NCT00745173

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Sep 2008

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

September 2, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 3, 2008

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
Last Updated

February 12, 2009

Status Verified

February 1, 2009

Enrollment Period

1 month

First QC Date

September 2, 2008

Last Update Submit

February 11, 2009

Conditions

Postmenopause

Outcome Measures

Primary Outcomes (1)

  • Pharmacokinetic (absorption, distribution, breakdown and elimination in the body) parameters

    3 months

Secondary Outcomes (1)

  • To continue assessment of the safety profile as well as the tolerability the two drugs administered in combination in this population.

    3 months

Study Arms (1)

1

OTHER
Drug: Premarin

Interventions

PremarinDRUG
1

Eligibility Criteria

Age35 Years - 70 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr. David Carter

Austin, Texas, 78752, United States

Location

MeSH Terms

Interventions

Estrogens, Conjugated (USP)

Intervention Hierarchy (Ancestors)

Estradiol CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Medical Monitor

    Wyeth is now a wholly owned subsidiary of Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 2, 2008

First Posted

September 3, 2008

Study Start

September 1, 2008

Primary Completion

October 1, 2008

Study Completion

October 1, 2008

Last Updated

February 12, 2009

Record last verified: 2009-02

Locations

US(1)