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Gabapentin Versus Estrogen for the Treatment of Hot Flashes

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00276081
First Posted: January 12, 2006
Last Update Posted: November 28, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Institutes of Health (NIH)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by:
University of Rochester
  Purpose
To compare the efficacy and safety of gabapentin, estrogen and placebo in the treatment of hot flashes and other climacteric symptoms.

Condition Intervention Phase
Hot Flashes Drug: Gabapentin, Estrogen and placebo administration Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Randomized Trial of Gabapentin, Estrogen and Placebo for the Treatment of Postmenopausal Hot Flashes

Resource links provided by NLM:


Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • Reduction in hot flash frequency

Secondary Outcome Measures:
  • Side effects
  • Effect on climacteric symptoms
  • Effect on depression

Estimated Enrollment: 60
Study Start Date: May 2002
Estimated Study Completion Date: September 2004
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. 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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00276081


Locations
United States, New York
University of Rochester
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
National Institutes of Health (NIH)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Principal Investigator: Sireesha Y. Reddy, M.D. University of Rochester
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00276081     History of Changes
Other Study ID Numbers: RO3 HD042609 NIH/NICHD
First Submitted: January 11, 2006
First Posted: January 12, 2006
Last Update Posted: November 28, 2006
Last Verified: January 2006

Keywords provided by University of Rochester:
Hot flashes
postmenopausal
climacteric symptoms
hormone replacement therapy
gabapentin

Additional relevant MeSH terms:
Hot Flashes
Signs and Symptoms
Estrogens
Gabapentin
gamma-Aminobutyric Acid
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anticonvulsants
Antiparkinson Agents
Anti-Dyskinesia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Antimanic Agents
GABA Agents