TranssexualismPhase 4NCT01065220
Sex Steroids and the Serotonin Transporter
A Phase 4 study testing Testolactone undecanoate, Lynestrenol and Cyproterone Acetate in people with Transsexualism, run by Medical University of Vienna at 1 site in Austria.
Trial summary
The aim of this study is to prove the influence of the sex steroid hormones estrogen, progesterone and testosterone on the serotonin transporter (5-HTT) binding using positron emission tomography (PET) and the selective radioligand [11C]DASB. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Transsexualism
- What is being tested?
- Testolactone undecanoate, Lynestrenol and Cyproterone Acetate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteAustria
- Study dates
- Feb 2010to Jan 2014
- Phase
- Phase 4
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- somatic health
- no previous sex hormone medication
- willingness to sign the written informed consent
Who cannot join
- severe diseases
- steroid hormone treatment within 6 months prior inclusion
- treatment with psychotropic agents such as selective serotonin reuptake inhibitors (SSRIs)
- any implant or stainless steel graft
- positive urine pregnancy test in women at the screening visit at each PET day
Trial locations and contacts
1 site in 1 country.
Austria1 site
Department of Psychiatry and Psychotherapy, Medical University of Vienna
Vienna, A-1090
About this study
Official title: The Influence of Sex Steroid Hormones on Serotonin Transporter Binding in the Human Brain Investigated by Positron Emission Tomography
The aim of this study is to prove the influence of the sex steroid hormones estrogen, progesterone and testosterone on the serotonin transporter (5-HTT) binding using positron emission tomography (PET) and the selective radioligand [11C]DASB. Specifically, the 5-HTT binding will be quantified before and after hormone therapy underwent by 10 male-to-female (MtF) and 10 female-to-male (FtM) transsexuals urging for hormone treatment. The high-level, long-term administration of opsite sex steroid hormones in transsexuals provide the unique opportunity to investigate the influence of sex steroid hormones on the serotonergic system. Since the serotonin transporter serves as a primary target molecule for antidepressant treatment, the results of the study will be of benefit for the assessment of the clinical relevance of estrogen and testosterone as modulatory and neuroactive agents.
- Conditions
- Transsexualism
- Being tested
- Testolactone undecanoate, Lynestrenol, Cyproterone Acetate, Estradiol, 5-alpha reductase inhibitor
- Keywords
- Serotonin Transporter, Hormone therapy, Gender Dysphoria, Transsexualism
- Medical subject headings
- Transsexualism, Gender Dysphoria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Testolactone undecanoateDrug
Also called Nebido®
4ml i.m.
LynestrenolDrug
Also called Orgametril®
2/day
Cyproterone AcetateDrug
Also called Androcur®
50mg per day
EstradiolDrug
Also called Estradot®
100 microgram TTS twice a week
5-alpha reductase inhibitorDrug
Also called Finasterid®
1mg daily
| Study group | Role | What they receive |
|---|---|---|
| hormone treatment for MtF | Experimental | * cyproterone acetate
* estradiol
* alpha-5-reductase-inhibitor Receives: Drug: Cyproterone Acetate; Drug: Estradiol; Drug: 5-alpha reductase inhibitor |
| hormone treatment for FtM | Experimental | * testosterone undecanoate
* lynestrenol Receives: Drug: Testolactone undecanoate; Drug: Lynestrenol |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in serotonin-transporter binding potential (BP) in predefined brain regions, measured by Positron Emission Tomography
The serotonin-transporter BP will be assessed in a 90 min. dynamic PET measurement session at three timepoints: before start of hormonal therapy, after four weeks of hormonal therapy, and after 4 months of hormonal therapy
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2010 (estimated)
- Study startFeb 2010
- Primary completionJan 2014
- Study completionJan 2014
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.
- More trials run by Medical University of ViennaThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rupert Lanzenberger, Medical University of Vienna
- Investigators
- Rupert Lanzenberger, MD A/Prof, Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01065220
- Sponsor's protocol ID
- AP13214ONB
- Status last verified
- Jan 2014
- First submitted
- 8 Feb 2010
- Last updated
- 3 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kranz GS, Wadsak W, Kaufmann U, Savli M, Baldinger P, Gryglewski G, Haeusler D, Spies M, Mitterhauser M, Kasper S, Lanzenberger R. High-Dose Testosterone Treatment Increases Serotonin Transporter Binding in Transgender People. Biol Psychiatry. 2015 Oct 15;78(8):525-33. doi: 10.1016/j.biopsych.2014.09.010. Epub 2014 Sep 23.
PubMed 25497691
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Sex Steroid Hormones on Serotonin Transporter Binding in the Human Brain Investigated by Positron Emission Tomography
- ClinicalTrials.gov ID
- NCT01065220
- Acronym / sponsor ID
- AP13214ONB
- Conditions
- Transsexualism
- Keywords
- Serotonin Transporter, Hormone therapy, Gender Dysphoria, Transsexualism
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 9 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 aim of this study is to prove the influence of the sex steroid hormones estrogen, progesterone and testosterone on the serotonin transporter (5-HTT) binding using positron emission tomography (PET) and the selective radioligand [11C]DASB. Specifically, the 5-HTT binding will be quantified before and after hormone therapy underwent by 10 male-to-female (MtF) and 10 female-to-male (FtM) transsexuals urging for hormone treatment. The high-level, long-term administration of opsite sex steroid hormones in transsexuals provide the unique opportunity to investigate the influence of sex steroid hormones on the serotonergic system. Since the serotonin transporter serves as a primary target molecule for antidepressant treatment, the results of the study will be of benefit for the assessment of the clinical relevance of estrogen and testosterone as modulatory and neuroactive agents.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hormone treatment for MtF | Experimental | Drug: Cyproterone Acetate, Drug: Estradiol, Drug: 5-alpha reductase inhibitor* cyproterone acetate * estradiol * alpha-5-reductase-inhibitor |
| hormone treatment for FtM | Experimental | Drug: Testolactone undecanoate, Drug: Lynestrenol* testosterone undecanoate * lynestrenol |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- somatic health
- no previous sex hormone medication
- willingness to sign the written informed consent
Key exclusion criteria (5 listed)
- severe diseases
- steroid hormone treatment within 6 months prior inclusion
- treatment with psychotropic agents such as selective serotonin reuptake inhibitors (SSRIs)
- any implant or stainless steel graft
- positive urine pregnancy test in women at the screening visit at each PET day
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 |
|---|---|---|
| Testolactone undecanoateAlso: Nebido®4ml i.m. | Drug | hormone treatment for FtM |
| LynestrenolAlso: Orgametril®2/day | Drug | hormone treatment for FtM |
| Cyproterone AcetateAlso: Androcur®50mg per day | Drug | hormone treatment for MtF |
| EstradiolAlso: Estradot®100 microgram TTS twice a week | Drug | hormone treatment for MtF |
| 5-alpha reductase inhibitorAlso: Finasterid®1mg daily | Drug | hormone treatment for MtF |
Primary outcome
change in serotonin-transporter binding potential (BP) in predefined brain regions, measured by Positron Emission Tomography
Time frame: 5 months
The serotonin-transporter BP will be assessed in a 90 min. dynamic PET measurement session at three timepoints: before start of hormonal therapy, after four weeks of hormonal therapy, and after 4 months of hormonal therapy
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 3 Jan 2014.
- Derived from this study: PubMed 25497691Kranz GS, Wadsak W, Kaufmann U, Savli M, Baldinger P, Gryglewski G, Haeusler D, Spies M, Mitterhauser M, Kasper S, Lanzenberger R. High-Dose Testosterone Treatment Increases Serotonin Transporter Binding in Transgender People. Biol Psychiatry. 2015 Oct 15;78(8):525-33. doi: 10.1016/j.biopsych.2014.09.010. Epub 2014 Sep 23.
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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.
Rupert Lanzenberger, MD A/Prof principal investigator
Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Testolactone undecanoate, Lynestrenol and Cyproterone Acetate in people with Transsexualism, run by Medical University of Vienna 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 3 inclusion and 5 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 3 Jan 2014. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
change in serotonin-transporter binding potential (BP) in predefined brain regions, measured by Positron Emission Tomography (time frame: 5 months). 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 NCT01065220, 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 3 Jan 2014.