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Sponsored by: |
Sidney Kimmel Comprehensive Cancer Center |
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Information provided by: | Sidney Kimmel Comprehensive Cancer Center |
ClinicalTrials.gov Identifier: | NCT00249847 |
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 |
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Hot Flashes |
Drug: Paroxetine controlled-release Drug: Conjugated equine estrogen |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Pharmacodynamics Study |
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 |
Estimated Enrollment: | 30 |
Study Start Date: | October 2005 |
Estimated Study Completion Date: | October 2008 |
Estimated Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Maryland | |
Johns Hopkins University School of Medicine | |
Baltimore, Maryland, United States, 21231 |
Principal Investigator: | Vered Stearns, MD | Johns Hopkins University |
Responsible Party: | SKCCC at Johns Hopkins ( Vered Stearns, MD ) |
Study ID Numbers: | SKCCC J0360 |
Study First Received: | November 4, 2005 |
Last Updated: | May 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00249847 |
Health Authority: | United States: Food and Drug Administration |
Hot flashes, vasomotor symptoms, estrogen, paroxetine |
Signs and Symptoms Estrogens, Conjugated (USP) Hot Flashes Paroxetine Serotonin |
Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Estrogens Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Psychotropic Drugs Hormones |
Serotonin Uptake Inhibitors Pharmacologic Actions Serotonin Agents Therapeutic Uses Antidepressive Agents, Second-Generation Central Nervous System Agents Antidepressive Agents |