Study of PET Scans and Serotonin in Hot Flashes Treatment

Not Applicable

Terminated

• Conditions: Hot Flashes
• Interventions: Drug: Conjugated equine estrogen; Drug: Paroxetine controlled-release

• Registration Number: NCT00249847
• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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 (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.

Study Timeline

• Study Start: 2005-10
• Study First Submitted: 2005-11-04
• Study First Submitted QC: 2005-11-04
• Study First Posted: 2005-11-07
• Primary Completion: 2007-07
• Study Completion: 2008-04
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-01
• Last Update Posted: 2014-10-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 5

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conjugated equine estrogen	Conjugated equine estrogen	Conjugated equine estrogen (0.625 mg tablet, orally, every day for 4 weeks)
Paroxetine	Paroxetine controlled-release	Paroxetine controlled-release (2-12.5 mg tablets, orally, every day for 4 weeks)

Primary Outcome Measures

Name	Time	Method
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.	Following 4 weeks of study medication
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.	Following 4 weeks of study medication
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.	Following 4 weeks of study medication

Trial Locations

Locations (1)

Johns Hopkins University School of Medicine; 🇺🇸 Baltimore, Maryland, United States