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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04551144
Other study ID # 31184
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date October 6, 2020
Est. completion date January 18, 2023

Study information

Verified date January 2024
Source St. Louis University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this research is to find out if hormone therapy in transgender subjects' changes hormone receptors in blood, muscle and fat; fat production; muscle production; and inflammation processes.


Description:

Throughout recorded history, some men and women have experienced emotional distress at being physically "trapped" in wrong gender. Gender incongruence refers to the state where one's internal sense of gender differs from the gender assigned at birth. Advances in psychology and in our understanding of human sexuality have permitted the recognition of gender incongruence (also called transgender) as a biological phenomenon. The acceptance by the society has led to an expansion of health care services available to these individuals for supportive treatment. Gender affirming hormone therapy, usually provided by endocrinologists, is pivotal for the transition of these individuals into their desired gender. This therapy typically consists of testosterone or estrogen (male and female sex hormones) to transition into transmen or transwomen, respectively. The hormone treatment results in a "second puberty", wherein biological men receiving estrogen gain fat around hips and thighs, lose muscle and develop breasts. Biological women receiving testosterone lose fat, gain muscle, stop having menses and develop a deeper voice. However, our knowledge of the mechanisms of these hormones at the tissue level in transgender population is lacking. In this study, we plan to evaluate 1. hormone receptors that carry out the action of sex hormones in fat tissue and mononuclear cells (a type of immune cell in blood) following gender affirming therapy. 2. the mechanism that lead to growth or suppression of fat mass or lean mass 3. effect on inflammation (a cardiovascular risk marker) The hormone treatment of gender incongruence is a relatively untested therapy. The treatment is based on extrapolations and assumptions from hormone treatment in hypogonadal (hormone deficient) in cis-gender (same gender, no incongruence) individuals. We expect that our mechanistic studies will initiate an understanding into the actions of transgender therapy at the cellular level.


Recruitment information / eligibility

Status Terminated
Enrollment 4
Est. completion date January 18, 2023
Est. primary completion date January 18, 2023
Accepts healthy volunteers
Gender All
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria: - Diagnosed with gender incongruence by a mental health professional and willing to start gender affirming therapy Exclusion Criteria: - Used hormone therapy in last 6 months, - Pregnancy, - Planning to have biological children in the next one year, - HIV Additional exclusion criteria for transmen: 1) hematocrit >50% for transmen, 2) transmen with allergy to cottonseed oil (component of intramuscular testosterone injection), 3) uncompensated heart failure, 4) renal failure Additional exclusion criteria for transwomen: 1) allergy to castor oil (component of intramuscular estradiol injection), 2) Known or suspected estrogen-dependent neoplasia, 3) Active deep vein thrombosis, pulmonary embolism or a history of these conditions, 4) Active or recent (e.g., within the past year) arterial thromboembolic disease (e.g., stroke, myocardial infarction), 5) Liver enzymes (AST or ALT) >3 times the upper limit of normal, 6) Known or suspected pregnancy

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
testosterone cypionate
intramuscular injection every 2 weeks. Dose will be titrated based on blood levels
Estradiol Valerate
intramuscular injection every week. Dose will be titrated based on blood levels

Locations

Country Name City State
United States Saint Louis Univeristy Saint Louis Missouri

Sponsors (1)

Lead Sponsor Collaborator
St. Louis University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Androgen receptor change in Androgen receptor expression in subcutaneous adipose tissue in transmen 6 months
Secondary Estrogen receptor and aromatase Expression and protein content of estrogen receptor alpha and aromatase in muscle and fat of transmen and transwomen 6 months
Secondary inflammation expression of inflammatory mediators in fat tissue and circulating levels in serum 6 months
Secondary autophagy Assessment of autophagic flux in fat and muscle biopsies 6 months
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