TranssexualismNCT02185274
Observational Study on Metabolism and Psychopathology in Transsexual Patients
An observational study of Transsexualism, run by Max-Planck-Institute of Psychiatry at 3 sites in Germany.
Trial summary
Gender identity disorders (also known as transsexualism) is defined as a condition in which a person with apparently normal somatic sexual differentiation is convinced that he or she is actually a member of the other sex. Most patients therefore undergo so called cross-sex hormone treatment. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Transsexualism
- How many people
- 100 participants
- Where
- 3 sitesGermany
- Study dates
- Oct 2013to 30 Nov 2019
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients will be recruited from the outpatient clinics of the corresponding centres. Every patient is eligible who has not yet received any cross-sex hormone treatment. Patients will be invited to participate at the regular visit after which it is planned to start hormone treatment. Further visits will follow the regular check-up visits in the corresponding centers.
Who may be able to join
- Patients with the diagnosis gender identity disorder (ICD-10: F64.0), who have given written informed consent following adequate oral and written information.
- General Exclusion criteria
- Patients below the age of 18
- Legally incompetent patients
- Prior intake of cross-sex hormones
- Missing written informed consent
- Intersexuality
Who cannot join
None listed.
Trial locations and contacts
3 sites in 1 country.
Germany3 sites
Gynaecological department of the University hospital of Erlangen
Erlangen, 91054
Institute for Sex Research and Forensic Psychiatry
Hamburg, 20246
Hormon- und Stoffwechselzentrum München
Munich, 80333
About this study
Official title: Observational Study on the Short- and Long-term Effects of Cross-sex-hormone Treatment on Metabolism and Psychopathology in Transsexuals Patients.
Gender identity disorders (also known as transsexualism) is defined as a condition in which a person with apparently normal somatic sexual differentiation is convinced that he or she is actually a member of the other sex. Most patients therefore undergo so called cross-sex hormone treatment. Treatment protocols follow international consensus statements but vary considerably between different centres and countries since no prospective and controlled trials are available on this subject and recommendations are mainly based on retrospective data analysis and experience of the individual centres. Applying high doses of testosterone to biological females and vice versa high doses of estradiol to biological males definitely impacts myriads of body functions, from which it has to be assumed that only a minority has already been elucidated so far. Especially in male-to-female-transsexuals there seems to be an increased risk for the development of mood disorders and cardiometabolic comorbidities. In this multi-center observational study we want to investigate, if there is any difference with regard to these outcomes, according to the varying standards of cross-sex hormone treatment between the different centers. Different outcome measures described below will be assessed each time during routine visits at the different centers.
- Conditions
- Transsexualism
- Keywords
- Transsexualism, Cross-sex hormone treatment, Sex hormones, Mood, Stress, Cortisol, Cardiovascular, Metabolome
- Medical subject headings
- Transsexualism
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of depressive and anxious symptoms following initiation of cross-sex hormone treatment
Incidence of depressive and anxious symptoms by means of clinical interview and questionnaires in the the study period defined by different cut-off points in the point scales of the corresponding questionnaire (Beck Depression Inventory II = BDII and Symptomcheckliste bei psychischen Störungen = SCL90 for depression and State and Trait Anxiety Inventory = STAI-X1, X2 for anxiety). A comparison will then be done between the different treatment modes.
Measured: Up to 5 years
Differences in the effects of the different treatment types on cardiometabolic parameters
Differences in the effects of the different treatment types (differing in dose, application route and type of antiandrogen used) on cardiometabolic risk-parameters such as BMI, body-composition, fasting Insulin, fasting glucose, triglycerides, cholesterol, intima media thickness.
Measured: Up to 5 years
Secondary outcomes (7)
Effects of cross-sex hormone treatment on cortisol secretion by hair cortisol measurements
Assessment of cortisol secretion by a hair sample which provides information about the mean cortisol secretion during the last months. One cm of scalp hair resembles approximately 1 month of growth. This may provide additional information concerning overall cortisol secretion during the last 3 months. One small hair will be sampled by scalp and this will be analysed in regard to psychological and metabolic profiles.
Measured: Up to 5 years
Effects of cross-sex hormone treatment on stress-response by means of Dex/CRH-testing
The Dex/CRH-Test has been in use for several years for testing the physiological cortisol-response in psychiatric and neurologic patients and is performed on a routine basis in the Max-Planck Institute for Psychiatry in patients suffering from depressive disorders. It is assumed that regulation of cortisol secretion and responsiveness of the hypothalamus-pituitary-adrenal (HPA)-axis is pathophysiologically related to depression. The test has been proven to be save. Common transient side-effects include flushing, palpitation, tachypnoea and feeling of warmth which usually resolve within minutes without further intervention.
Measured: Up to 5 years
Genetic predictors for treatment response
Predictive value of different polymorphism in genes such as the ERa, ERb and AR (Androgen Receptor), GR (Glucocorticoid-Receptor) or genes involved in steroid metabolism and function on metabolic profiles, breast development and psychiatric outcome.
Measured: Up to 5 years
Effects of cross-sex hormone treatment on the metabolome
Differences in plasma and urine metabolome in plasma such as amino acids; carbohydrates and related; catecholamines and related; complex lipids and related; energy metabolism and organic acids; fatty acids (free and from lipids); purines, pyrimidines and related; steroids and related; vitamins, cofactors and related.
Measured: Up to 5 years
Effects of cross-sex hormone treatment on peripheral neurotrophins
Effects of cross-sex hormone treatment on serum Brain-Derived Neurotrophic Factor (BDNF) levels will be assessed in regular intervals during routine visits.
Measured: Up to 5 years
Association of hair cortisol and cortisol response during dex/crh-testing with psychopathology-scores assessed by clinical interview and questionnaires
The following interviews will be used:
- The MINI-PLUS interview assessing DSM axis I disorders [57].
- The SCID-II interview assessing DSM axis II disorders
The following questionaires will be used
- stress coping (SVF-78)
Personality:
- personality (EPQ, TPQ,NEO-FFI)
- self-reported quality of life (SF-36)
- subjective body experience (FBeK)
- self concept (SKI)
- social support (B-Lor, FSOZ-U)
- early life trauma (CTQ)
Psychopathology:
- State-Trait Anxiety Inventory (STAI Form X1, STAI Form X2)
- Depressive symptoms (BDI II)
- Psychopathology in general (SCL-90)
Associations of cortisol- and ACTH response following dex/crg-challenge will be analyzed with regard to the presence of depression assessed by clinical interview and psychopathology scores assessed by BDI and STAIX. The other questionnaires will be used for multidimensional modelling.
Measured: Up to 5 years
Predictive value of hair cortisol and cortisol response in dex/crh-testing treatment for depression and anxiety
Predictive value of hair cortisol 3 month at baseline and after treatment initiation and cortisol response at baseline and after 3 month after treatment initiation during dex/crh-testing for 12 month incidence of depressive or anxiety disorders assessed by clinical interview and questionnaires.
The following interviews will be used:
- The MINI-PLUS interview assessing DSM axis I disorders [57].
- The SCID-II interview assessing DSM axis II disorders
The following questionaires will be used
- State-Trait Anxiety Inventory (STAI Form X1, STAI Form X2)
- Depressive symptoms (BDI II)
- Psychopathology in general (SCL-90)
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2014 (estimated)
- Study startOct 2013
- Primary completion31 Oct 2019
- Study completion30 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TranssexualismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Max-Planck-Institute of Psychiatry
- Sponsor type
- University, hospital or other
- Collaborators
- University of Erlangen-Nürnberg Medical School, Institute for Sex Research and Forensic Psychiatry, Hamburg, Germany, Hormon-und Stoffwechselzentrum München, Munich, Germany
- Responsible party
- Sponsor
- Investigators
- Matthias K Auer, MD, Principal investigator, Max Planck Insitute of Psychiatry, Department of Neuroendocrinology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02185274
- Sponsor's protocol ID
- MPIP-ENDO1
- Status last verified
- Feb 2020
- First submitted
- 18 Jun 2014
- Last updated
- 25 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Liwinski T, Auer MK, Schroder J, Pieknik I, Casar C, Schwinge D, Henze L, Stalla GK, Lang UE, von Klitzing A, Briken P, Hildebrandt T, Desbuleux JC, Biedermann SV, Holterhus PM, Bang C, Schramm C, Fuss J. Gender-affirming hormonal therapy induces a gender-concordant fecal metagenome transition in transgender individuals. BMC Med. 2024 Sep 2;22(1):346. doi: 10.1186/s12916-024-03548-z.
PubMed 39218875
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study on the Short- and Long-term Effects of Cross-sex-hormone Treatment on Metabolism and Psychopathology in Transsexuals Patients.
- ClinicalTrials.gov ID
- NCT02185274
- Acronym / sponsor ID
- MPIP-ENDO1
- Conditions
- Transsexualism
- Keywords
- Transsexualism, Cross-sex hormone treatment, Sex hormones, Mood, Stress, Cortisol, Cardiovascular, Metabolome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Max-Planck-Institute of PsychiatryUniversity, hospital or other
- Collaborators
- University of Erlangen-Nürnberg Medical School, Institute for Sex Research and Forensic Psychiatry, Hamburg, Germany, Hormon-und Stoffwechselzentrum München, Munich, Germany
- Study start
- Oct 2013
- Primary completion
- 31 Oct 2019 (actual)
- Study completion
- 30 Nov 2019 (actual)
- First posted
- 9 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Gender identity disorders (also known as transsexualism) is defined as a condition in which a person with apparently normal somatic sexual differentiation is convinced that he or she is actually a member of the other sex. Most patients therefore undergo so called cross-sex hormone treatment. Treatment protocols follow international consensus statements but vary considerably between different centres and countries since no prospective and controlled trials are available on this subject and recommendations are mainly based on retrospective data analysis and experience of the individual centres. Applying high doses of testosterone to biological females and vice versa high doses of estradiol to biological males definitely impacts myriads of body functions, from which it has to be assumed that only a minority has already been elucidated so far. Especially in male-to-female-transsexuals there seems to be an increased risk for the development of mood disorders and cardiometabolic comorbidities. In this multi-center observational study we want to investigate, if there is any difference with regard to these outcomes, according to the varying standards of cross-sex hormone treatment between the different centers. Different outcome measures described below will be assessed each time during routine visits at the different centers.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be recruited from the outpatient clinics of the corresponding centres. Every patient is eligible who has not yet received any cross-sex hormone treatment. Patients will be invited to participate at the regular visit after which it is planned to start hormone treatment. Further visits will follow the regular check-up visits in the corresponding centers.
Key inclusion criteria (7 listed)
- Patients with the diagnosis gender identity disorder (ICD-10: F64.0), who have given written informed consent following adequate oral and written information.
- General Exclusion criteria
- Patients below the age of 18
- Legally incompetent patients
- Prior intake of cross-sex hormones
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of depressive and anxious symptoms following initiation of cross-sex hormone treatment
Time frame: Up to 5 years
Incidence of depressive and anxious symptoms by means of clinical interview and questionnaires in the the study period defined by different cut-off points in the point scales of the corresponding questionnaire (Beck Depression Inventory II = BDII and Symptomcheckliste bei psychischen Störungen = SCL90 for depression and State and Trait Anxiety Inventory = STAI-X1, X2 for anxiety). A comparison will then be done between the different treatment modes.
Differences in the effects of the different treatment types on cardiometabolic parameters
Time frame: Up to 5 years
Differences in the effects of the different treatment types (differing in dose, application route and type of antiandrogen used) on cardiometabolic risk-parameters such as BMI, body-composition, fasting Insulin, fasting glucose, triglycerides, cholesterol, intima media thickness.
7 secondary outcomes
Effects of cross-sex hormone treatment on cortisol secretion by hair cortisol measurements
Time frame: Up to 5 years
Effects of cross-sex hormone treatment on stress-response by means of Dex/CRH-testing
Time frame: Up to 5 years
Genetic predictors for treatment response
Time frame: Up to 5 years
Effects of cross-sex hormone treatment on the metabolome
Time frame: Up to 5 years
Effects of cross-sex hormone treatment on peripheral neurotrophins
Time frame: Up to 5 years
Association of hair cortisol and cortisol response during dex/crh-testing with psychopathology-scores assessed by clinical interview and questionnaires
Time frame: Up to 5 years
Predictive value of hair cortisol and cortisol response in dex/crh-testing treatment for depression and anxiety
Time frame: Up to 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2020.
- Derived from this study: PubMed 39218875Liwinski T, Auer MK, Schroder J, Pieknik I, Casar C, Schwinge D, Henze L, Stalla GK, Lang UE, von Klitzing A, Briken P, Hildebrandt T, Desbuleux JC, Biedermann SV, Holterhus PM, Bang C, Schramm C, Fuss J. Gender-affirming hormonal therapy induces a gender-concordant fecal metagenome transition in transgender individuals. BMC Med. 2024 Sep 2;22(1):346. doi: 10.1186/s12916-024-03548-z.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthias K Auer, MD principal investigator
Max Planck Insitute of Psychiatry, Department of Neuroendocrinology
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Transsexualism, run by Max-Planck-Institute of Psychiatry at 3 sites in Germany.
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 7 inclusion and 0 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: finished, as of the sponsor's last update on 25 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of depressive and anxious symptoms following initiation of cross-sex hormone treatment (time frame: Up to 5 years). The study lists 2 primary outcomes in all. 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 NCT02185274, which also lists 1 linked publication.
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 25 Feb 2020.