Metabolic Consequences of Cross-sex Hormonal Treatment

NCT ID: NCT04508231

Last Updated: 2020-08-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

98 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-24

Study Completion Date

2021-12-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Retrospective study in a single academic regional transgender referral center. Analyse VAT, body composition and metabolic parameters in non-obese transgender subjects one year after starting gender-affirming hormone therapy and in controls

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Gender Dysphoria

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Hormonal treatment

The University Hospital in Nancy is an academic regional transgender referral center in Lorraine (France) and keeps a register of subjects available from 2004. The register at the time of the present study (February 2020) included 320 subjects who met diagnostic criteria for gender dysphoria and were seen regularly in the out-patient clinic at our department of endocrinology. Our investigation is a part of the regular care of subjects with gender dysphoria.

Gender-affirming hormone therapy

Intervention Type OTHER

Gender-affirming hormone therapy according to the recommendations of the Endocrine Society

Controls

Data for control subjects are retrieved from medical records of healthy non-obese females and males who underwent an initial assessment for gender dysphoria in our department, but not yet receiving hormonal treatment at the time of the present study.

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Gender-affirming hormone therapy

Gender-affirming hormone therapy according to the recommendations of the Endocrine Society

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* age \>= 16 years (Tanner stage IV) and \<= 50 years at the initiation of gender-affirming hormone therapy;
* BMI \< 28 kg/m2 at the initiation of cross-sex hormonal treatment.

Exclusion Criteria

* hormonal contraception
* previous gender-affirming hormonal treatment
* previous gender-affirming surgery
* recognized syndrome or chromosomal defect, known metabolic or inflammatory disease, skeletal dysplasia, or chronic corticosteroid treatment.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Central Hospital, Nancy, France

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

CHRU Nancy

Nancy, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

References

Explore related publications, articles, or registry entries linked to this study.

Larose C, Samhani C, Consolandi P, Feigerlova E. Increase in visceral adipose tissue and altered metabolic profile in transgender men but not in transgender women one year after starting gender-affirming hormonal therapy. Endocrine. 2025 Sep;89(3):901-909. doi: 10.1007/s12020-025-04310-y. Epub 2025 Jun 10.

Reference Type DERIVED
PMID: 40495044 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2020PI157

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Transgender Estradiol Affirming Therapy
NCT05010707 COMPLETED PHASE2