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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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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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 trial?

4 criteria

  • 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 trial?

5 criteria

  • 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.
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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.

What is already known about the treatment

  • Estrogen

    Estrogen is typically administered orally or through skin patches and is used in hormone therapy for individuals experiencing gender dysphoria. It is currently recognized in medical literature as a key component in gender-affirming treatment for transgender individuals. The main therapeutic indication is to aid in the development of secondary female sexual characteristics. At the molecular level, estrogen works by binding to estrogen receptors, influencing gene expression and promoting the development of female physical traits. It is classified as a hormone replacement therapy.

  • Testosterone

    Testosterone is usually administered via injections or transdermal patches and is used in hormone therapy for individuals with gender dysphoria. It is well-documented in medical literature as an essential treatment for transgender individuals seeking masculinization. The primary therapeutic indication is to support the development of secondary male sexual characteristics. On a molecular level, testosterone binds to androgen receptors, altering gene expression to promote male physical traits. It is classified under hormone replacement therapy.

Investigated diseases

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 detailsLast updated 2 Oct 2026
Age0-17PhasePhase IIITrial ID2024-513250-30-00Protocol codeP170923JEstimated enrolment60 patientsSponsorAssistance Publique Hopitaux De Paris

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