Study Evaluating the Safety and Efficacy of Desvenlafaxine Succinate for Vasomotor Symptoms in Menopausal Women - Full Text View

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00683800

Purpose

The purpose of the study is to evaluate the efficacy and safety of Desvenlafaxine Succinate (DVS) SR, in comparison to placebo for the treatment of Vasomotor Symptoms (VMS) in menopausal women.

Condition	Intervention	Phase
Vasomotor Symptoms	Drug: desvenlafaxine succinate (DVS) SR Drug: Placebo	Phase III

MedlinePlus related topics: Menopause

Drug Information available for: Succinic acid Desvenlafaxine Succinate Desvenlafaxine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Single Group Assignment, Safety/Efficacy Study
Official Title:	A Double-Blind, Randomized, Placebo-Controlled Study Assessing the Safety and Efficacy of DVS SR for the Treatment of Vasomotor Symptoms Associated With Menopause

Further study details as provided by Wyeth:

Primary Outcome Measures:

To obtain additional safety and efficacy information about DVS SR for treating hot flushes associated with menopause. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To assess whether the treatment with DVS SR affects the bothersomeness of hot flushes to assess the number of hot flushes, and of other safety endpoints. [ Time Frame: 3 months - 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	2000
Study Start Date:	May 2008
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental desvenlafaxine succinate (DVS) SR	Drug: desvenlafaxine succinate (DVS) SR
2: Placebo Comparator Placebo	Drug: Placebo

Eligibility

Ages Eligible for Study:	45 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Generally healthy, postmenopausal women who seek treatment for hot flushes
Body Mass Index (BMI) less than or equal to 40 kg/m2

Exclusion Criteria:

Hypersensitivity to Venlafaxine
Myocardial infarction an/or unstable angina within 6 months of screening
History of seizure disorder

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00683800

Show 129 Study Locations

Sponsors and Collaborators

Wyeth

More Information

Responsible Party:	Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) )
Study ID Numbers:	3151A2-3353
Study First Received:	May 21, 2008
Last Updated:	January 13, 2009
ClinicalTrials.gov Identifier:	NCT00683800
Health Authority:	United States: Food and Drug Administration

Keywords provided by Wyeth:

Menopause
Hot Flush
Hot Flash
DVS SR

Study placed in the following topic categories:

O-desmethylvenlafaxine
Hot Flashes
Flushing
Menopause

Additional relevant MeSH terms:

Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Physiological Effects of Drugs

Psychotropic Drugs
Central Nervous System Agents
Antidepressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009