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

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. Identifier: NCT00511953
Recruitment Status : Completed
First Posted : August 6, 2007
Last Update Posted : June 8, 2011
Information provided by:

Brief Summary:
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 or disease Intervention/treatment Phase
Hot Flashes Drug: Gabapentin Extended Release tablets Drug: Gabapentin Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (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
Study Start Date : June 2007
Actual Primary Completion Date : December 2007
Actual Study Completion Date : February 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 :
  1. 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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.

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 identifier (NCT number): 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

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
First Posted: August 6, 2007    Key Record Dates
Last Update Posted: June 8, 2011
Last Verified: June 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