Study Evaluating The Safety And Efficacy Of Desvenlafaxine Succinate For Vasomotor Symptoms In Menopausal Women

Pfizer

Status and phase: Completed; Phase 3

Conditions: Vasomotor Symptoms

Treatments: Drug: Placebo; Drug: desvenlafaxine succinate (DVS) SR

Study type: Interventional

Funder types: Industry

Identifiers

NCT00683800

B2061011

3151A2-3353

Details and patient eligibility

About

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

Enrollment: 2,186 patients

Sex: Female

Ages: 45+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Generally healthy, postmenopausal women who seek treatment for hot flushes
• Body Mass Index (BMI) less than or equal to 34 kg/m^2

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

2,186 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

desvenlafaxine succinate (DVS) SR

Treatment:

Drug: desvenlafaxine succinate (DVS) SR

2

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo