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

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

Outcome

Met primary endpoint

paper Desvenlafaxine 100 mg/d achieved a significantly greater reduction compared with placebo in average daily number of hot flushes at weeks 4 (P=.013) and 12 (P=.005) PMID 18165395 ↗

paper Average daily severity of hot flushes was significantly lower in the desvenlafaxine 100-mg group compared with placebo at week 12 (P=.020). PMID 18165395 ↗

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.