Gabapentin Versus Estrogen for the Treatment of Hot Flashes
A Randomized Trial of Gabapentin, Estrogen and Placebo for the Treatment of Postmenopausal Hot Flashes
2 other identifiers
interventional
60
1 country
1
Brief Summary
To compare the efficacy and safety of gabapentin, estrogen and placebo in the treatment of hot flashes and other climacteric symptoms.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started May 2002
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2004
CompletedFirst Submitted
Initial submission to the registry
January 11, 2006
CompletedFirst Posted
Study publicly available on registry
January 12, 2006
CompletedNovember 28, 2006
January 1, 2006
January 11, 2006
November 27, 2006
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Reduction in hot flash frequency
Secondary Outcomes (3)
Side effects
Effect on climacteric symptoms
Effect on depression
Interventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Rochester
Rochester, New York, 14642, United States
Related Publications (1)
Reddy SY, Warner H, Guttuso T Jr, Messing S, DiGrazio W, Thornburg L, Guzick DS. Gabapentin, estrogen, and placebo for treating hot flushes: a randomized controlled trial. Obstet Gynecol. 2006 Jul;108(1):41-8. doi: 10.1097/01.AOG.0000222383.43913.ed.
PMID: 16816054RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sireesha Y. Reddy, M.D.
University of Rochester
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
January 11, 2006
First Posted
January 12, 2006
Study Start
May 1, 2002
Study Completion
September 1, 2004
Last Updated
November 28, 2006
Record last verified: 2006-01