Gender IncongruenceNCT04551144
Effect of Transgender Therapy on Muscle, Fat and Tissue Receptors
An observational study of Gender Incongruence and Transgenderism, run by St. Louis University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Gender Incongruence, Transgenderism
- What is being tested?
- testosterone cypionate and Estradiol Valerate
- Type of treatment
- Injection or infusion
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Oct 2020to 18 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Adult
Study population: We plan to conduct a prospective, open label study in individuals initiating gender affirming therapy for gender incongruence. We will recruit 20 transmen and 20 transwomen in this study.
Who may be able to join
- Diagnosed with gender incongruence by a mental health professional and willing to start gender affirming therapy
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Transgender Therapy on Hormone Receptors, Adipogenesis, Myogenesis and Inflammation
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.
Read the detailed 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
- 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.
- the mechanism that lead to growth or suppression of fat mass or lean mass
- 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.
- Conditions
- Gender Incongruence, Transgenderism
- Being tested
- testosterone cypionate, Estradiol Valerate
- Medical subject headings
- Gender Dysphoria, Transsexualism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
testosterone cypionateDrug
intramuscular injection every 2 weeks. Dose will be titrated based on blood levels
Estradiol ValerateDrug
intramuscular injection every week. Dose will be titrated based on blood levels
| Study group | Role | What they receive |
|---|---|---|
| Transmen | Subjects starting testosterone therapy as part of standard of care for gender incongruence Receives: Drug: testosterone cypionate | |
| transwomen | Subjects starting estradiol therapy as part of standard of care for gender incongruence Receives: Drug: Estradiol Valerate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Androgen receptor
change in Androgen receptor expression in subcutaneous adipose tissue in transmen
Measured: 6 months
Secondary outcomes (3)
Estrogen receptor and aromatase
Expression and protein content of estrogen receptor alpha and aromatase in muscle and fat of transmen and transwomen
Measured: 6 months
inflammation
expression of inflammatory mediators in fat tissue and circulating levels in serum
Measured: 6 months
autophagy
Assessment of autophagic flux in fat and muscle biopsies
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2020
- Study start6 Oct 2020
- Primary completion18 Jan 2023
- Study completion18 Jan 2023
Why it stopped: lack of recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gender IncongruenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Louis University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sandeep Singh Dhindsa, M.D., F.A.C.E, St. Louis University
- Investigators
- Sandeep Dhindsa, MD, Principal investigator, St. Louis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04551144
- Sponsor's protocol ID
- 31184
- Status last verified
- Jan 2024
- First submitted
- 9 Sep 2020
- Last updated
- 8 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Transgender Therapy on Hormone Receptors, Adipogenesis, Myogenesis and Inflammation
- ClinicalTrials.gov ID
- NCT04551144
- Acronym / sponsor ID
- 31184
- Conditions
- Gender Incongruence, Transgenderism
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: lack of recruitment
- Enrolment
- 4 participants (actual)
- Lead sponsor
- St. Louis UniversityUniversity, hospital or other
- Study start
- 6 Oct 2020 (actual)
- Primary completion
- 18 Jan 2023 (actual)
- Study completion
- 18 Jan 2023 (actual)
- First posted
- 16 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
- 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.
- the mechanism that lead to growth or suppression of fat mass or lean mass
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transmen | – | Drug: testosterone cypionateSubjects starting testosterone therapy as part of standard of care for gender incongruence |
| transwomen | – | Drug: Estradiol ValerateSubjects starting estradiol therapy as part of standard of care for gender incongruence |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Age groups
- Adult
- Study population
- We plan to conduct a prospective, open label study in individuals initiating gender affirming therapy for gender incongruence. We will recruit 20 transmen and 20 transwomen in this study.
Key inclusion criteria (1 listed)
- Diagnosed with gender incongruence by a mental health professional and willing to start gender affirming therapy
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| testosterone cypionateintramuscular injection every 2 weeks. Dose will be titrated based on blood levels | Drug | Transmen |
| Estradiol Valerateintramuscular injection every week. Dose will be titrated based on blood levels | Drug | transwomen |
Primary outcome
Androgen receptor
Time frame: 6 months
change in Androgen receptor expression in subcutaneous adipose tissue in transmen
3 secondary outcomes
Estrogen receptor and aromatase
Time frame: 6 months
inflammation
Time frame: 6 months
autophagy
Time frame: 6 months
Results and safety
The study was stopped early (reason given: lack of recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandeep Dhindsa, MD principal investigator
St. Louis University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gender Incongruence and Transgenderism, run by St. Louis University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: lack of recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Androgen receptor (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2024.