Transmann: Sexuality in Transmen During Hormone and Operative Treatment

Sponsor
Medical University of Graz (Other)
Overall Status
Recruiting
CT.gov ID
NCT03637920
Collaborator
(none)
160
1
60
2.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The aim of the study is to investigate transmen's sexuality and body satisfaction during hormonal and surgical reassignment. Furthermore sexual orientation, sexual behavior and gender dysphoria will be assessed.

    Therefore an online survey with five measurements throughout the gender reassignment treatment is conducted. As a matter of Routine, postoperative complications will be recorded retrospectively. To compare transmen's data with cisgender women and men we will be using data of the questionnaire's validation studies.

    The following questionnaires are used:

    Sexuality: Multidimensionaler Fragebogen zur Sexualität (Brenk-Franz & Strauß, 2011).

    Sexual orientation: Fragebogen zur Sexualgeschichte und zum sexuellen Verhalten (Brenk, 2005) Gender dysphoria: Utrecht Gender Dysphoria Scale (Cohen-Kettenis & Van Goozen, 1997) Body image: Fragebogen zum Körperbild (Clement & Löwe, 1996) Sociodemographic questionnaire: age, education, work, living situation, relationship status, gender reassignment treatment so far, coming out Case report form

    T0: baseline measurement (patient is at the start of the hormonal treatment or has already startet but has not undergone any gender reassignment surgery) T1: within 2 weeks before the mastectomy T2: 6 months (+/- 2 weeks) after mastectomy T3: 6 months (+/- 2 weeks) after colpectomy T4: 6 months (+/- 2 weeks) after the last gender reassignment surgery

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    160 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Sexuality in Transmen During Hormone and Operative Treatment Compared to Cisgender Women and Men: a Follow-up Study
    Actual Study Start Date :
    Jul 30, 2018
    Anticipated Primary Completion Date :
    Jul 30, 2022
    Anticipated Study Completion Date :
    Jul 30, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    transmen

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

    Outcome Measures

    Primary Outcome Measures

    1. Changes in sexuality due to hormonal treatment using the Multidimensional Sexuality Questionnaire [2 years]

      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).

    Secondary Outcome Measures

    1. Changes in sexuality due to surgical reassignment using the Multidimensional Sexuality Questionnaire [5 years]

      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. Changes in sexual history due to surgical reassignment using the Fragebogen zur Sexualgeschichte und zum sexuellen Verhalten [5 years]

      The Fragebogen zur Sexualgeschichte und zum sexuellen Verhalten (Brenk, 2005) is a 16-item scale, with various answer schemes on sexual behavior and sexual history.

    3. Changes in body image during sexual reassignment therapy using the Fragebogen zum Körperbild [5 years]

      Body image will be measured with the Fragebogen zum Körperbild (Clement & Löwe, 1996) including 20 items on a scale of 1-5. 10 Items measure negative body assessment (min. 10, max. 50) and the other 10 items measure vital body dynamic (min. 10, max. 50); sum scores are formed for both scales, in which high scores represent high values in each scale.

    4. Gender dysphoria using the Utrecht Gender Dysphoria Scale [5 years]

      The Utrecht Gender Dysphoria Scale (Cohen-Kettenis & Van Goozen, 1997) is a 12-item questionnaire and is the primary measure used to assess gender dysphoria. Each item is scored on a scale from 1 to 5 and a sum score is calculated with a min. of 12 and a max. of 60 (high sum scores represents a more severe gender dysphoria).

    5. Sexuality in transmen compared to cisgender women and men using the Multidimensional Sexuality Questionnaire [5 years]

      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).

    6. Sexual history in transmen compared to cisgender women and men using the Fragebogen zur Sexualgeschichte und zum sexuellen Verhalten [5 years]

      The Fragebogen zur Sexualgeschichte und zum sexuellen Verhalten (Brenk, 2005) is a 16-item scale, with various answer schemes on sexual behavior and sexual history.

    7. Changes in sexual history due to hormonal treatment using the Fragebogen zur Sexualgeschichte und zum sexuellen Verhalten [2 years]

      The Fragebogen zur Sexualgeschichte und zum sexuellen Verhalten (Brenk, 2005) is a 16-item scale, with various answer schemes on sexual behavior and sexual history.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Transsexualism (Female to Male) approved by a psychologist's oder psychiatrist's report

    • good German skills

    • fully competent

    • good computer skills

    Exclusion Criteria:
    • insufficient German

    • patient rejects the participation

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Medical University Graz Graz Styria Austria 8010

    Sponsors and Collaborators

    • Medical University of Graz

    Investigators

    • Principal Investigator: Daniela Ulrich, Assoc Prof, MD PhD, Medical University of Graz

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Medical University of Graz
    ClinicalTrials.gov Identifier:
    NCT03637920
    Other Study ID Numbers:
    • 30-087 ex 17/18
    First Posted:
    Aug 20, 2018
    Last Update Posted:
    Aug 20, 2018
    Last Verified:
    Aug 1, 2018
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Medical University of Graz
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 20, 2018