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Study Evaluating Premarin and Bazedoxifene Potential Interaction

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
Dr. David Carter
Austin, Texas, 78752 United States
Contact
1-800-718-1021
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.
Show details

- For inclusion into the study, women must be healthy and postmenopausal (either
naturally or surgically) between the ages of 35 and 70, inclusive.

- Blood hormone levels must be consistent with a postmenopausal state (for specified
subjects).

- They can either be a non-smoker or smoke less than 10 cigarettes per day, and be able
to abstain from smoking during clinic confinements

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

- A subject will be excluded from participation if they :

- Have participated in a clinical drug study within 30 days prior to study medication
administration;

- Have a history of drug or alcohol abuse within 1 year or consume more than 2 standard
units per day of alcohol (a standard unit equals 12 ounces of beer, 1 ½ ounces of
80-proof alcohol or 6 ounces of wine);

- Donate any other plasma or blood during the total study.

NCT00745173
Pfizer
Completed
Study Evaluating Premarin and Bazedoxifene Potential Interaction

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Study Evaluating Premarin and Bazedoxifene Potential Interaction
An Open-Label, Single/Multiple Dose Non-Randomized, 3-Period, Crossover Study To Determine The Potential Drug Interaction Of Conjugated Estrogens (CE) On Bazedoxifene In Healthy Postmenopausal Women.

The purpose of this study is to evaluate the pharmacokinetics (absorption, distribution, breakdown and elimination in the body) of a single dose of bazedoxifene (BZA) 20 mg tablet when administered together with multiple doses of Premarin (conjugated estrogens or CE) to healthy postmenopausal women.

Information will also be obtained regarding the safety and tolerability of this combination in healthy, postmenopausal women.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Postmenopause
Drug: Premarin
1
Intervention: Drug: Premarin
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
October 2008
October 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • For inclusion into the study, women must be healthy and postmenopausal (either naturally or surgically) between the ages of 35 and 70, inclusive.
  • Blood hormone levels must be consistent with a postmenopausal state (for specified subjects).
  • They can either be a non-smoker or smoke less than 10 cigarettes per day, and be able to abstain from smoking during clinic confinements

Exclusion Criteria:

  • A subject will be excluded from participation if they :
  • Have participated in a clinical drug study within 30 days prior to study medication administration;
  • Have a history of drug or alcohol abuse within 1 year or consume more than 2 standard units per day of alcohol (a standard unit equals 12 ounces of beer, 1 ½ ounces of 80-proof alcohol or 6 ounces of wine);
  • Donate any other plasma or blood during the total study.
Sexes Eligible for Study: Female
35 Years to 70 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00745173
3115A1-1135
No
Not Provided
Not Provided
Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
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
February 2009

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

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Contact

[email protected]



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