Gabapentin Versus Estrogen for the Treatment of Hot Flashes

Completed · Phase 4 · Has a placebo group

Conditions studied: Hot Flashes

In brief

To compare the efficacy and safety of gabapentin, estrogen and placebo in the treatment of hot flashes and other climacteric symptoms.

Key facts

Study ID

NCT00276081

Run by

University of Rochester

People needed

60

Starts

2002-05-01

Expected to finish

2004-09-01

Last updated by the study team

2006-11-28

Who can join

Age: 35 and older, up to 60. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Rochester — Rochester, New York, United States

Full record on ClinicalTrials.gov

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