NCT06710496

Brief Summary

The aim of this study is to report histological results of genital organs removed during gender affirmg surgery in transgender people assigned female at birth (AFAB), to increase the knowledge about the long-term effects of gender affirming hormone therapy with testosterone on these organs and to evaluate the incidence of benign and malign gynecological pathology in AFAB transgender people.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

November 26, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 29, 2024

Completed
2 days until next milestone

Study Start

First participant enrolled

December 1, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2025

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

November 29, 2024

Status Verified

September 1, 2024

Enrollment Period

2 months

First QC Date

November 26, 2024

Last Update Submit

November 26, 2024

Conditions

PregnancySmoking BehaviorTestosterone Replacement TherapyDrugsComorbidities and Coexisting ConditionsGynecological SurgeryTransgender MenGender Affirmation SurgeryHormone Replacement TherapyGynecological Disorders

Keywords

transgenderafabhistology

Outcome Measures

Primary Outcomes (1)

  • histological description of genital organs

    6 months

Secondary Outcomes (1)

  • prevalence of malignant and benign gynecological pathology

    6 months

Study Arms (1)

AFAB TG

assigned female at birth transgender people undergoing gender affirming surgery during testosterone therapy

Other: analysis of medical records

Interventions

analysis of medical recordsOTHER

analysis of medical records of the patients

AFAB TG

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

transgender people assigned female at birth undergoing gender affirming surgery with hysterectomy and on testosterone therapy

You may qualify if:

  • gender incongruence diagnosis
  • people assigned female at birth
  • age \>18 years
  • gender affirming surgery with hysterectomy
  • testosterone therapy

You may not qualify if:

  • previous gynecological surgery
  • previous gynecological disorder diagnosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

irccs azienda ospedaliero universitaria di Bologna

Bologna, Emilia-Romagna, 40138, Italy

Location

MeSH Terms

Conditions

SmokingGenital Diseases, Female

Condition Hierarchy (Ancestors)

BehaviorFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Central Study Contacts

Maria Cristina Meriggiola, Associate Professor

CONTACT

+390512144391segreteria.meriggiola@gmail.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Maria Cristina Meriggiola

Study Record Dates

First Submitted

November 26, 2024

First Posted

November 29, 2024

Study Start

December 1, 2024

Primary Completion

February 1, 2025

Study Completion

December 1, 2025

Last Updated

November 29, 2024

Record last verified: 2024-09

Locations

IT(1)