NCT04551144

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 9, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 16, 2020

Completed
20 days until next milestone

Study Start

First participant enrolled

October 6, 2020

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 18, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 18, 2023

Completed
Last Updated

January 8, 2024

Status Verified

January 1, 2024

Enrollment Period

2.3 years

First QC Date

September 9, 2020

Last Update Submit

January 4, 2024

Conditions

Gender IncongruenceTransgenderism

Outcome Measures

Primary Outcomes (1)

  • Androgen receptor

    change in Androgen receptor expression in subcutaneous adipose tissue in transmen

    6 months

Secondary Outcomes (3)

  • Estrogen receptor and aromatase

    6 months

  • inflammation

    6 months

  • autophagy

    6 months

Study Arms (2)

Transmen

Subjects starting testosterone therapy as part of standard of care for gender incongruence

Drug: testosterone cypionate

transwomen

Subjects starting estradiol therapy as part of standard of care for gender incongruence

Drug: Estradiol Valerate

Interventions

testosterone cypionateDRUG

intramuscular injection every 2 weeks. Dose will be titrated based on blood levels

Transmen
Estradiol ValerateDRUG

intramuscular injection every week. Dose will be titrated based on blood levels

transwomen

Eligibility Criteria

Age18 Years - 50 Years
Sexall(Gender-based eligibility)
Gender Eligibility Details2 groups based on gender identity: transowmen and transmen
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • Diagnosed with gender incongruence by a mental health professional and willing to start gender affirming therapy

You may not qualify if:

  • Used hormone therapy in last 6 months,
  • Pregnancy,
  • Planning to have biological children in the next one year,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saint Louis Univeristy

St Louis, Missouri, 63104, United States

Location

MeSH Terms

Conditions

Gender DysphoriaTranssexualism

Interventions

testosterone 17 beta-cypionateEstradiol

Condition Hierarchy (Ancestors)

Sexual Dysfunctions, PsychologicalMental DisordersSexualitySexual BehaviorBehavior

Intervention Hierarchy (Ancestors)

EstrenesEstranesSteroidsFused-Ring CompoundsPolycyclic CompoundsEstradiol CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Sandeep Dhindsa, MD

    St. Louis University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

September 9, 2020

First Posted

September 16, 2020

Study Start

October 6, 2020

Primary Completion

January 18, 2023

Study Completion

January 18, 2023

Last Updated

January 8, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)