- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03637920
Sexuality in Transmen During Hormone and Operative Treatment (Transmann)
Sexuality in Transmen During Hormone and Operative Treatment Compared to Cisgender Women and Men: a Follow-up Study
Study Overview
Status
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
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Daniela Ulrich, Assoc Prof, MD PhD
- Phone Number: +43(0)316-385-81437
- Email: daniela.ulrich@medunigraz.at
Study Contact Backup
- Name: Riccarda C Hartleb, MSc
- Email: riccarda.hartleb@stud.medunigraz.at
Study Locations
-
-
Styria
-
Graz, Styria, Austria, 8010
- Recruiting
- Medical University Graz
-
Contact:
- Daniela Ulrich, Assoc Prof, MD PhD
- Phone Number: +43(0)316-385-81437
- Email: daniela.ulrich@medunigraz.at
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
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".
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
|---|
|
transmen
Biological women, who identify as men and are seeking gender reassignment.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
5 years
|
|
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.
|
5 years
|
|
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.
|
5 years
|
|
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 years
|
|
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).
|
5 years
|
|
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.
|
5 years
|
|
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.
|
2 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Daniela Ulrich, Assoc Prof, MD PhD, Medical University of Graz
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 30-087 ex 17/18
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.