the cross-sectional study to draw an overall pattern. Lastly, all participants of Stage II or III who would like to participate in our follow-up will be included in prospective cohorts to assess long-term effects. Among the stages, the cohort study is the subject of the registration. The investigators propose two cohorts in the study. Participants who are identified as HODM will be assigned to cohort 1 [HODM cohort], and those who are identified as regular GAHT use will be assigned to cohort 2 [non-HODM cohort]. Participants will be asked to report their gender-related and hormone use-related conditions, and mental health-related conditions at specific timepoints. The investigators will compare the HODM cohort to the non-HODM cohort to see if the overall incidence of adverse effects, gender-related, hormone-related, and mental health-related conditions differ in the cohorts.

NCT ID: NCT05273112 Not yet recruiting - Gender Dysphoria Clinical Trials

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

TRANS'ITION
Start date: April 2023
Phase:
Study type: Observational

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.

NCT ID: NCT04265885 Not yet recruiting - Gender Dysphoria Clinical Trials

Gender Dysphoria and Transition

DyGePeT
Start date: October 2020
Phase:
Study type: Observational

Persons with gender dysphoria present the difficulties of access to health care. Little time is devoted to education of health professionals about the care of transgender persons. According to the proposal of the French Ministry of Social Affairs and Health there is a need to increase knowledge in this area and to improve the care of transgender people including prevention and screening. Similarly, little is known about social and medical needs of the transgender population. This project proposes to illustrate gender dysphoria through testimonies of transgender people with the aim to increase the investigator's understanding aout the needs and the desires of this population and to describe the process of medical and social transition.

NCT ID: NCT04160364 Not yet recruiting - Gender Dysphoria Clinical Trials

Gender Dysphoria in Children and Adolescents : Parents' Perspectives

GeDyPar
Start date: October 2020
Phase:
Study type: Observational

Gender dysphoria is defined as a persistent incongruence between an experienced gender and the assigned sex at birth Transgender and gender nonconforming persons desire to modify their appearance to be consistent with their self-identified gender identities. In non-binary people, contrary to binary transgender persons, self-identified gender identities do not fit the classical pattern male/female. During the last decennium, an increase in the number of young subjects, especially children and adolescents, referred to gender identity centres has been observed. A new nosological entity "rapid-onset gender dysphoria in adolescents and young adults" has recently been described in the literature, whose etiology has not been well understood. This growing demand of adolescents and young adults observed in the recent years is not well understood.