NCT00550433

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

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

Timeline
Completed

Started Sep 2007

Shorter than P25 for phase_1

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, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 25, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 29, 2007

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
Last Updated

January 16, 2008

Status Verified

January 1, 2008

First QC Date

October 25, 2007

Last Update Submit

January 11, 2008

Conditions

Postmenopause

Outcome Measures

Primary Outcomes (1)

  • The plasma concentration data and pharmacokinetic (PK) parameters of BZA and CE.

Interventions

Bazedoxifene/Conjugated EstrogensDEVICE

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Medical Monitor

    Wyeth is now a wholly owned subsidiary of Pfizer

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

October 25, 2007

First Posted

October 29, 2007

Study Start

September 1, 2007

Study Completion

November 1, 2007

Last Updated

January 16, 2008

Record last verified: 2008-01