Hormonal treatment effects on transgender men

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates whether transgender men's experience of gender incongruence improves within six weeks of receiving testosterone treatment compared to a placebo. It also examines the impact of cross-sex hormone therapy on various psychological factors such as self-esteem, quality of life, and emotional reactivity. Participants will receive either testosterone via intramuscular injection or a placebo, with assessments conducted to evaluate changes in their mental health and overall well-being. The study aims to provide insights into the early effects of hormonal treatment before any physical changes occur.

Why it matters

Who can join: the full rules

Inclusion criteria:

1. Well-informed written consent to participate in the study.
2. Transgender man given the ICD-10 diagnosis of transsexualism.
3. A desire for complete gender-confirming hormonal treatment.
4. Approved for Nebido treatment by a clinically responsible Endocrinologist.

Exclusion criteria:

1. A concomitant hormonal condition affecting the gonadal axis (e.g. Congenital Adrenal Hyperplasia, Poly Cystic Ovary Syndrome, Complete Androgen Insensitivity Syndrome, Partial Androgen Insensitivity Syndrome, untreated thyroid disease, untreated hypercortisolism, etc.).
2. A disability that prevents the patient from fully participating in the study.
3. Treatment with steroid hormones (androgens, estrogens, progestogens, or continuous treatment with oral corticosteroids within the last three months).
4. Previous use of hormone preparations without a doctor's prescription.
5. Laboratory samples significantly outside the normal reference range.
6. Anamnestic or investigational suspicion of breast cancer or existing or previous liver tumors.
7. Levels of P-ASAT, P-ALAT, or P-GT at the screening time that are\> 2 times the reference range.
8. Hypersensitivity to the active substance or to any of the excipients.
9. Ongoing pregnancy or wishes for a pregnancy in the near future.

Where it's running

• Karolinska Universitetssjukhuset, ANOVA
  Stockholm, Sweden Recruiting

Study contacts

• Principal investigator: Mats Holmberg, MD. PhD. — ANOVA Karolinska sjukhuset
• Study coordinator: Mats Holmberg, MD. PhD.
• Email: mats.holmberg.1@ki.se
• Phone: +46705266365

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Brain health changes after gender-affirming hormone therapy in transgender adults

  This study tests how starting gender-affirming hormone therapy may affect brain blood flow, structure, connectivity, and cognitive function in transgender adults.

  Recruiting University of Wisconsin, Madison · Madison, Wisconsin · NCT07624747

• Topical estrogen cream to improve recovery for transgender men after hysterectomy

  This study tests if using a special estrogen cream after surgery can help transgender men recover better and feel more comfortable after a hysterectomy.

  Recruiting Phase 3 Women and Infants Hospital of Rhode Island · Providence, Rhode Island · NCT06969326

• Observational study on adults seeking treatment for gender incongruence

  This study is looking to see how well current medical and surgical treatments for gender incongruence work and how satisfied adults are with them, to help improve care for transgender and gender-diverse individuals.

  Recruiting Copenhagen University Hospital, Rigshospitalet · Copenhagen · NCT06953908

• Effects of testosterone on headaches and brain development in transmasculine youth

  This study is testing how testosterone therapy affects headaches and brain development in transmasculine youth aged 12-20 who were assigned female at birth.

  Recruiting University of Colorado, Denver · Aurora, Colorado · NCT06670053

• Evaluating voice outcomes after gender-affirming voice surgeries

  This study is testing how different gender-affirming voice surgeries affect voice quality and patient satisfaction over time.

  Recruiting at 2 sites University Ghent · Ghent, East-Flanders and 1 other locations · NCT06439290

• Evaluating hormonal treatment for adolescents with gender dysphoria

  This study tests if giving cross-sex hormones to teens with gender dysphoria who have started their social transition helps them feel better and function well compared to those who don’t receive the hormones.

  Recruiting at 3 sites Phase 3 Assistance Publique - Hôpitaux de Paris · Paris and 3 other locations · NCT06351501

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.