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

Completed · Phase 3 · Has a placebo group

Conditions studied: Hot Flashes

In brief

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

Key facts

Study ID

NCT00777023

Run by

Depomed

People needed

565

Starts

2008-10-01

Expected to finish

2009-10-01

Last updated by the study team

2012-02-22

Who can join

Age: 18 and older, up to 70. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Radiant Research — Birmingham, Alabama, United States
• Star W Research — Chandler, Arizona, United States
• Radiant Research — Scottsdale, Arizona, United States
• May Women's Health Clinic — Little Rock, Arkansas, United States
• Family Medical Center — Foothill Ranch, California, United States
• Genesis Center for Clinical Research — San Diego, California, United States
• Study site — San Diego, California, United States
• Medical Center for Clinical Research — San Diego, California, United States
• Milestone Medical Research, Inc. — Englewood, Colorado, United States
• Danbury Clinical Research, LLC — Danbury, Connecticut, United States
• Clinical Research Consulting, LLC — Milford, Connecticut, United States
• Meridien Research — Bradenton, Florida, United States
• Meridien Research — Brooksville, Florida, United States
• Clinical Research of West Florida, Inc. — Clearwater, Florida, United States
• Southeastern Integrated Medical, PL — Gainsville, Florida, United States
• Sunrise Medical Research — Lauderdale Lakes, Florida, United States
• University Clinical Research, Inc. — Pembroke Pines, Florida, United States
• Radiant Research - St. Petersburg — Pinellas Park, Florida, United States
• Atlanta Women's Research Institute, Inc. — Atlanta, Georgia, United States
• Atlanta West Women's Center — Douglasville, Georgia, United States
• Physician's Research Group — Indianapolis, Indiana, United States
• West Bank Women's Health — Marrero, Louisiana, United States
• ActivMed Practices and Research — Haverhill, Massachusetts, United States
• Women's Health Care Specialists, PC — Paw Paw, Michigan, United States
• Saginaw Valley Medical Research Group, LLC — Saginaw, Michigan, United States

Full record on ClinicalTrials.gov

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