Hot Flashes Clinical Trial
Official title:
A Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Safety and Efficacy of Gabapentin Extended Release (G-ER) Tablets in the Treatment of Vasomotor Symptoms in Postmenopausal Women
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.
The primary study objective is to assess the efficacy of G-ER dosed in either of the
following regimens:
- G-ER 1200 mg daily (single evening dose)
- G-ER 1800 mg daily (dosed asymmetrically; 600 mg in AM/1200 mg in PM) compared to
placebo in reducing the average daily frequency and severity score of moderate to
severe hot flashes in postmenopausal women after 4 weeks and 12 weeks of treatment with
a stable dose, compared with the baseline week.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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