Viewing Study NCT00249847



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Last Modification Date: 2024-10-26 @ 9:20 AM
Study NCT ID: NCT00249847
Status: TERMINATED
Last Update Posted: 2014-10-02
First Post: 2005-11-04

Brief Title: Study of PET Scans and Serotonin in Hot Flashes Treatment
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Organization: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study Overview

Official Title: A Feasibility Study of Positron Emission Tomography PET of the Serotonin Transporter SERT Before and After Treatment With Conjugated Equine Estrogen or Paroxetine for Hot Flashes
Status: TERMINATED
Status Verified Date: 2014-10
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Unable to complete accrual elected to close the study in April 2008
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The purpose of this study is to determine in a preliminary manner whether successful therapy of hot flashes can be associated with changes in the serotonin transporter in the brain The serotonin transporter is important in delivering serotonin into certain portions of the brains serotonin is a chemical that is important in the control of body temperature mood sleep and other functions
Detailed Description: Hot flashes represent the most common complaint among peri- and postmenopausal women Over 60 of postmenopausal women experience hot flashes and 10-20 of all postmenopausal women find them nearly intolerable Despite the prevalence of hot flashes their pathophysiology is not well understood Treatment options include non-pharmacological approaches hormonal interventions and non-hormonal pharmacological agents The most effective treatment for hot flashes is estrogen The most promising non-hormonal treatments for hot flashes are selective serotonin or noradrenergic reuptake inhibitors SSRISNRI Although estrogen withdrawal is implicated in the initiation of hot flashes and serotonins role is well established in thermoregulation the relationship between estrogen and serotonin is not known Preclinical studies suggest that both estrogen and SSRI down regulate the serotonin transporter Clinical studies that further delineate the relationship between effective treatments for hot flashes and the serotonin transporter may shed a new light into the pathophysiology of these symptoms and more importantly into design of new-targeted treatments

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None