drugset

drugset / Trial / NCT00366093

Study of Eszopiclone Compared to Placebo in the Treatment of Insomnia Secondary to Perimenopause/Menopause

NCT00366093 ↗

Phase 3 Completed 410 enrolled Sumitomo Pharma America, Inc.

RandomizedParallel-groupTriple-blindTreatment

Summary

To demonstrate improved subjective sleep in women with insomnia secondary to perimenopause or menopause following treatment with 3 mg of eszopiclone.

Timeline

Start: 2004-02
Primary completion: 2005-01
Completion: 2005-01

Publications

Soares CN, Joffe H, Rubens R, Caron J, Roth T, Cohen L. Eszopiclone in patients with insomnia during perimenopause and early postmenopause: a randomized controlled trial. Obstet Gynecol. 2006 Dec;108(6):1402-10. doi: 10.1097/01.AOG.0000245449.97365.97.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Eszopiclone	Small molecule	3 mg	—

Indications