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Gender DysphoriaTransmannNCT03637920

Sexuality in Transmen During Hormone and Operative Treatment

An observational study of Gender Dysphoria and Gender Identity Disorder, run by Medical University of Graz at 1 site in Austria.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 50 years
How many people
160 participants
Where
1 siteAustria
Study dates
30 Jul 2018to 30 Jul 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • No healthy volunteers
  • Adult

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".

Who may be able to join

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

Who cannot join

  • insufficient German
  • patient rejects the participation

Trial locations and contacts

1 site in 1 country.

Daniela Ulrich, Assoc Prof, MD PhD contact

+43(0)316-385-81437

daniela.ulrich@medunigraz.at

Riccarda C Hartleb, MSc contact

riccarda.hartleb@stud.medunigraz.at

Austria1 site, 1 recruiting

  • Medical University Graz

    Graz, Styria, 8010

    Daniela Ulrich, Assoc Prof, MD PhD, +43(0)316-385-81437, daniela.ulrich@medunigraz.at

    Recruiting

Other trials in Austria

About this study

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

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.

Read the 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

Keywords
Transmen, Sexuality, Sexual behavior, Body Image, Trassexualism
Medical subject headings
Gender Dysphoria, Transsexualism, Sexuality, Sexual Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03637920
Study groupRoleWhat they receive
transmenBiological women, who identify as men and are seeking gender reassignment.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 2 years

Secondary outcomes (7)

  1. 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).

    Measured: 5 years

  2. 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.

    Measured: 5 years

  3. 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.

    Measured: 5 years

  4. 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).

    Measured: 5 years

  5. 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).

    Measured: 5 years

  6. 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.

    Measured: 5 years

  7. 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.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Aug 2018
  2. Study start30 Jul 2018
  3. Primary completion30 Jul 2022 (estimated)
  4. Study completion30 Jul 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
160 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03637920
Sponsor's protocol ID
30-087 ex 17/18
Acronym
Transmann
Status last verified
Aug 2018
First submitted
10 Aug 2018
Last updated
20 Aug 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Gender Dysphoria and Gender Identity Disorder, run by Medical University of Graz at 1 site in Austria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 20 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Daniela Ulrich, Assoc Prof, MD PhD (+43(0)316-385-81437, daniela.ulrich@medunigraz.at), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in sexuality due to hormonal treatment using the Multidimensional Sexuality Questionnaire (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03637920.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2018.

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