Ongoing Clinical Trials for Gender Dysphoria
There is currently 1 ongoing clinical trial investigating hormonal treatment for adolescents with gender dysphoria. The trial is evaluating the effectiveness of estradiol hemihydrate and testosterone in supporting young people through their gender transition, with a focus on overall functioning and well-being.
Clinical trial locations
Study on the Effectiveness of Hormonal Treatment with Estradiol Hemihydrate and Testosterone in Adolescents with Gender Dysphoria
This clinical trial is evaluating hormonal treatment for adolescents experiencing gender dysphoria, a condition where a person feels strong discomfort with the gender they were assigned at birth. The study aims to understand how these treatments affect the overall well-being and functioning of young people going through gender transition.
Main focus and goal: The trial focuses on assessing the effectiveness of hormonal treatment in supporting adolescents with gender dysphoria. The study will monitor participants from around age 14 until they are approximately 16 years old, tracking both their mental and physical health. Researchers will use various assessment tools, including the Children’s Global Assessment Scale, to measure overall functioning. The goal is to gather information about the long-term effects of these treatments, which can help improve care and support for this population. The study is expected to continue until 2031.
Investigational drugs being tested: The trial uses two main types of hormones. Estradiol hemihydrate is provided in two forms: PROVAMES 1 mg (film-coated tablets) and ESTREVA 0.1% (gel). Testosterone is provided as ANDROGEL 16.2 mg/g (gel). These hormones work by binding to specific receptors in the body to promote the development of physical characteristics that align with the person’s gender identity.
Who can participate: The trial is looking for adolescents who are 14 years old (give or take 6 months) and have started puberty. Participants must have a confirmed diagnosis of gender dysphoria according to professional guidelines, verified through at least two interviews with child psychiatrists, spaced six months apart. Young people must have reached specific stages of pubertal development, measured by the Tanner score (stage 2 or higher). The need for hormonal treatment must be approved by a team of healthcare professionals, including at least one consultation with a pediatric endocrinologist who specializes in hormones in children.
Who cannot participate: The trial excludes several groups of young people. Those who have not completed their social transition (changes like name, pronouns, and clothing to match their gender identity) cannot join. The trial also excludes anyone younger than 13 and a half years old or older than 16 and a half years old. Additionally, young people who are unable to receive hormonal treatment with estrogens or testosterone for medical reasons are not eligible.
Summary
Currently, there is one clinical trial actively investigating hormonal treatment for adolescents with gender dysphoria. This trial is being conducted in France and represents an important effort to understand how hormone therapy impacts the overall well-being of young people during gender transition. The study uses both estradiol and testosterone in various formulations, following participants over a multi-year period to assess long-term outcomes. The trial employs comprehensive assessment methods to evaluate both psychological and physical health, providing valuable data that may help healthcare providers better support adolescents experiencing gender dysphoria.