Study of PET Scans and Serotonin in Hot Flashes Treatment
Information source: Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hot Flashes
Intervention: Paroxetine controlled-release (Drug); Conjugated equine estrogen (Drug)
Phase: N/A
Status: Terminated
Sponsored by: Sidney Kimmel Comprehensive Cancer Center Official(s) and/or principal investigator(s): Vered Stearns, MD, Principal Investigator, Affiliation: Johns Hopkins University
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).
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: To estimate the proportion of women who have a 50% or greater reduction in frequency of hot flashes following 4 weeks of paroxetine or conjugated equine estrogen.To evaluate baseline and change in binding of the serotonin transporter in postmenopausal women who suffer hot flashes before and after 4 weeks of paroxetine or conjugated equine estrogen using PET. To correlate baseline and change in binding of the serotonin transporter using PET with reduction of hot flashes after 4 weeks of conjugated equine estrogen or paroxetine.
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 (SSRI/SNRI). Although estrogen
withdrawal is implicated in the initiation of hot flashes, and serotonin's 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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- Postmenopausal women
- 7 or more hot flashes per day for at least 3 months
- Must be able to undergo magnetic resonance (MR) and PET imaging
- Must be able to receive either paroxetine or estrogen
Exclusion Criteria:
- No treatment with hormone therapy or other medications that affect estrogen within
the past 3 months
- No evidence of a currently active cancer
Locations and Contacts
Johns Hopkins University School of Medicine, Baltimore, Maryland 21231, United States
Additional Information
Starting date: October 2005
Last updated: October 1, 2014
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