NCT03637920

Brief Summary

With this analysis the investigators aim at discovering a difference in sexuality between transmen, cissexual women and cissexual men. A potential impact of body satisfaction will also be explored. Furthermore the investigators want to assess the gender dysphoria in transmen.

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
160

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

July 30, 2018

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

August 10, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 20, 2018

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2023

Completed
Last Updated

August 20, 2018

Status Verified

August 1, 2018

Enrollment Period

4 years

First QC Date

August 10, 2018

Last Update Submit

August 16, 2018

Conditions

Gender DysphoriaGender Identity DisorderTranssexualismBody ImageSexuality

Keywords

TransmenSexualitySexual behaviorBody ImageTrassexualism

Outcome Measures

Primary Outcomes (1)

  • Changes in sexuality due to hormonal treatment using the Multidimensional Sexuality Questionnaire

    The Multidimensional Sexuality Questionnaire (German version: Multidimensionaler Fragebogen zur Sexualität; Brenk-Franz \& Strauß, 2011) assesses 12 different aspects of sexuality and consists of 60 items on a scale from 1 to 5. It also includes one nominal item, which refers to the relationship status. Sum scores are formed for each subscale (high scores indicate high value).

    2 years

Secondary Outcomes (7)

  • Changes in sexuality due to surgical reassignment using the Multidimensional Sexuality Questionnaire

    5 years

  • Changes in sexual history due to surgical reassignment using the Fragebogen zur Sexualgeschichte und zum sexuellen Verhalten

    5 years

  • Changes in body image during sexual reassignment therapy using the Fragebogen zum Körperbild

    5 years

  • Gender dysphoria using the Utrecht Gender Dysphoria Scale

    5 years

  • Sexuality in transmen compared to cisgender women and men using the Multidimensional Sexuality Questionnaire

    5 years

  • +2 more secondary outcomes

Study Arms (1)

transmen

Biological women, who identify as men and are seeking gender reassignment.

Eligibility Criteria

Age18 Years - 50 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsThe study includes persons who were born as women, but identify as men.
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The study includes biological women, who identify as men and are planning to go through gender reassignment. The participants age is between 18 and 50. Participants are recruited at the Medical University Hospital of Graz and the consulting center "Courage".

You may qualify if:

  • Transsexualism (Female to Male) approved by a psychologist's oder psychiatrist's report
  • good German skills
  • fully competent
  • good computer skills

You may not qualify if:

  • insufficient German
  • patient rejects the participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University Graz

Graz, Styria, 8010, Austria

RECRUITING

MeSH Terms

Conditions

Gender DysphoriaTranssexualismSexualitySexual Behavior

Condition Hierarchy (Ancestors)

Sexual Dysfunctions, PsychologicalMental DisordersBehavior

Study Officials

  • Daniela Ulrich, Assoc Prof, MD PhD

    Medical University of Graz

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniela Ulrich, Assoc Prof, MD PhD

CONTACT

+43(0)316-385-81437daniela.ulrich@medunigraz.at

Riccarda C Hartleb, MSc

CONTACT

riccarda.hartleb@stud.medunigraz.at

Study Design

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

Study Record Dates

First Submitted

August 10, 2018

First Posted

August 20, 2018

Study Start

July 30, 2018

Primary Completion

July 30, 2022

Study Completion

July 30, 2023

Last Updated

August 20, 2018

Record last verified: 2018-08

Locations

AU(1)