Physical and Psychological Evaluation of Hormonal Therapy in Transsexual PersonsENIGINCT01072825
A European Network for the Investigation of Gender Incongruence
An observational study of Physical and Psychological Evaluation of Hormonal Therapy in Transsexual Persons, run by University Hospital, Ghent at 4 sites in 4 countries.
Trial summary
The physical and psychological effects of the hormonal treatment of transsexual persons are not sufficiently described. 'Transparency' wants to answer this question in a prospective manner, in a multicenter study to describe these effects. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Physical and Psychological Evaluation of Hormonal Therapy in Transsexual Persons
- What is being tested?
- questionnaires, blood sampling and clinical evaluation
- Type of treatment
- Pill or oral medicine
- How many people
- 125 participants
- Where
- 4 sitesin 4 countries
- Study dates
- 15 Feb 2010to 31 Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: transsexual persons older than 18 years, who are not yet treated with hormonal therapy
Who may be able to join
- Transsexual persons older then 18 years, who are not yet treated with hormonal therapy.
Who cannot join
- -
Trial locations and contacts
4 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
Guy T'Sjoen, MD contact
4 sites in 4 countries
Belgium1 site, 1 recruiting
- Recruiting
Genderteam UZ Gent
Ghent
Guy T'Sjoen, MD, guy.tsjoen@ugent.be
Guy T'Sjoen, MD
Italy1 site, 1 recruiting
- Recruiting
Study site
Florence
Alessandra Fisher, MD
Alessandra Fisher, MD
Netherlands1 site, 1 recruiting
- Recruiting
VU University Medical CenterAmsterdam
Amsterdam
Michael van Trotsenburg, MD, m.vantrotsenburg@vumc.nl
Michael van Trotsenburg, MD
Norway1 site, 1 recruiting
- Recruiting
Rikshospitalet University Hospital, University of Oslo
Oslo
Thomas Schreiner, thomas.schreiner@rikshospitalet.no
Thomas Schreiner, MD
About this study
The physical and psychological effects of the hormonal treatment of transsexual persons are not sufficiently described. 'Transparency' wants to answer this question in a prospective manner, in a multicenter study to describe these effects. The low prevalence of transsexualism was the stimulus to search for European partners for this Protocol. A common standardized hormonal protocol was designed.
- Being tested
- questionnaires, blood sampling, clinical evaluation, Dermatology evaluation, Bone evaluation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnairesOther
a descriptive questionnaire, SF-36, , bone questionnaires, Baecke physical activity questionnaire, voice evaluation
blood samplingBiological
LFT (AST, ALT), CRP, creatinine, glucose, Total Cholesterol, Triglycerides, HDL-CH, LDL-CH, 25OH vitamin D, PSA if> 45 years, Hematocrit, testosterone, sex hormone-binding globulin, free testosterone , oestradiol, prolactin, luteinizing hormone, TSH, androgeengevoeligheids test (CAG RL), oral glucose tolerance test
clinical evaluationOther
height, weight, blood pressure, chestcircumference, waist circumference, grip strength, measuring 2 ° and 4 ° finger, and Ferriman Gallwey score
Dermatology evaluationOther
Evaluation of the hair pattern, using the Leeds acne classification scale, acne scars through ECCA scale (échelle d'évaluation clinique des cicatrices d'acné), androgenetic alopecia, and sebummetrie
Bone evaluationOther
PQCT scanner, BMD assessment
| Study group | Role | What they receive |
|---|---|---|
| transgender people starting hormone treatment | Not described Receives: Other: questionnaires; Biological: blood sampling; Other: clinical evaluation; Other: Dermatology evaluation; Other: Bone evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
physical and psychological effects of the hormonal treatment of transsexual persons
evaluations will be done every 3 months the first year of therapy, every 6 months in the second year, and after sex reassignment surgery annually.
Measured: annually
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2010 (estimated)
- Study start15 Feb 2010
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Physical and Psychological Evaluation of Hormonal Therapy in Transsexual PersonsStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- 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
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guy T'Sjoen, MD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01072825
- Sponsor's protocol ID
- BC-01783 (EC 2009/622)
- Acronym
- ENIGI
- Status last verified
- Sep 2026
- First submitted
- 19 Feb 2010
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Shadid S, Abosi-Appeadu K, De Maertelaere AS, Defreyne J, Veldeman L, Holst JJ, Lapauw B, Vilsboll T, T'Sjoen G. Effects of Gender-Affirming Hormone Therapy on Insulin Sensitivity and Incretin Responses in Transgender People. Diabetes Care. 2020 Feb;43(2):411-417. doi: 10.2337/dc19-1061. Epub 2019 Nov 18.
PubMed 31740479Auer MK, Ebert T, Pietzner M, Defreyne J, Fuss J, Stalla GK, T'Sjoen G. Effects of Sex Hormone Treatment on the Metabolic Syndrome in Transgender Individuals: Focus on Metabolic Cytokines. J Clin Endocrinol Metab. 2018 Feb 1;103(2):790-802. doi: 10.1210/jc.2017-01559.
PubMed 29216353Bultynck C, Pas C, Defreyne J, Cosyns M, den Heijer M, T'Sjoen G. Self-perception of voice in transgender persons during cross-sex hormone therapy. Laryngoscope. 2017 Dec;127(12):2796-2804. doi: 10.1002/lary.26716. Epub 2017 Jul 21.
PubMed 28730692
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A European Network for the Investigation of Gender Incongruence
- ClinicalTrials.gov ID
- NCT01072825
- Acronym / sponsor ID
- ENIGI / BC-01783 (EC 2009/622)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 15 Feb 2010 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 22 Feb 2010 (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.
The physical and psychological effects of the hormonal treatment of transsexual persons are not sufficiently described. 'Transparency' wants to answer this question in a prospective manner, in a multicenter study to describe these effects. The low prevalence of transsexualism was the stimulus to search for European partners for this Protocol. A common standardized hormonal protocol was designed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| transgender people starting hormone treatment | – | Other: questionnaires, Biological: blood sampling, Other: clinical evaluation, Other: Dermatology evaluation, Other: Bone evaluation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- transsexual persons older than 18 years, who are not yet treated with hormonal therapy
Key inclusion criteria (1 listed)
- Transsexual persons older then 18 years, who are not yet treated with hormonal therapy.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| questionnairesa descriptive questionnaire, SF-36, , bone questionnaires, Baecke physical activity questionnaire, voice evaluation | Other | transgender people starting hormone treatment |
| blood samplingLFT (AST, ALT), CRP, creatinine, glucose, Total Cholesterol, Triglycerides, HDL-CH, LDL-CH, 25OH vitamin D, PSA if> 45 years, Hematocrit, testosterone, sex hormone-binding globulin, free testosterone , oestradiol, prolactin, luteinizing hormone, TSH, androgeengevoeligheids test (CAG RL), oral glucose tolerance test | Biological | transgender people starting hormone treatment |
| clinical evaluationheight, weight, blood pressure, chestcircumference, waist circumference, grip strength, measuring 2 ° and 4 ° finger, and Ferriman Gallwey score | Other | transgender people starting hormone treatment |
| Dermatology evaluationEvaluation of the hair pattern, using the Leeds acne classification scale, acne scars through ECCA scale (échelle d'évaluation clinique des cicatrices d'acné), androgenetic alopecia, and sebummetrie | Other | transgender people starting hormone treatment |
| Bone evaluationPQCT scanner, BMD assessment | Other | transgender people starting hormone treatment |
Primary outcome
physical and psychological effects of the hormonal treatment of transsexual persons
Time frame: annually
evaluations will be done every 3 months the first year of therapy, every 6 months in the second year, and after sex reassignment surgery annually.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Derived from this study: PubMed 31740479Shadid S, Abosi-Appeadu K, De Maertelaere AS, Defreyne J, Veldeman L, Holst JJ, Lapauw B, Vilsboll T, T'Sjoen G. Effects of Gender-Affirming Hormone Therapy on Insulin Sensitivity and Incretin Responses in Transgender People. Diabetes Care. 2020 Feb;43(2):411-417. doi: 10.2337/dc19-1061. Epub 2019 Nov 18.
- Derived from this study: PubMed 29216353Auer MK, Ebert T, Pietzner M, Defreyne J, Fuss J, Stalla GK, T'Sjoen G. Effects of Sex Hormone Treatment on the Metabolic Syndrome in Transgender Individuals: Focus on Metabolic Cytokines. J Clin Endocrinol Metab. 2018 Feb 1;103(2):790-802. doi: 10.1210/jc.2017-01559.
- Derived from this study: PubMed 28730692Bultynck C, Pas C, Defreyne J, Cosyns M, den Heijer M, T'Sjoen G. Self-perception of voice in transgender persons during cross-sex hormone therapy. Laryngoscope. 2017 Dec;127(12):2796-2804. doi: 10.1002/lary.26716. Epub 2017 Jul 21.
- website of the University Hospital of GhentLink provided by the sponsor.
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.
Guy T'Sjoen, MD contact
Guy T'Sjoen, MD principal investigator
University Hospital, Ghent
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Physical and Psychological Evaluation of Hormonal Therapy in Transsexual Persons, run by University Hospital, Ghent at 4 sites in 4 countries.
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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Belgium, Italy, Netherlands, Norway. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guy T'Sjoen, MD (guy.tsjoen@ugent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
physical and psychological effects of the hormonal treatment of transsexual persons (time frame: annually). 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 NCT01072825, which also lists 3 linked publications.
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 21 Sep 2026.