Breeze3:Study of Gabapentin Extended Release in the Treatment of Vasomotor Symptoms(Hot Flashes)in Postmenopausal Women

• Status: Completed
• Trial end date: 2011-09-01
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Depomed
• Treatments: Gabapentin; gamma-Aminobutyric Acid

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.