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Study of PET Scans and Serotonin in Hot Flashes Treatment

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ClinicalTrials.gov Identifier: NCT00249847
Recruitment Status : Terminated (Unable to complete accrual; elected to close the study in April 2008.)
First Posted : November 7, 2005
Last Update Posted : October 2, 2014
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center

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).

Condition or disease Intervention/treatment
Hot Flashes Drug: Paroxetine controlled-release Drug: Conjugated equine estrogen

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : October 2005
Primary Completion Date : July 2007
Study Completion Date : April 2008

Arm Intervention/treatment
Experimental: Paroxetine
Paroxetine controlled-release (2-12.5 mg tablets, orally, every day for 4 weeks)
Drug: Paroxetine controlled-release
2-12.5 mg tablets, orally, every day for 4 weeks
Other Name: Paxil CR
Experimental: Conjugated equine estrogen
Conjugated equine estrogen (0.625 mg tablet, orally, every day for 4 weeks)
Drug: Conjugated equine estrogen
0.625 mg tablet, orally, every day for 4 weeks
Other Name: Premarin

Primary Outcome Measures :
  1. 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. [ Time Frame: Following 4 weeks of study medication ]
  2. 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. [ Time Frame: Following 4 weeks of study medication ]
  3. 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. [ Time Frame: Following 4 weeks of study medication ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00249847

United States, Maryland
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States, 21231
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
Principal Investigator: Vered Stearns, MD Johns Hopkins University

Responsible Party: Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00249847     History of Changes
Other Study ID Numbers: SKCCC J0360
First Posted: November 7, 2005    Key Record Dates
Last Update Posted: October 2, 2014
Last Verified: October 2014

Keywords provided by Sidney Kimmel Comprehensive Cancer Center:
Hot flashes, vasomotor symptoms, estrogen, paroxetine

Additional relevant MeSH terms:
Hot Flashes
Signs and Symptoms
Estrogens, Conjugated (USP)
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Serotonin Receptor Agonists