Study of PET Scans and Serotonin in Hot Flashes Treatment

Hot Flashes Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00249847
• Other study ID #: SKCCC J0360
• Status: Terminated
• Phase: N/A
• First received: November 4, 2005
• Last updated: October 1, 2014
• Start date: October 2005
• Est. completion date: April 2008

Study information

• Verified date: October 2014
• Source: Sidney Kimmel Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: April 2008
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Hot Flashes

Intervention

Drug:
• Paroxetine controlled-release
2-12.5 mg tablets, orally, every day for 4 weeks
• Conjugated equine estrogen
0.625 mg tablet, orally, every day for 4 weeks

Locations

Country	Name	City	State
United States	Johns Hopkins University School of Medicine	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Sidney Kimmel Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		Following 4 weeks of study medication	No
Primary	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.		Following 4 weeks of study medication	No
Primary	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.		Following 4 weeks of study medication	No