Study of Gabapentin Extended Release (G-ER)in the Treatment of Vasomotor (Hot Flashes/Hot Flushes) Symptoms in Postmenopausal Women.

Summary

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

Timeline

Start

2008-10

Primary completion

2009-07

Completion

2009-10

Outcome

Mixed primary results

registry analysis (superiority or other test); G-ER 1200 mg vs Sugar Pill; p = 0.0024; Mean Difference (Net) -1.61 (97.5% CI -2.80 to -0.42); NCT00777023 ↗

registry analysis (superiority or other test); G-ER 1200 mg vs Sugar Pill; p = 0.0608; Mean Difference (Net) -0.15 (97.5% CI -0.32 to -0.03); NCT00777023 ↗

registry analysis (superiority or other test); G-ER 1800 mg vs Sugar Pill; p = 0.0003; Mean Difference (Net) -0.28 (97.5% CI -0.45 to -0.11); NCT00777023 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Gabapentin	Unknown	1200 mg	—
Subject	Gabapentin	Unknown	1800 mg	—

Indications

No indication recorded.