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NCT00706225

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

Completed Phase 1 Last updated 21 September 2010
What this trial tests

Phase 1 trial testing Bazedoxifene and conjugated estrogens in Postmenopause in 30 participants. Completed in 1 July 2008.

Timeline
1 June 2008
Primary endpoint
1 July 2008
1 July 2008

Quick facts

Lead sponsorWyeth is now a wholly owned subsidiary of Pfizer
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designcrossover
Maskingnone
Primary purposeprevention
Enrollment30
Start date1 June 2008
Primary completion1 July 2008
Estimated completion1 July 2008
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer — full company profile →

Who can join

Adults 35 to 70, female only, with Postmenopause. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other recruiting trials for Postmenopause

Currently open trials in the same condition.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00706225.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing