Study Evaluating DVS-233 SR to Treat Vasomotor Systems Associated With Menopause

A Double-Blind, Randomized, Placebo-Controlled Efficacy and Safety Study of DVS-233 SR for Treatment of Vasomotor Symptoms Associated With Menopause

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00256685

Enrollment

568

Registered

2005-11-21

Start date

2004-09-30

Completion date

2005-07-31

Last updated

2006-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hot Flashes, Menopause, Sleep Disorders

Keywords

Menopause

Brief summary

The purpose of this study is to assess the safety and efficacy of desvenlafaxine succinate (DVS) for treatment of moderate to severe vasomotor symptoms (VMS) that are associated with menopause, and also to assess the effects of DVS on sleep parameters and health outcomes indicators.

Interventions

DRUGDVS-233 SR

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

FEMALE

Age

0 Years to No maximum

Healthy volunteers

Inclusion criteria

* Generally healthy, postmenopausal women who seek treatment for hot flushes * Minimum of 7 moderate to severe hot flushes per day or 50 per week recorded for 7 consecutive days during screening * Body Mass Index (BMI) less than or equal to 40 kg/m2 Other inclusions apply.

Exclusion criteria

* Hypersensitivity to Venlafaxine * History of seizure disorder * History of myocardial infarction or unstable angina within 6 months Other exclusions apply.

Design outcomes

Primary

Measure	Time frame
Reduction in average daily number of moderate & severe hot flushes and average daily severity score at weeks 4 & 12	—

Secondary

Measure	Time frame
Sleep, mood	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026