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Sponsors and Collaborators: |
University of Rochester National Institutes of Health (NIH) Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
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Information provided by: | University of Rochester |
ClinicalTrials.gov Identifier: | NCT00276081 |
To compare the efficacy and safety of gabapentin, estrogen and placebo in the treatment of hot flashes and other climacteric symptoms.
Condition | Intervention | Phase |
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Hot Flashes |
Drug: Gabapentin, Estrogen and placebo administration |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized Trial of Gabapentin, Estrogen and Placebo for the Treatment of Postmenopausal Hot Flashes |
Estimated Enrollment: | 60 |
Study Start Date: | May 2002 |
Estimated Study Completion Date: | September 2004 |
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. Gabapentin is a gamma-aminobutyric acid (GABA)-analog that we have reported is associated with a reduction in the frequency of hot flashes in postmenopausal women who were taking gabapentin for other indications. However, it is not known whether the efficacy of gabapentin in the treatment of hot flashes and other menopausal symptoms is comparable to that of estrogen, the gold standard. For this study, 60 subjects are to be recruited and randomized into 3 arms of 20 each (gabapentin, estrogen and placebo).We will perform an analysis of the results after all 60 subjects have been recruited, screened, enrolled and completed the study. The investigators of the study continue to be blinded to the study groups and their randomization. To determine if gabapentin approaches the efficacy of estrogen in the treatment of hot flashes,postmenopausal women between ages 35 and 60 with 7-20 moderate-severe postmenopausal hot flashes/day will be randomized into a double-blinded placebo controlled trial of estrogen, gabapentin and placebo. All patients must meet stringent inclusion and exclusion criteria. Pre- and post-study hot flash diaries, depression and climacteria scales will be collected. Patients are required to undergo physical examination and blood work and to complete a daily hot flash and medication compliance records. Hot flash frequency and composite score for hot flashes will be calculated for the three groups based on the hot flash diary. Side effects, climacteric scale and depression scales will also be used.
Ages Eligible for Study: | 35 Years to 60 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, New York | |
University of Rochester | |
Rochester, New York, United States, 14642 |
Principal Investigator: | Sireesha Y. Reddy, M.D. | University of Rochester |
Study ID Numbers: | RO3 HD042609 NIH/NICHD |
Study First Received: | January 11, 2006 |
Last Updated: | November 27, 2006 |
ClinicalTrials.gov Identifier: | NCT00276081 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Hot flashes postmenopausal climacteric symptoms hormone replacement therapy gabapentin |
Excitatory Amino Acids Neurotransmitter Agents Estrogens Tranquilizing Agents Gabapentin Hormone Antagonists Psychotropic Drugs Hot Flashes Hormones, Hormone Substitutes, and Hormone Antagonists Central Nervous System Depressants |
Calcium Channel Blockers Cardiovascular Agents Antimanic Agents Hormones Signs and Symptoms Calcium, Dietary Anti-Anxiety Agents Analgesics Peripheral Nervous System Agents Anticonvulsants |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Gabapentin Anti-Dyskinesia Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Hot Flashes Psychotropic Drugs Antiparkinson Agents Calcium Channel Blockers Excitatory Amino Acid Agents Hormones Membrane Transport Modulators Signs and Symptoms |
Sensory System Agents Therapeutic Uses Analgesics Excitatory Amino Acid Antagonists Estrogens Tranquilizing Agents Central Nervous System Depressants Cardiovascular Agents Antimanic Agents Pharmacologic Actions Anti-Anxiety Agents Peripheral Nervous System Agents Central Nervous System Agents Anticonvulsants |