Early Mental Response - The EMRE Study

NCT05649605 | Recruiting DMC

• 1 other identifier: 2019-004349-34 SE
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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. Secondary question: Does transgender men´s experience of self-esteem, quality of life, sexual desire, aggression, depression/anxiety, impulsiveness, and emotional reactivity improve during 6 weeks of cross-sex hormone therapy compared to placebo? Gender dysphoria is a condition characterized by a perceived incongruence between the body and identity. For several decades this condition has been treated with cross-sex hormone therapy and surgery, among others, in order to change the body to be more congruent with the perceived gender identity. Patient satisfaction with this treatment is very high where an overwhelming majority of patients live the rest of their lives according to their perceived gender. A clinical observation, however, is that most patients experience that the congruence between the perceived gender and the assigned one improves very quickly on hormonal treatment. Long before any changes to the body have taken place. This may be partly due to relief from having finally started treatment (i.e. a psychological/social explanation) but an alternative (and much more likely) explanation is that the hormonal treatment directly affects the brain. Since the cause of gender dysphoria is unknown today, this study is therefore a step in trying to clarify the mechanism. In addition, it is of value to be able to demonstrate the benefits of hormonal treatment in these patients. Finally, there is a basic research motive for this study. The effect of sex hormones on the brain is very well known from a clinical perspective but all the more unknown from a research perspective. This study will contribute knowledge in this area.

Conditions

Gender Dysphoria; Gender Identity; Gender Issues

Outcome Measures

Primary Outcomes (1)

• Changes in baseline gender incongruence at 2 and 6 weeks respectively

  Score according to Transgender Congruence Scale. The total score ranges from a mean value of 12 items scored from 1 to 5. The mean value ranges from 1 to 5 points in total. A low score indicates a high level of gender dysphoria and a high score indicates a low level of gender dysphoria.

  Performed at visit 2 (pre treatment), 2 weeks into treatment (performed at distance) and after 6 weeks of treatment (visit 3, study ends).

Secondary Outcomes (7)

• Changes in baseline slef-esteem at 2 and 6 weeks respectively.

  Performed at visit 2 (pre treatment), 2 weeks into treatment (performed at distance) and after 6 weeks of treatment (visit 3, study ends).

• Changes in baseline quality of life at 2 and 6 weeks respectively.

  Performed at visit 2 (pre treatment), 2 weeks into treatment (performed at distance) and after 6 weeks of treatment (visit 3, study ends).

• Changes in baseline sexual desire at 2 and 6 weeks respectively.

  Performed at visit 2 (pre treatment), 2 weeks into treatment (performed at distance) and after 6 weeks of treatment (visit 3, study ends).

• Changes in baseline aggression at 2 and 6 weeks respectively.

  Performed at visit 2 (pre treatment), 2 weeks into treatment (performed at distance) and after 6 weeks of treatment (visit 3, study ends).

• Changes in baseline depressive symptoms and anxiety at 2 and 6 weeks respectively.

  Performed at visit 2 (pre treatment), 2 weeks into treatment (performed at distance) and after 6 weeks of treatment (visit 3, study ends).

Study Arms (2)

Active comparator arm

ACTIVE COMPARATOR

Active treatment

Drug: Testosterone treatment

Placebo comparator arm

PLACEBO COMPARATOR

Placebo treatment

Other: Placebo treatment

Interventions

Testosterone treatment DRUG

Cross-sex hormone therapy consisting of intramuscular injection of testosterone undecanoate 250mg/ml. 4ml (total dosage of 1000mg) administered by trained nurse in the gluteal region at visit 1.

Also known as: Nebido (3-oxandrostenderivate), testosterone undecanoate

Active comparator arm

Placebo treatment OTHER

Saline solution. Intramuscular injection of physiological saline solution. 4ml administered by trained nurse in the gluteal region at visit 1.

Also known as: Sodium chloride solution

Placebo comparator arm

Eligibility Criteria

• Age: 18 Years - 99 Years
• Gender Eligibility Details: Transgender males
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 may not qualify if:

• 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.).
• 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.

Sponsors & Collaborators

• Karolinska University Hospital: lead

Study Sites (1)

Karolinska Universitetssjukhuset, ANOVA

Stockholm, 112 52, Sweden

RECRUITING

Related Publications (30)

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MeSH Terms

Conditions

Gender Dysphoria; Sexism

Interventions

testosterone undecanoate; Sodium Chloride

Condition Hierarchy (Ancestors)

Sexual Dysfunctions, Psychological; Mental Disorders; Prejudice; Social Behavior; Behavior; Social Discrimination

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Mats Holmberg, MD. PhD.

  ANOVA Karolinska sjukhuset

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mats Holmberg, MD. PhD.

CONTACT

+46705266365; mats.holmberg.1@ki.se

Anders Hagelin, MD.

CONTACT

+46736265973; anders.hagelin@ki.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All participating research staff will be blinded to the treatment the patient is receiving. The drug and placebo will be labelled by Tamro AB, which will ensure that Nebido and placebo cannot be separated.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Model Details: Prospective, randomized, placebo controlled, double blind study.

Study Record Dates

• First Submitted: November 4, 2022
• First Posted: December 14, 2022
• Study Start: March 7, 2023
• Primary Completion: December 30, 2025
• Study Completion (Estimated): December 30, 2026
• Last Updated: March 8, 2023

Record last verified: 2023-03

Locations

SE (1)