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Study Evaluating Bazedoxifene/Conjugated Estrogen Combinations in Symptoms Associated With Menopause

Last updated on May 12, 2018

FOR MORE INFORMATION
Study Location
Phoenix, Arizona, 85105 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Vasomotor Symptoms Associated With Menopause
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
40-64 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Generally healthy, postmenopausal women, aged 40 to 64, with last natural menstrual
period completed at lease 6 months ago

- Intact uterus

- Seeking treatment for hot flushes and experiencing 7 moderate to severe hot flushes
per day or 50 per week

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

- History of active presence of thrombophlebitis, thrombosis, thromboembolic disorders

- History of active presence of stroke, TIA, heart attack or ischemic heart disease

- History of melanoma, breast or any gynecologic cancer at any time; history of any
other cancer within the past 5 years

NCT00234819
Pfizer
Completed
Study Evaluating Bazedoxifene/Conjugated Estrogen Combinations in Symptoms Associated With Menopause

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Study Evaluating Bazedoxifene/Conjugated Estrogen Combinations in Symptoms Associated With Menopause
A Double-Blind, Randomized, Placebo-Controlled, Efficacy and Safety Study of Bazedoxifene/Conjugated Estrogen Combinations for Treatment of Vasomotor Symptoms Associated With Menopause
The purpose of this study is to determine whether bazedoxifene/conjugated estrogens combinations are effective in the treatment of moderate to severe vasomotor symptoms associated with menopause.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Vasomotor Symptoms Associated With Menopause
Drug: Bazedoxifene/Conjugated Estrogen
Not Provided
Archer DF, Freeman EW, Komm BS, Ryan KA, Yu CR, Mirkin S, Pinkerton JV. Pooled Analysis of the Effects of Conjugated Estrogens/Bazedoxifene on Vasomotor Symptoms in the Selective Estrogens, Menopause, and Response to Therapy Trials. J Womens Health (Larchmt). 2016 Nov;25(11):1102-1111. Epub 2016 Sep 27.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
325
February 2007
Not Provided

Inclusion Criteria:

  • Generally healthy, postmenopausal women, aged 40 to 64, with last natural menstrual period completed at lease 6 months ago
  • Intact uterus
  • Seeking treatment for hot flushes and experiencing 7 moderate to severe hot flushes per day or 50 per week

Exclusion Criteria:

  • History of active presence of thrombophlebitis, thrombosis, thromboembolic disorders
  • History of active presence of stroke, TIA, heart attack or ischemic heart disease
  • History of melanoma, breast or any gynecologic cancer at any time; history of any other cancer within the past 5 years
Sexes Eligible for Study: Female
40 Years to 64 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00234819
3115A1-305
Not Provided
Not Provided
Not Provided
Not Provided
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
December 2007

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]



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