Menopause, Vasomotor System
Conditions
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.
Interventions
Sponsors
Wyeth is now a wholly owned subsidiary of Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The number and severity of hot flushes collected throughout the study after 12 weeks of therapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| The scores on the Greene Climacteric Scale (GCS), the Visual Analog Scale-Pain Intensity (VAS-PI), and the Satisfaction Survey (SS). | — |
| The number of awakenings due to VMS and the total mood disturbance score (Profile of Mood States [POMS]). | — |
Countries
United States
Outcome results
None listed