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

December 12, 2024 updated by: University Hospital, Grenoble
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.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

15

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: SaraEve Graham Longsworth, MSc
  • Phone Number: +33646820783

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Trans masculine individuals using a gender affirming hormonal therapy (testosterone) and having pelvic pain.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pelvic pain and impact on quality of life description
Time Frame: 1.5 hours during semi structured interviews
Verbatim from the semi structured interviews
1.5 hours during semi structured interviews

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
at the beginning of the interview

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 27, 2024

Primary Completion (Estimated)

February 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

June 19, 2024

First Submitted That Met QC Criteria

June 27, 2024

First Posted (Actual)

July 5, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 12, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24.01249.000416

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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