Clinical trial NCT00369434: Study of the Safety and Efficacy of Desvenlafaxine Succinate for Vasomotor Symptoms in Postmenopausal Women
Official title: A Double-Blind, Randomized, Placebo-Controlled, Efficacy and Safety Study of DVS SR for Treatment of Vasomotor Symptoms Associated With Menopause
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Menopause
Vasomotor System
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2006-08-29
Enrollment: 450
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and safety of 100 mg and 150 mg of DVS SR, an extended release form of desvenlafaxine succinate, in comparison to placebo for the treatment of Vasomotor Symptoms (VMS) associated with menopause in a population of postmenopausal women.

Detailed description: To assess the efficacy and safety of 100 mg and 150 mg of DVS SR in comparison to placebo for the treatment of moderate to severe VMS associated with menopause, as well as additional outcome indicators such as sleep disruptions, overall climacteric symptoms, mood changes, somatic symptoms, and overall satisfaction with DVS SR in postmenopausal women.

Eligibility 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

Other inclusions apply.

Exclusion Criteria:

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

Other exclusions apply.

Primary outcomes:
measure: The number and severity of hot flushes collected throughout the study after 12 weeks of therapy.
Secondary outcomes:
measure: The number of awakenings due to VMS and the total mood disturbance score (Profile of Mood States [POMS]).
measure: The scores on the Greene Climacteric Scale (GCS), the Visual Analog Scale-Pain Intensity (VAS-PI), and the Satisfaction Survey (SS).
Other outcomes:
Locations:
city: Montgomery
country: United States
state: Alabama
city: Peoria
country: United States
state: Arizona
city: Upland
country: United States
state: California
city: Colorado Springs
country: United States
state: Colorado
city: Brooksville
country: United States
state: Florida
city: Inverness
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: New Port Richey
country: United States
state: Florida
city: Ocala
country: United States
state: Florida
city: St. Petersburg
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Decatur
country: United States
state: Georgia
city: Savannah
country: United States
state: Georgia
city: Boise
country: United States
state: Idaho
city: Idaho Falls
country: United States
state: Idaho
city: Overland Park
country: United States
state: Kansas
city: Louisville
country: United States
state: Kentucky
city: Portland
country: United States
state: Maine
city: Rockville
country: United States
state: Maryland
city: Billings
country: United States
state: Montana
city: Las Vegas
country: United States
state: Nevada
city: Albuquerque
country: United States
state: New Mexico
city: Winston-Salem
country: United States
state: North Carolina
city: Bismark
country: United States
state: North Dakota
city: Fargo
country: United States
state: North Dakota
city: Cincinnati
country: United States
state: Ohio
city: Eugene
country: United States
state: Oregon
city: Erie
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Wexford
country: United States
state: Pennsylvania
city: Hilton Head Island
country: United States
state: South Carolina
city: Midvale
country: United States
state: Utah
city: Norfolk
country: United States
state: Virginia
city: Richmond
country: United States
state: Virginia
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References: