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Sexuality in Transmen During Hormone and Operative Treatment (Transmann)

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ClinicalTrials.gov Identifier: NCT03637920
Recruitment Status : Recruiting
First Posted : August 20, 2018
Last Update Posted : August 20, 2018
Sponsor:
Information provided by (Responsible Party):
Medical University of Graz

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
Gender Dysphoria Gender Identity Disorder Transsexualism Body Image Sexuality

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 Type : Observational
Estimated 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 : July 30, 2018
Estimated Primary Completion Date : July 30, 2022
Estimated Study Completion Date : July 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones

Group/Cohort
transmen
Biological women, who identify as men and are seeking gender reassignment.



Primary Outcome Measures :
  1. Changes in sexuality due to hormonal treatment using the Multidimensional Sexuality Questionnaire [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   The study includes persons who were born as women, but identify as men.
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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".

Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03637920


Contacts
Contact: Daniela Ulrich, Assoc Prof, MD PhD +43(0)316-385-81437 daniela.ulrich@medunigraz.at
Contact: Riccarda C Hartleb, MSc riccarda.hartleb@stud.medunigraz.at

Locations
Austria
Medical University Graz Recruiting
Graz, Styria, Austria, 8010
Contact: Daniela Ulrich, Assoc Prof, MD PhD    +43(0)316-385-81437    daniela.ulrich@medunigraz.at   
Sponsors and Collaborators
Medical University of Graz
Investigators
Principal Investigator: Daniela Ulrich, Assoc Prof, MD PhD Medical University of Graz

Responsible Party: Medical University of Graz
ClinicalTrials.gov Identifier: NCT03637920     History of Changes
Other Study ID Numbers: 30-087 ex 17/18
First Posted: August 20, 2018    Key Record Dates
Last Update Posted: August 20, 2018
Last Verified: August 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:
Transmen
Sexuality
Sexual behavior
Body Image
Trassexualism

Additional relevant MeSH terms:
Gender Dysphoria
Sexual Dysfunctions, Psychological
Mental Disorders
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs