Study of Gabapentin Extended Release (G-ER) in the Treatment of Vasomotor (Hot Flashes/Hot Flushes) Symptoms in Postmenopausal Women
Condition: Hot Flashes
MeSH terms: Hot Flashes
Intervention: Gabapentin Extended-Release (G-ER) 1200 mg; Gabapentin Extended-Release (G-ER) 1800 mg; Placebo
Intervention description: G-ER 1200 mg daily dosage given as two 600-mg tablets.; G-ER 1800 mg daily dosage given as one 600-mg tablet in the morning and two 600-mg tablets in the evening.; Matching placebo dosages of 1200 mg daily (two 600-mg tablets) and 1800 mg daily (one 600-mg tablet in the morning and two 600-mg tablets in the evening).
Intervention MeSH terms: Gabapentin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 541.0
Sex: Female
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Hot flashes; Hot flushes; Postmenopausal symptoms; Vasomotor symptoms

Summary:

      Depomed's Gabapentin Extended Release (G-ER) is an investigational, extended release
      formulation of gabapentin that is being studied for the treatment of hot flashes in
      postmenopausal women.
    

Eligibility criteria:

        Inclusion Criteria:

          1. 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.

          2. 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.

          3. 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.

          4. 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.

          5. If treated with antidepressants, could not have had any changes in drug doses during
             past month.

        Other Inclusions apply.

        Exclusion Criteria:

          1. Patient treated with a gonadotrophin releasing hormone agonist, anti-estrogens, or
             aromatase inhibitors within 2 months prior to study entry.

          2. Patient treated with estrogen pellets or progestin injectable drugs within 6 months
             prior to study entry.

          3. Patient experience only nighttime hot flashes or worked night shifts on a regular
             basis.

          4. 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.

          5. Patient had previously experienced dose-limiting adverse events that prevented
             titration of gabapentin to an effective dose.

          6. Patient had a hypersensitivity to gabapentin.

          7. Patient was in an immunocompromised state.

          8. Patient had a malignancy other than basal cell carcinoma within 2 years prior to study
             entry.

          9. Patient had gastric reduction surgery, severe chronic diarrhea, chronic constipation,
             uncontrolled irritable bowel syndrome, uncontrolled inflammatory bowel disease, or
             unexplained weight loss.

         10. Patient had clinically significant abnormal chemistry or hematology results, or
             calculated glomerular filtration rate <60 mL/min.

         11. Patient had history of substance abuse within year prior to study entry.

         12. Patient was concurrently taking morphine.

         13. 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.