NCT00550303

Brief Summary

The primary purpose is to determine bioavailability of Bazedoxifene/conjugated estrogen formulations for future testing purposes.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Oct 2007

Shorter than P25 for phase_1 healthy

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
24 days 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

December 27, 2007

Status Verified

December 1, 2007

First QC Date

October 25, 2007

Last Update Submit

December 18, 2007

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Bioavailability

Secondary Outcomes (1)

  • Safety & tolerability

Interventions

bazedoxifene/conjugated estrogens combinationDRUG

Eligibility Criteria

Age45 Years - 70 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy, post menopausal women ages 45 to 70

You may not qualify if:

  • Male subjects

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

bazedoxifene

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

October 25, 2007

First Posted

October 29, 2007

Study Start

October 1, 2007

Study Completion

November 1, 2007

Last Updated

December 27, 2007

Record last verified: 2007-12