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New treatment option for Gender Dysphoria
Official title Early Mental Response - The EMRE Study
ClinicalTrials.gov ID: NCT05649605
What this study is testing
What is Testosterone treatment?
Testosterone treatment is an investigational medicine, given as an injection into a muscle, being studied as a potential treatment for gender dysphoria.
Also referred to as Nebido (3-oxandrostenderivate), testosterone undecanoate.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Primary question: Does transgender men's experience of gender incongruence improve within 6 weeks of hormonal treatment compared to placebo? Long before any bodily changes occur.
- Time commitment: about 6 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 99, women only
You may be able to join if
- Well-informed written consent to participate in the study.
- Transgender man given the ICD-10 diagnosis of transsexualism.
- A desire for complete gender-confirming hormonal treatment.
- Approved for Nebido treatment by a clinically responsible Endocrinologist.
You likely can't join if
- A concomitant hormonal condition affecting the gonadal axis (e.g. Congenital Adrenal Hyperplasia, Poly Cystic Ovary Syndrome, Complete Androgen...
- A disability that prevents the patient from fully participating in the study.
- Treatment with steroid hormones (androgens, estrogens, progestogens, or continuous treatment with oral corticosteroids within the last three months).
- Previous use of hormone preparations without a doctor's prescription.
- Laboratory samples significantly outside the normal reference range.
- Anamnestic or investigational suspicion of breast cancer or existing or previous liver tumors.
See the full eligibility criteria
- Well-informed written consent to participate in the study.
- Transgender man given the ICD-10 diagnosis of transsexualism.
- A desire for complete gender-confirming hormonal treatment.
- Approved for Nebido treatment by a clinically responsible Endocrinologist.
- 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...
- A disability that prevents the patient from fully participating in the study.
- Treatment with steroid hormones (androgens, estrogens, progestogens, or continuous treatment with oral corticosteroids within the last three months).
- Previous use of hormone preparations without a doctor's prescription.
- Laboratory samples significantly outside the normal reference range.
- Anamnestic or investigational suspicion of breast cancer or existing or previous liver tumors.
- Levels of P-ASAT, P-ALAT, or P-GT at the screening time that are\> 2 times the reference range.
- Hypersensitivity to the active substance or to any of the excipients.
- Ongoing pregnancy or wishes for a pregnancy in the near future.
The study team makes the final eligibility decision.
Where it's taking place
- Stockholm, Sweden
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 6 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling female, 18 years to 99 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Stockholm, Sweden. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.