Conditions: Hot Flashes
Keywords: Hot flashes Hot flushes Postmenopausal symptoms Vasomotor symptoms
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 541
Healthy volunteers: no

Brief 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.

Detailed description:
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.

Arms:
arm 1: Gabapentin extended-release (G-ER) 1200 mg arm 2: Gabapentin extended-release (G-ER) 1800 mg arm 3: Placebo 1200 mg or 1800 mg

Interventions: intervention 1: Gabapentin Extended-Release (G-ER) 1200 mg intervention 2: Gabapentin Extended-Release (G-ER) 1800 mg intervention 3: Placebo
Intervention descriptions: intervention 1: G-ER 1200 mg daily dosage given as two 600-mg tablets. intervention 2: G-ER 1800 mg daily dosage given as one 600-mg tablet in the morning and two 600-mg tablets in the evening. intervention 3: 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).

Protocol document: