Sex Steroids and the Serotonin Transporter
This study is currently recruiting participants.
Verified January 2013 by Medical University of Vienna
Sponsor:
Medical University of Vienna
Information provided by (Responsible Party):
Rupert Lanzenberger, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01065220
First received: February 8, 2010
Last updated: January 24, 2013
Last verified: January 2013
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Received Date ICMJE | February 8, 2010 | ||||||||
| Last Updated Date | January 24, 2013 | ||||||||
| Start Date ICMJE | February 2010 | ||||||||
| Estimated Primary Completion Date | August 2013 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
change in serotonin-transporter binding potential (BP) in predefined brain regions, measured by Positron Emission Tomography [ Time Frame: 5 months ] [ Designated as safety issue: No ] 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 |
||||||||
| Original Primary Outcome Measures ICMJE |
serotonin-transporter binding potential [ Time Frame: 18 months ] [ Designated as safety issue: No ] | ||||||||
| Change History | Complete list of historical versions of study NCT01065220 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Sex Steroids and the Serotonin Transporter | ||||||||
| Official Title ICMJE | The Influence of Sex Steroid Hormones on Serotonin Transporter Binding in the Human Brain Investigated by Positron Emission Tomography | ||||||||
| Brief 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. 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. |
||||||||
| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 4 | ||||||||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Basic Science |
||||||||
| Condition ICMJE | Transsexualism | ||||||||
| Intervention ICMJE |
|
||||||||
| Study Arm (s) |
|
||||||||
| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 20 | ||||||||
| Estimated Completion Date | September 2013 | ||||||||
| Estimated Primary Completion Date | August 2013 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||||||
| Gender | Both | ||||||||
| Ages | 18 Years to 50 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
|
||||||||
| Location Countries ICMJE | Austria | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01065220 | ||||||||
| Other Study ID Numbers ICMJE | AP13214ONB | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Rupert Lanzenberger, Medical University of Vienna | ||||||||
| Study Sponsor ICMJE | Medical University of Vienna | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
|
||||||||
| Information Provided By | Medical University of Vienna | ||||||||
| Verification Date | January 2013 | ||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||||