Study of Gabapentin Extended Release (G-ER)in the Treatment of Vasomotor (Hot Flashes/Hot Flushes) Symptoms in Postmenopausal Women.
- Conditions
- Hot Flashes
- Interventions
- Registration Number
- NCT00777023
- Lead Sponsor
- Depomed
- 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
- Detailed Description
The primary study objective is to assess the efficacy of G-ER dosed in either of the following regimens:
G-ER 1200mg daily (single evening dose)
G-ER 1800mg daily (dosed asymmetrically; 600mg AM/1200mg PM)
compared to placebo in reducing the average daily frequency and severity score of moderate to severe hot flashes in postmenopausal women after 4 weeks and 12 weeks of treatment with a stable dose, compared with the baseline week.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 565
- Postmenopausal women aged 18 to 70 years experiencing ≥7 moderate to severe hot flashes per day (or ≥50 per week) accompanied by sweating during previous 30 days or longer.
- Had amenorrhea for ≥12 months, amenorrhea for 6 to 12 months with serum follicle-stimulating hormone (FSH) levels >40 mIU/mL, or was ≥6 weeks postsurgical bilateral oophorectomy with or without hysterectomy.
- Willing to discontinue the following: vaginal hormonal products; transdermal or oral estrogen or estrogen/progestin combination; intrauterine progestin; progestin implants; injectable estrogen; topical progesterone cream.
- Had to have daily average of ≥7 moderate to severe hot flashes and had to complete ≥4 days of diary entries during baseline week to be randomized.
- If treated with antidepressants, could not have had any changes in drug doses during past month.
Other Inclusions apply.
- Patient treated with a gonadotrophin releasing hormone agonist, anti-estrogens, or aromatase inhibitors within 2 months prior to study entry.
- Patient treated with estrogen pellets or progestin injectable drugs within 6 months prior to study entry.
- Patient experience only nighttime hot flashes or worked night shifts on a regular basis.
- Patient was concurrently treated with gabapentin for other indications. If patient was using gabapentin for treatment of hot flashes, she could be screened after a 7-day washout period provided hot flashes returned.
- Patient had previously experienced dose-limiting adverse effects that prevented titration of gabapentin to an effective dose.
- Patient had a hypersensitivity to gabapentin.
- Patient was in an immunocompromised state.
- Patient had a malignancy other than basal cell carcinoma within 2 years prior to study entry.
- Patient had gastric reduction surgery, severe chronic diarrhea, chronic constipation, uncontrolled irritable bowel syndrome, uncontrolled inflammatory bowel disease, or unexplained weight loss.
- Patient had clinically significant abnormal chemistry or hematology results, or calculated glomerular filtration rate <60 mL/min.
- Patient had history of substance abuse within year prior to study entry.
- Patient was concurrently taking morphine.
- Patient had history of chronic hepatitis B or C, hepatitis within 3 months prior to study entry, or history of human immunodeficiency virus.
Other Exclusions apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description G-ER 1200 mg Gabapentin Extended-Release (G-ER) 1200 mg Gabapentin extended-release (G-ER) 1200 mg G-ER 1800 mg Gabapentin Extended-Release (G-ER) 1800 mg Gabapentin extended-release (G-ER) 1800 mg Sugar Pill Placebo Placebo 1200 mg or 1800 mg
- Primary Outcome Measures
Name Time Method Change From Baseline in Average Daily Frequency of Moderate or Severe Hot Flashes After 4 Weeks of Treatment At baseline and 4 weeks of treatment Mean change from baseline in average daily number of moderate or severe hot flashes at stable dose week (SDW) 4 of treatment relative to placebo; last observation carried forward (LOCF) analysis
Change From Baseline in Average Daily Frequency of Moderate or Severe Hot Flashes After 12 Weeks of Treatment At baseline and 12 weeks of treatment Mean change from baseline in average daily number of moderate or severe hot flashes at stable dose week (SDW) 12 of treatment relative to placebo; last observation carried forward (LOCF) analysis
Change From Baseline in Average Daily Severity Score of Moderate or Severe Hot Flashes After 4 Weeks of Treatment At baseline and 4 weeks of treatment Mean change from baseline in average daily severity score of moderate or severe hot flashes at stable dose week (SDW) 4 of treatment relative to placebo; last observation carried forward (LOCF) analysis.
Severity of hot flashes is scored on a scale of 1 to 3 where 1=mild, 2=moderate, 3=severe.Change From Baseline in Average Daily Severity Score of Moderate or Severe Hot Flashes After 12 Weeks of Treatment At baseline and 12 weeks of treatment Mean change from baseline in average daily severity score of moderate or severe hot flashes at stable dose week (SDW) 12 of treatment relative to placebo; last observation carried forward (LOCF) analysis.
Severity of hot flashes is scored on a scale of 1 to 3 where 1=mild, 2=moderate, 3=severe.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (41)
Family Medical Center
🇺🇸Foothill Ranch, California, United States
Williamsburg Boro Park ObGyn, PC
🇺🇸New York, New York, United States
Genesis Center for Clinical Research
🇺🇸San Diego, California, United States
Medical Center for Clinical Research
🇺🇸San Diego, California, United States
Danbury Clinical Research, LLC
🇺🇸Danbury, Connecticut, United States
Atlanta Women's Research Institute, Inc.
🇺🇸Atlanta, Georgia, United States
Physician's Research Group
🇺🇸Indianapolis, Indiana, United States
Clinical Research Center of Nevada
🇺🇸Las Vegas, Nevada, United States
PMG/OB Gyn Health Center
🇺🇸Medford, Oregon, United States
InVisions Consultants, LLC
🇺🇸San Antonio, Texas, United States
Mid Dakota Clinic, PC
🇺🇸Bismarck, North Dakota, United States
Star W Research
🇺🇸Chandler, Arizona, United States
May Women's Health Clinic
🇺🇸Little Rock, Arkansas, United States
Southeastern Integrated Medical, PL
🇺🇸Gainsville, Florida, United States
Radiant Research, Inc.
🇺🇸Salt Lake City, Utah, United States
Milestone Medical Research, Inc.
🇺🇸Englewood, Colorado, United States
Meridien Research
🇺🇸Brooksville, Florida, United States
Sunrise Medical Research
🇺🇸Lauderdale Lakes, Florida, United States
Clinical Research of West Florida, Inc.
🇺🇸Clearwater, Florida, United States
University Clinical Research, Inc.
🇺🇸Pembroke Pines, Florida, United States
Radiant Research - St. Petersburg
🇺🇸Pinellas Park, Florida, United States
Atlanta West Women's Center
🇺🇸Douglasville, Georgia, United States
West Bank Women's Health
🇺🇸Marrero, Louisiana, United States
Saginaw Valley Medical Research Group, LLC
🇺🇸Saginaw, Michigan, United States
ActivMed Practices and Research
🇺🇸Haverhill, Massachusetts, United States
Aspen Medical Group
🇺🇸St. Paul, Minnesota, United States
Rapid Medical Research, Inc.
🇺🇸Cleaveland, Ohio, United States
Pinewest Ob-Gyn, Inc.
🇺🇸High Point, North Carolina, United States
Columbus Center for Women's Health Research
🇺🇸Columbus, Ohio, United States
Clinical Trials of America, Inc.
🇺🇸Eugene, Oregon, United States
Upstate Pharmaceutical Research
🇺🇸Greenville, South Carolina, United States
The Clinical Trial Center, LLC
🇺🇸Jenkintown, Pennsylvania, United States
Coastal Carolina Research Center, Inc.
🇺🇸Mt. Pleasant, South Carolina, United States
Alpha Clinical Research, LLC
🇺🇸Clarksville, Tennessee, United States
Renaissance Clinical Research and Hypertension Clinic
🇺🇸Dallas, Texas, United States
Clinical Research Investigative Services, LLC
🇺🇸Knoxville, Tennessee, United States
Advanced Clinical Research
🇺🇸West Jordan, Utah, United States
Mid-South OB-GYN, PLLC
🇺🇸Memphis, Tennessee, United States
Clinical Research Consulting, LLC
🇺🇸Milford, Connecticut, United States
Women's Health Care Specialists, PC
🇺🇸Paw Paw, Michigan, United States
Radiant Research
🇺🇸Scottsdale, Arizona, United States