Study Evaluating the Safety & Efficacy of DVS-223 SR for Relief of Vasomotor Symptoms Associated With Menopause

Phase 3 Completed 540 enrolled Wyeth is now a wholly owned subsidiary of Pfizer

RandomizedSingle-groupDouble-blindTreatment

Summary

The purpose of this study is to assess the efficacy and safety of 4 doses of desvenlafaxine-233 sustained release (DVS-233 SR) as compared to placebo for the treatment of moderate to severe vasomotor symptoms associated with menopause, as well as its influence on sleep parameters and other health outcomes indicators.

Timeline

Start: 2003-12
Primary completion: —
Completion: 2004-04

Publications

Speroff L, Gass M, Constantine G, Olivier S; Study 315 Investigators. Efficacy and tolerability of desvenlafaxine succinate treatment for menopausal vasomotor symptoms: a randomized controlled trial. Obstet Gynecol. 2008 Jan;111(1):77-87. doi: 10.1097/01.AOG.0000297371.89129.b3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Desvenlafaxine	Other / unclassified	50 mg	—
Subject	Desvenlafaxine	Other / unclassified	100 mg	—
Subject	Desvenlafaxine	Other / unclassified	150 mg	—
Subject	Desvenlafaxine	Other / unclassified	200 mg	—

Indications

No indication recorded.