NCT06487754

Brief Summary

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.

Trial Health

57
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Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2024

Geographic Reach
1 country

1 active site

Status
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

June 19, 2024

Completed
16 days until next milestone

First Posted

Study publicly available on registry

July 5, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

September 27, 2024

Completed
4 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

December 17, 2024

Status Verified

December 1, 2024

Enrollment Period

4 months

First QC Date

June 19, 2024

Last Update Submit

December 12, 2024

Conditions

Transgender PersonsPelvic PainTestosteroneGender-Affirming Care

Outcome Measures

Primary Outcomes (1)

  • Pelvic pain and impact on quality of life description

    Verbatim from the semi structured interviews

    1.5 hours during semi structured interviews

Secondary Outcomes (1)

  • pelvic pain intensity at the time of the interview

    at the beginning of the interview

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Gender Eligibility Detailstrans masculine individual
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UGA

Saint-Martin-d'Hères, 38100, France

RECRUITING

MeSH Terms

Conditions

Pelvic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

SaraEve Graham Longsworth, MSc

CONTACT

+33646820783

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 19, 2024

First Posted

July 5, 2024

Study Start

September 27, 2024

Primary Completion

February 1, 2025

Study Completion

December 1, 2025

Last Updated

December 17, 2024

Record last verified: 2024-12

Locations

FR(1)