Study Evaluating Potential Drug Interaction Of Bazedoxifene & Premarin 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.

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Key information

Conditions

Postmenopause

Age range

35 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Daytona Beach, Florida, 32117, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bazedoxifene and conjugated estrogens

Drug

Bazedoxifene 20 mg tablet once daily for 7 days. Conjugated Estrogens 0.625 mg tablet, single doses one week apart.

Primary outcomes

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

Secondary outcomes

To assess the safety of conjugated estrogens (CE) and bazedoxifene (BZA) when co administered to healthy postmenopausal women.

Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start: 2008
Primary completion: 2008
Study completion: 2008
First posted: Jun 27, 2008
Registry last updated: Sep 23, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed