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Study Evaluating Bazedoxifene/CE in Postmenopausal Women

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NCT00550433

Last updated on May 11, 2018
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Study Location
Contact
1-800-718-1021
[email protected]
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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.
Show details

- Postmenopausal women aged 35 to 70 years.

- Spontaneous or surgical amenorrhea for at least 6 months.

- Body mass index (BMI) in the range of 18.0 to 35.0 kg/m2 and body weight greater than
or equal to 50 kg.

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

- Hypertension or elevated supine blood pressure (>139 mm Hg systolic or >89 mm Hg
diastolic).

- History of any clinically important drug allergy.

- Use of any prescription or investigational drug within 30 days before test article
administration.

NCT00550433
Pfizer
Completed
Study Evaluating Bazedoxifene/CE in Postmenopausal Women

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Study Evaluating Bazedoxifene/CE in Postmenopausal Women
An Open-Label, Single-Dose, Randomized, 4-Period, Crossover, Bioequivalence Study of Clinical and Commercial Formulations of Bazedoxifene/Conjugated Estrogens in Healthy Postmenopausal Women
The purpose of this clinical trial is to study the blood levels of a drug (conjugated estrogens) in the body from one dosage form compared to another. The four formulations of the study drug that eligible participants will receive will contain the same amounts of the same medications. In addition, information will also be obtained regarding the safety and tolerability of the formulations given to healthy postmenopausal women.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Postmenopause
Device: Bazedoxifene/Conjugated Estrogens
Not Provided
Not Provided


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

Inclusion Criteria:

  • Postmenopausal women aged 35 to 70 years.
  • Spontaneous or surgical amenorrhea for at least 6 months.
  • Body mass index (BMI) in the range of 18.0 to 35.0 kg/m2 and body weight greater than or equal to 50 kg.

Exclusion Criteria:

  • Hypertension or elevated supine blood pressure (>139 mm Hg systolic or >89 mm Hg diastolic).
  • History of any clinically important drug allergy.
  • Use of any prescription or investigational drug within 30 days before test article administration.
Sexes Eligible for Study: Female
35 Years to 70 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00550433
3115A1-1117
No
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
January 2008

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.

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1-800-718-1021

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[email protected]



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