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Recruiting NCT06487754

New-onset Chronic Pelvic Pain in Transgender People Using Testosterone Therapy: an Exploratory Qualitative Study.

Observational Transgender Persons Pelvic Pain Testosterone Gender-Affirming Care

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Transgender Persons, Pelvic Pain, Testosterone, Gender-Affirming Care. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

This descriptive qualitative study aim to describe the characteristics of pelvic pain in transgender (trans) individuals using testosterone therapy and the impact on their quality of life. This study also aim to understand the levers and obstacles to consulting a health care professional.

Detailed description

This study ai to accurately describe the chronic pelvic plan (CPP) from which transmasculine people can suffer, as well as their impact on quality of life, and to understand what are the obstacles and levers to the implementation of adapted care.

Method: It is an observational, single-center, qualitative study. 10 to 15 trans individuals using testosterone therapy and having pelvic pain for at least 6 months, and that had appeared or changed since taking testosterone, will undergo a semi-structured interview. They will be recruited through community care associations, mailing lists and flyers.

Results: This is a qualitative study aimed at accurately describing the symptoms of pelvic pain experienced by trans people thus we will do a qualitative analysis. QCAMAPS will be used for the coding step.

Primary outcome measures

  • Pelvic pain and impact on quality of life description [Time frame: 1.5 hours during semi structured interviews]
Secondary outcome measures (1)
  • pelvic pain intensity at the time of the interview [Time frame: at the beginning of the interview]

Eligibility criteria

Inclusion criteria

  • Being a trans masculine individual
  • Taking a gender affirming hormonal therapy (GAHT)
  • living close to Grenoble
  • having pelvic pain that appeared or were modified after taking GAHT

Exclusion criteria

  • Subject under guardianship or subject deprived of liberty Refusal of voice recording

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 1 center
  • UGA — Saint-Martin-d'Hères

Identifiers

NCT: NCT06487754 · 24.01249.000416

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗