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Study of PET Scans and Serotonin in Hot Flashes Treatment

This study has been terminated.
(Unable to complete accrual; elected to close the study in April 2008.)
Sponsor:
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00249847
First received: November 4, 2005
Last updated: October 1, 2014
Last verified: October 2014
  Purpose

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 Intervention
Hot Flashes
Drug: Paroxetine controlled-release
Drug: Conjugated equine estrogen

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Sidney Kimmel Comprehensive Cancer Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 5
Study Start Date: October 2005
Study Completion Date: April 2008
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00249847

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

No publications provided

Responsible Party: Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00249847     History of Changes
Other Study ID Numbers: SKCCC J0360
Study First Received: November 4, 2005
Last Updated: October 1, 2014
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Hot Flashes
Signs and Symptoms
Estrogens
Estrogens, Conjugated (USP)
Paroxetine
Antidepressive Agents
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Uptake Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014