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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


N/A
18 Years
N/A
Not Enrolling
Female
Hot Flashes

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Time Frame:

Following 4 weeks of study medication

Safety Issue:

No

Principal Investigator

Vered Stearns, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Johns Hopkins University

Authority:

United States: Food and Drug Administration

Study ID:

SKCCC J0360

NCT ID:

NCT00249847

Start Date:

October 2005

Completion Date:

April 2008

Related Keywords:

  • Hot Flashes
  • Hot flashes, vasomotor symptoms, estrogen, paroxetine
  • Hot Flashes

Name

Location

Johns Hopkins University School of MedicineBaltimore, Maryland  21205