Study on the Effectiveness of Hormonal Treatment with Estradiol Hemihydrate and Testosterone in Adolescents with Gender Dysphoria

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What is this study about?

This clinical trial is focused on evaluating the effectiveness of hormonal treatment in adolescents experiencing gender dysphoria. Gender dysphoria is a condition where a person feels a strong discomfort with the gender they were assigned at birth. The study involves the use of hormonal treatments, specifically estradiol hemihydrate and testosterone. Estradiol hemihydrate is available in two forms: a film-coated tablet called PROVAMES 1 mg and a gel known as ESTREVA 0.1%. Testosterone is provided in a gel form called ANDROGEL 16.2 mg/g.

The purpose of the study is to assess how these hormonal treatments affect the overall functioning of adolescents with gender dysphoria. The study will follow participants who have completed their social transition and may or may not have undergone prior pubertal suppression. The hormonal treatment will begin when the adolescents are around 14 years old, and their progress will be monitored until they are about 16 years old. The study aims to understand the impact of these treatments on various aspects of the adolescents’ lives, including their mental and physical health.

Participants in the study will receive either estradiol or testosterone, depending on their individual needs. The study will track their development and well-being over a period of time, using various assessments to measure their global functioning. The goal is to gather information that can help improve the care and support provided to adolescents with gender dysphoria. The study is expected to continue until 2031, providing valuable insights into the long-term effects of hormonal treatments in this population.

1 initiation of hormonal treatment

The trial begins with the initiation of hormonal treatment for adolescents diagnosed with gender dysphoria.

Participants are aged 14 years old, with a margin of 6 months, and have initiated puberty.

The treatment involves the use of estradiol hemihydrate and testosterone, administered orally.

The specific medications used are PROVAMES 1 mg (film-coated tablet), ANDROGEL 16.2 mg/g (gel), and ESTREVA 0.1% (gel).

2 monitoring and assessment

Participants’ global functioning is assessed using the Children’s Global Assessment Scale (CGAS) at age 16, with a margin of 6 months.

Secondary assessments include various psychological and physical health scales, such as the Global Assessment Scale (GAS), Weschler scale (WISC V), and others.

These assessments occur at different time points: selection visit, T0, T1, and T2.

3 evaluation of treatment effectiveness

The main objective is to evaluate the effectiveness of hormonal treatment on the overall functioning of the adolescent.

The evaluation considers both psychological and physical health outcomes, including potential side effects and changes in body measurements.

4 completion of the trial

The trial is estimated to end by June 25, 2031.

The final assessments will determine the long-term effectiveness and safety of the hormonal treatment for adolescents with gender dysphoria.

Who Can Join the Study?

Adolescents who are 14 years old, with a possible range of 6 months younger or older.
Have started puberty, which is a stage of development when a child’s body begins to change into an adult body. For female-to-male (FtM) individuals, this means having a Tanner score of 2 or higher. For male-to-female (MtF) individuals, it means having a Tanner score of 2 or higher, or a testosterone level greater than 0.3 ng/mL. The Tanner score is a scale that measures physical development during puberty.
Meet the criteria for gender dysphoria according to the DSM-5, which is a guide used by doctors to diagnose mental health conditions. This must be confirmed by at least two interviews with child psychiatrists, spaced at least six months apart. During these interviews, the diagnosis of gender dysphoria should be clearly established, and any related conditions like autism spectrum disorder or cognitive impairment should be ruled out. This is confirmed using specific questionnaires like the Gender Identity/Gender Dysphoria Questionnaire for Adults and Adolescents (GIDYQ-AA) and the Utrecht Gender Dysphoria Scale (UGDS).
The need for hormonal transition must be approved during a meeting with various healthcare professionals. This should happen after at least one consultation with a pediatric endocrinologist, who is a doctor specializing in hormones in children. During this consultation, there should be a clinical examination, blood pressure measurement, and information provided about hormonal treatments for gender dysphoria.

Who Cannot Join the Study?

Participants who have not completed their social transition related to gender dysphoria. Social transition involves changes like name, pronouns, and clothing to match one’s gender identity.
Participants who have not reached the age of 14 years, plus or minus 6 months. This means they should be between 13 and a half to 14 and a half years old.
Participants who are older than 16 years, plus or minus 6 months. This means they should not be older than 16 and a half years.
Participants who have not undergone prior pubertal suppression, if applicable. Pubertal suppression is a medical treatment that pauses the physical changes of puberty.
Participants who are not able to receive hormonal treatment with estrogens or testosterone. Estrogens and testosterone are hormones used to help develop physical traits that match one’s gender identity.

Where you can join this trial?

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Site Name	City	Country	Status
Hopital Beaujon	Clichy	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	25.06.2024

Trial locations

Investigated drugs:

Estrogens are hormones used in this trial to help adolescents who experience gender dysphoria and have completed their social transition. The treatment aims to support the development of physical characteristics that align with the individual’s gender identity.

Testosterone is another hormone used in this trial for adolescents with gender dysphoria. It is intended to promote the development of physical traits that match the individual’s gender identity, helping them feel more comfortable in their bodies.

Gender Dysphoria – Gender dysphoria is a condition where an individual experiences discomfort or distress because their gender identity differs from the sex they were assigned at birth. This condition can manifest in various ways, including a strong desire to be treated as another gender or to change one’s physical characteristics to align with their gender identity. The progression of gender dysphoria can vary greatly among individuals, with some experiencing increased distress over time if their gender identity is not affirmed. Social transition, such as changing one’s name, pronouns, or appearance, can be part of the process for some individuals. Hormonal treatments may also be considered to help align physical characteristics with gender identity. The condition is recognized as a significant aspect of mental health and well-being for those affected.

Trial ID:

2024-513250-30-00

Protocol code:

P170923J

NCT ID:

NCT06351501

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effectiveness of Hormonal Treatment with Estradiol Hemihydrate and Testosterone in Adolescents with Gender Dysphoria

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