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

Completed · Phase 2

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

NCT00511953

Run by

Depomed

People needed

108

Starts

2007-06-01

Expected to finish

2008-02-01

Last updated by the study team

2011-06-08

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Generally healthy, postmenopausal women who seek treatment for hot flashes.
• Patients using hormone replacement therapy (HRT) must be willing to discontinue treatment.
• Patients must be experiencing at least 7 moderate to severe hot flashes per day.
• 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.

You may not qualify if…

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

Where it is running

• Study site — Burbank, California, United States
• Study site — DeLand, Florida, United States
• Study site — Port Orange, Florida, United States
• Study site — Shawnee, Kansas, United States
• Study site — Baltimore, Maryland, United States
• Study site — Hackensack, New Jersey, United States
• Study site — Greenville, South Carolina, United States
• Study site — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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