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Study Evaluating Potential Drug Interaction Of Bazedoxifene & Premarin In Healthy Postmenopausal Women

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00706225
First received: June 25, 2008
Last updated: September 21, 2010
Last verified: September 2010
History of Changes

June 25, 2008
September 21, 2010
June 2008
July 2008   (final data collection date for primary outcome measure)
To evaluate the potential pharmacokinetic (PK) interaction of multiple oral doses of bazedoxifene (BZA) and a single dose of conjugated estrogens (CE) when co administered to healthy postmenopausal women. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Pharmacokinetic (absorption, distribution, breakdown and elimination in the body) parameters [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00706225 on ClinicalTrials.gov Archive Site
To assess the safety of conjugated estrogens (CE) and bazedoxifene (BZA) when co administered to healthy postmenopausal women. [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
safety of CE & BZA [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
 
 
 
Study Evaluating Potential Drug Interaction Of Bazedoxifene & Premarin In Healthy Postmenopausal Women
An Open-Label, Single/Multiple Dose, Non-Randomized, 3-Period, Crossover Study To Determine The Potential Drug Interaction Of Bazedoxifene On Conjugated Estrogens (CE) In Healthy Postmenopausal Women

Bazedoxifene (BZA) 20 mg tablet is an investigational medication (not approved by FDA) which is being studied for possible prevention and treatment of postmenopausal osteoporosis.

PREMARIN® (conjugated estrogens [CE]) is approved by FDA to treat moderate to severe symptoms of menopause (i.e., hot flashes, and/or vulvar and vaginal atrophy) and for the prevention of postmenopausal osteoporosis.

The purpose of this study is to evaluate the pharmacokinetics (absorption, distribution, breakdown and elimination in the body) of a single dose of PREMARIN® when administered together with multiple doses of bazedoxifene (BZA) to healthy postmenopausal women.

Information will also be obtained regarding the safety and tolerability of the study medications when given together to healthy postmenopausal women.
 
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention
Postmenopause
Drug: Bazedoxifene and conjugated estrogens
Bazedoxifene 20 mg tablet once daily for 7 days. Conjugated Estrogens 0.625 mg tablet, single doses one week apart.
Experimental: 1
Bazedoxifene and Conjugated Estrogens (BZA & CE)
Intervention: Drug: Bazedoxifene and conjugated estrogens
 

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

Inclusion Criteria:

  • Healthy, postmenopausal woman, (either naturally or surgically and have blood hormone levels consistent with a postmenopausal state for specified subjects) between the ages of 35 and 70 years, inclusive
  • Have not participated in a clinical drug study for at least 30 days prior to study medication administration,
  • Must not have a history of drug or alcohol abuse within 1 year and do not 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)
  • Must either be a non-smoker or smoke less than 10 cigarettes per day, and must be able to abstain from smoking during clinic confinements,
  • Must not donate any other plasma or blood during the total study.
  • All test results and study criteria for the study are met.

Exclusion Criteria:

  • Only healthy postmenopausal women are eligible.
  • Health assessed by clinical chemistry laboratory results and physical exam.
Female
35 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00706225
3115A1-1134
No
Director, Clinical Trial Disclosure Group, Pfizer, Inc
Wyeth is now a wholly owned subsidiary of Pfizer
 
Study Director: Pfizer CT.gov Call Center Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
September 2010

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