Status:
COMPLETED
Gabapentin Versus Estrogen for the Treatment of Hot Flashes
Lead Sponsor:
University of Rochester
Collaborating Sponsors:
National Institutes of Health (NIH)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Hot Flashes
Eligibility:
FEMALE
35-60 years
Phase:
PHASE4
Brief Summary
To compare the efficacy and safety of gabapentin, estrogen and placebo in the treatment of hot flashes and other climacteric symptoms.
Detailed Description
HRT is associated with an increased risk of thrombo-embolic events, breast cancer and cardiovascular events. Safe, effective, and well-tolerated alternative therapies for hot flashes are needed. Gabap...
Eligibility Criteria
Inclusion
- Menopausal women between ages 35-60
- Must experience 7-20, moderate-severe hot flashes/day or 50-140 moderate-severe hot flashes/week for greater than two months
- Must have had a bilateral salpingo-oopherectomy for \>12 months or amenorrhea\>6 months or #4 (below)
- Has an FSH\>30 mIU/ml
- Must have a signed informed consent
- Able to function independent in all activities of daily living and be capable of reliable documentation
Exclusion
- Any contraindication to estrogen and progesterone replacement therapy
- History of an MI, stroke, and/or functional decline.
- Fails to record data in the hot flash diary\>3 days during the 2 week baseline period.
- Unable or willing to make required visits at the specified times over the course of therapy.
- History of any malignancies or undiagnosed vaginal bleeding.
- History of chronic liver, gallbladder, chronic renal, cardiac or endocrine diseases
Key Trial Info
Start Date :
May 1 2002
Trial Type :
INTERVENTIONAL
End Date :
September 1 2004
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00276081
Start Date
May 1 2002
End Date
September 1 2004
Last Update
November 28 2006
Active Locations (1)
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1
University of Rochester
Rochester, New York, United States, 14642