Breeze3:Study of Gabapentin Extended Release in the Treatment of Vasomotor Symptoms(Hot Flashes)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/Hot Flushes in postmenopausal women

Key facts

Study ID

NCT01080300

Run by

Depomed

People needed

600

Starts

2010-08-01

Expected to finish

2011-09-01

Last updated by the study team

2020-05-01

Who can join

Age: 18 and older, up to 70. 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 moderate to severe hot flashes
• Patients must be able to sign the informed consent
• Patients must be able to enter simple commands and complete questionnaires on the frequency and severity of their hot flashes using an electronic diary
• 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.
• Patients currently treated with Gabapentin or Pregabalin for any indication, including vasomotor symptoms
• Other exclusions apply.

Where it is running

• Study site — Mobile, Alabama, United States
• Study site — Phoenix, Arizona, United States
• Study site — Scottsdale, Arizona, United States
• Study site — Tucson, Arizona, United States
• Study site — Little Rock, Arkansas, United States
• Study site — Berkeley, California, United States
• Study site — Roseville, California, United States
• Study site — San Diego, California, United States
• Study site — Denver, Colorado, United States
• Study site — Danbury, Connecticut, United States
• Study site — Milford, Connecticut, United States
• Study site — Brooksville, Florida, United States
• Study site — Clearwater, Florida, United States
• Study site — DeLand, Florida, United States
• Study site — Gainesville, Florida, United States
• Study site — Naples, Florida, United States
• Study site — New Port Richey, Florida, United States
• Study site — North Miami, Florida, United States
• Study site — Orlando, Florida, United States
• Study site — Decatur, Georgia, United States
• Study site — Idaho Falls, Idaho, United States
• Study site — Indianapolis, Indiana, United States
• Study site — South Bend, Indiana, United States
• Study site — Overland Park, Kansas, United States
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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