Sexuality in Transmen During Hormone and Operative Treatment

Body Image Clinical Trial

— Transmann  

Official title:

Sexuality in Transmen During Hormone and Operative Treatment Compared to Cisgender Women and Men: a Follow-up Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03637920
• Other study ID #: 30-087 ex 17/18
• Status: Recruiting
• Start date: July 30, 2018
• Est. completion date: July 30, 2023

Study information

• Verified date: August 2018
• Source: Medical University of Graz
• Contact: Daniela Ulrich, Assoc Prof, MD PhD
• Phone: +43(0)316-385-81437
• Email: daniela.ulrich[@]medunigraz.at
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: July 30, 2023
• Est. primary completion date: July 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Body Image
• Gender Dysphoria
• Gender Identity Disorder
• Sexuality
• Transsexualism

Locations

Country	Name	City	State
Austria	Medical University Graz	Graz	Styria

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Changes in sexuality due to surgical reassignment 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).	5 years
Secondary	Changes in sexual history due to surgical reassignment using the Fragebogen zur Sexualgeschichte und zum sexuellen Verhalten	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.	5 years
Secondary	Changes in body image during sexual reassignment therapy using the Fragebogen zum Körperbild	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.	5 years
Secondary	Gender dysphoria using the Utrecht Gender Dysphoria Scale	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 years
Secondary	Sexuality in transmen compared to cisgender women and men 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).	5 years
Secondary	Sexual history in transmen compared to cisgender women and men using the Fragebogen zur Sexualgeschichte und zum sexuellen Verhalten	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.	5 years
Secondary	Changes in sexual history due to hormonal treatment using the Fragebogen zur Sexualgeschichte und zum sexuellen Verhalten	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.	2 years