Study Evaluating Three Bazedoxifene/Conjugated Estrogens Combination Tablet Formulations Versus BZA Oral Solution

NCT00367536

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Postmenopause
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
35-70 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- Generally healthy, nonsmoking (or smoker of less than 10 cigarettes/day)

- Postmenopausal women aged 35 to 70 years

- At least 12 months of spontaneous amenorrhea, OR 6 months of spontaneous amenorrhea with follicle-stimulating hormone (FSH) levels at least 38 mIU/mL

- Women 55 years of older must have at least 12 months of amenorrhea

- Body mass index in the range of 18.0 to 35.0, with a minimum body weight of 50 kg

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


- A history or active presence of clinically important medical disease.


- History or alcoholism or drug abuse within 1 year before study start.


- Use of estrogen-, androgen-, or progestin-containing medication by a non-oral route of
administration within 6 months before study day 1 must be approved by Wyeth Research

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Advanced Information
Descriptive Information
Brief Title  ICMJE Study Evaluating Three Bazedoxifene/Conjugated Estrogens Combination Tablet Formulations Versus BZA Oral Solution
Official Title  ICMJE An Open-label, Single-dose, Randomized-to-sequence, 4-period Crossover Bioavailability Study of Bazedoxifene Contained in Bazedoxifene/Conjugated Estrogen Tablets Administered to Healthy Postmenopausal Women.
Brief Summary

This study involves the experimental drug bazedoxifene acetate/conjugated estrogens (also called BZA/CE). This drug is not approved by the Food and Drug Administration (FDA).

About 24 subjects will take part in this study. Each subject's participation in this study will last for about 10 weeks. During this study, each subject will receive 3 different types of BZA/CE tablets plus an oral solution containing only BZA. The purpose of this study is to learn how the tablet dosage forms dissolve and are absorbed by the body compared to the BZA oral solution. In addition, information will also be learned about the safety and tolerability of these dosage forms given to healthy postmenopausal women.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Not Provided
Condition  ICMJE Postmenopause
Intervention  ICMJE Drug: bazedoxifene/conjugated estrogens combination tablet
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   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: August 21, 2006)
24
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE August 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Generally healthy, nonsmoking (or smoker of less than 10 cigarettes/day)
  • Postmenopausal women aged 35 to 70 years
  • At least 12 months of spontaneous amenorrhea, OR 6 months of spontaneous amenorrhea with follicle-stimulating hormone (FSH) levels at least 38 mIU/mL
  • Women 55 years of older must have at least 12 months of amenorrhea
  • Body mass index in the range of 18.0 to 35.0, with a minimum body weight of 50 kg

Exclusion Criteria:

  • A history or active presence of clinically important medical disease.
  • History or alcoholism or drug abuse within 1 year before study start.
  • Use of estrogen-, androgen-, or progestin-containing medication by a non-oral route of administration within 6 months before study day 1 must be approved by Wyeth Research
Sex/Gender  ICMJE
Sexes Eligible for Study:Female
Ages  ICMJE 35 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00367536
Other Study ID Numbers  ICMJE 3115A1-115
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 MonitorWyeth is now a wholly owned subsidiary of Pfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date July 2009

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