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Trial record 1 of 1 for:    NCT00234819
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Study Evaluating Bazedoxifene/Conjugated Estrogen Combinations in Symptoms Associated With Menopause

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ClinicalTrials.gov Identifier: NCT00234819
Recruitment Status : Completed
First Posted : October 7, 2005
Last Update Posted : December 28, 2007
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Tracking Information
First Submitted Date  ICMJE October 5, 2005
First Posted Date  ICMJE October 7, 2005
Last Update Posted Date December 28, 2007
Study Start Date  ICMJE October 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: October 5, 2005)
Number and severity of moderate and severe hot flashes at week 4 and at week 12, as reported daily on subject diary cards.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00234819 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 5, 2005)
Breast pain throughout the 12 week study, as reported daily on subject diary cards. Sleep scales and sleep quantity at week 4 and week 12, as indicated on a subject-completed questionnaire.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Evaluating Bazedoxifene/Conjugated Estrogen Combinations in Symptoms Associated With Menopause
Official Title  ICMJE A Double-Blind, Randomized, Placebo-Controlled, Efficacy and Safety Study of Bazedoxifene/Conjugated Estrogen Combinations for Treatment of Vasomotor Symptoms Associated With Menopause
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Vasomotor Symptoms Associated With Menopause
Intervention  ICMJE Drug: Bazedoxifene/Conjugated Estrogen
Study Arms  ICMJE Not Provided
Publications * 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.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: October 5, 2005)
325
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 40 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00234819
Other Study ID Numbers  ICMJE 3115A1-305
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP