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Study of Gabapentin Extended Release (G-ER) in the Treatment of Vasomotor (Hot Flashes/Hot Flushes) Symptoms in Postmenopausal Women

This study has been completed.
Information provided by:
Depomed Identifier:
First received: August 2, 2007
Last updated: June 6, 2011
Last verified: June 2011
Depomed's Gabapentin Extended Release is an investigational, extended release formulation of gabapentin that is being studied for the treatment of hot flashes in postmenopausal women.

Condition Intervention Phase
Hot Flashes Drug: Gabapentin Extended Release tablets Drug: Gabapentin Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Multicenter, Randomized, Double-blind, Placebo Controlled Study of the Pharmacokinetics (PK) and Pharmacodynamics (PD) of Gabapentin Extended Release (G-ER) Tablets in the Treatment of Vasomotor Symptoms in Postmenopausal Women

Resource links provided by NLM:

Further study details as provided by Depomed:

Primary Outcome Measures:
  • Frequency of moderate to severe hot flashes reported during the corresponding 24- hour blood samples collection period [ Time Frame: 24hrs ]
    PD end points are considered as primary outcomes of this study

Secondary Outcome Measures:
  • CGIC and PGIC evaluated prior to the start of 24- hour blood samples at week 6 and week 12 visits. [ Time Frame: 12 wks ]
    Efficacy variables

Estimated Enrollment: 108
Study Start Date: June 2007
Study Completion Date: February 2008
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Gabapentin ER
Active drug, Gabapentin extended release
Drug: Gabapentin Extended Release tablets
Drug: Gabapentin
Placebo Comparator: Sugar Pill
Comparator arm is Placebo
Drug: Gabapentin Extended Release tablets
Drug: Gabapentin

Detailed Description:
The primary objective of this clinical trial is to determine the optimal dose of Gabapentin ER in reducing the number and severity of hot flashes in postmenopausal women. Patients will be randomly assigned to Gabapentin ER or placebo, with a 1 in 4 chance of getting placebo. The total study investigational treatment duration after screening and baseline will be 13 weeks. The primary endpoint of the trial is to compare the number and severity of hot flashes during the investigational treatment compared to baseline. Sleep quality will also be evaluated.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Generally healthy, postmenopausal women who seek treatment for hot flashes.
  2. Patients using hormone replacement therapy (HRT) must be willing to discontinue treatment.
  3. Patients must be experiencing at least 7 moderate to severe hot flashes per day.
  4. Patient must be willing to commit to 3 (optionally 4) overnight stays at the study site that will include frequent blood sampling.

Other inclusions apply.

Exclusion Criteria:

  1. Patients with hypersensitivity to gabapentin.
  2. Patients with severe chronic diarrhea, chronic constipation, uncontrolled irritable bowel syndrome (IBS) or unexplained weight loss.
  3. Patients treated with estrogen pellets or injectable progestin drug therapy within 6 months.

Other exclusions apply.

  Contacts and Locations
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Please refer to this study by its identifier: NCT00511953

United States, California
Burbank, California, United States
United States, Florida
DeLand, Florida, United States
Port Orange, Florida, United States
United States, Kansas
Shawnee, Kansas, United States
United States, Maryland
Baltimore, Maryland, United States
United States, New Jersey
Hackensack, New Jersey, United States
United States, South Carolina
Greenville, South Carolina, United States
United States, Texas
San Antonio, Texas, United States
Sponsors and Collaborators
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Rekha Sathyanarayana, Depomed Identifier: NCT00511953     History of Changes
Other Study ID Numbers: 81-0056
Study First Received: August 2, 2007
Last Updated: June 6, 2011

Keywords provided by Depomed:
Hot flashes
Hot flushes
Postmenopausal symptoms

Additional relevant MeSH terms:
Hot Flashes
Signs and Symptoms
gamma-Aminobutyric Acid
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
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 processed this record on June 23, 2017