CClinicalTrials.gg
CompletedNCT00550433Updated Jan 16, 2008

Study Evaluating Bazedoxifene/CE in Postmenopausal Women

A Phase 1 interventional study of Bazedoxifene/Conjugated Estrogens in Postmenopause, sponsored by Wyeth is now a wholly owned subsidiary of Pfizer. Completed. Open to female participants aged 35 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2008-01-16.

Sponsored by Wyeth is now a wholly owned subsidiary of Pfizer · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Allocation
Randomized
Ages
35 Years to 70 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Postmenopause
03

In context

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer is the lead sponsor of 472 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
35 Years to 70 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)

Interventions

  • DeviceBazedoxifene/Conjugated Estrogens
06

What researchers measure

Primary outcomes

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

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 16, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00550433
Lead sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
First posted
Oct 29, 2007
Start date
Sep 2007
Completion
Nov 2007
Last update
Jan 16, 2008

Study contacts

Medical Monitor
study director · Wyeth is now a wholly owned subsidiary of Pfizer

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2008. You cannot join it, but the record below documents what was studied.

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