Study of PET Scans and Serotonin in Hot Flashes Treatment

NCT00249847 | Terminated DMC

• 1 other identifier: SKCCC J0360
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Hot Flashes

Keywords

Hot flashes, vasomotor symptoms, estrogen, paroxetine

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (2)

Paroxetine

EXPERIMENTAL

Paroxetine controlled-release (2-12.5 mg tablets, orally, every day for 4 weeks)

Drug: Paroxetine controlled-release

Conjugated equine estrogen

EXPERIMENTAL

Conjugated equine estrogen (0.625 mg tablet, orally, every day for 4 weeks)

Drug: Conjugated equine estrogen

Interventions

Paroxetine controlled-release DRUG

2-12.5 mg tablets, orally, every day for 4 weeks

Also known as: Paxil CR

Paroxetine

Conjugated equine estrogen DRUG

0.625 mg tablet, orally, every day for 4 weeks

Also known as: Premarin

Conjugated equine estrogen

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Postmenopausal women
• 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

You may not qualify if:

• No treatment with hormone therapy or other medications that affect estrogen within the past 3 months
• No evidence of a currently active cancer

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead

Study Sites (1)

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21231, United States

Location

MeSH Terms

Conditions

Hot Flashes

Interventions

Paroxetine; Estrogens, Conjugated (USP)

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Vered Stearns, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2005
• First Posted: November 7, 2005
• Study Start: October 1, 2005
• Primary Completion: July 1, 2007
• Study Completion: April 1, 2008
• Last Updated: October 2, 2014

Record last verified: 2014-10

Locations

US (1)