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NCT Number: NCT06487754

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UGA

Saint-Martin-d'Hères, 38100, France

Location status: Recruiting

Location contact

Blanca Bermudo De Mateo, MSc

CONTACT

[email protected]

Blanca Bermudo De Mateo, MSc

SUB_INVESTIGATOR

Camille Boyer, Student

SUB_INVESTIGATOR

Katia Gheraieb, MSc

SUB_INVESTIGATOR

Max Cressent, Expert

SUB_INVESTIGATOR

SaraEve Graham Longsworth, MSc

CONTACT

[email protected]

+33646820783

SaraEve Graham Longsworth, MSc

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Pelvic pain and impact on quality of life description

    Time frame: 1.5 hours during semi structured interviews

    Verbatim from the semi structured interviews

Secondary outcomes

  1. pelvic pain intensity at the time of the interview

    Time frame: at the beginning of the interview

    visual analog scale from 0 to 100 mm

Study contacts

Contact information is provided by the study sponsor or research team.

SaraEve Graham Longsworth, MSc

CONTACT

+33646820783

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 5, 2024
Registry last updated
Dec 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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