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
18 Years
N/A
Female
Hot Flashes
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 Medicine | Baltimore, Maryland 21205 |
