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Keep this study
Lead
Depomed
The primary objective of this clinical trial is to determine the optimal dose of Gabapentin ER in reducing the number and severity of hot flashes in postmenopausal women. Patients will be randomly assigned to Gabapentin ER or placebo, with a 1 in 4 chance of getting placebo. The total study investigational treatment duration after screening and baseline will be 13 weeks. The primary endpoint of the trial is to compare the number and severity of hot flashes during the investigational treatment compared to baseline. Sleep quality will also be evaluated.
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
1. Generally healthy, postmenopausal women who seek treatment for hot flashes.
2. Patients using hormone replacement therapy (HRT) must be willing to discontinue treatment.
3. Patients must be experiencing at least 7 moderate to severe hot flashes per day.
4. 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 be if
1. Patients with hypersensitivity to gabapentin.
2. Patients with severe chronic diarrhea, chronic constipation, uncontrolled irritable bowel syndrome (IBS) or unexplained weight loss.
3. Patients treated with estrogen pellets or injectable progestin drug therapy within 6 months.
Other exclusions apply.
Clareo Health | Study of Gabapentin Extended Release (G-ER) in the Treatment of Vasomotor (Hot Flashes/Hot Flushes) Symptoms in Postmenopausal Women
