Gabapentin Versus Estrogen for the Treatment of Hot Flashes

• Status: Completed
• Trial end date: 2004-09-01
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Rochester
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); National Institutes of Health (NIH)
• Treatments: Estrogens; Gabapentin; gamma-Aminobutyric Acid

Criteria

Inclusion Criteria:

1. Menopausal women between ages 35-60

2. Must experience 7-20, moderate-severe hot flashes/day or 50-140 moderate-severe hot flashes/week for greater than two months

3. Must have had a bilateral salpingo-oopherectomy for >12 months or amenorrhea>6 months or #4 (below)

4. Has an FSH>30 mIU/ml

5. Must have a signed informed consent

6. Able to function independent in all activities of daily living and be capable of reliable documentation

Exclusion Criteria:

1. Any contraindication to estrogen and progesterone replacement therapy

2. History of an MI, stroke, and/or functional decline.

3. Fails to record data in the hot flash diary>3 days during the 2 week baseline period.

4. Unable or willing to make required visits at the specified times over the course of therapy.

5. History of any malignancies or undiagnosed vaginal bleeding.

6. History of chronic liver, gallbladder, chronic renal, cardiac or endocrine diseases