You are here

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

Last updated on May 11, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Birmingham, Alabama, 35235 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Vasomotor Symptoms
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
45+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Hypersensitivity to Venlafaxine

- Myocardial infarction an/or unstable angina within 6 months of screening

- History of seizure disorder

NCT00683800
Pfizer
Completed
Study Evaluating The Safety And Efficacy Of Desvenlafaxine Succinate For Vasomotor Symptoms In Menopausal Women

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your zip code, city, or country to find studies near you.

Similar Trials

Severe Vasomotor Symptom Associated With Menopause
NCT02792504
Females
20+
Years
Multiple Sites
Menopause, Vasomotor System
NCT00369434
Females
0+
Years
Multiple Sites
Vasomotor Symptoms Associated With Menopause
NCT00234819
Females
40+
Years
Multiple Sites
Study Evaluating The Safety And Efficacy Of Desvenlafaxine Succinate For Vasomotor Symptoms In Menopausal Women
A Double-Blind, Randomized, Placebo-Controlled Study Assessing The Safety And Efficacy Of DVS SR For The Treatment Of Vasomotor Symptoms Associated With Menopause
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Vasomotor Symptoms
  • Drug: desvenlafaxine succinate (DVS) SR
    Titration with 50 mg tablets once daily for 7 days, then 100mg tablets once daily from day 8 to day 365, then taper with 50 mg tablets once daily for 7 days, followed by 25 mg tablets once daily for 7 days.
  • Drug: Placebo
    Titration with 50 mg placebo tablets once daily for 7 days, then 100mg placebo tablets once daily from day 8 to day 365, then taper with 50 mg placebo tablets once daily for 7 days, followed by 25 mg placebo tablets once daily for 7 days.
  • Experimental: 1
    desvenlafaxine succinate (DVS) SR
    Intervention: Drug: desvenlafaxine succinate (DVS) SR
  • Placebo Comparator: 2
    Placebo
    Intervention: Drug: Placebo


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2186
May 2010
May 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
45 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Canada,   United States
 
 
NCT00683800
3151A2-3353
B2061011
Yes
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
July 2011

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



Call Now