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Study Evaluating Bazedoxifene/Conjugated Estrogens Combinations In Healthy Postmenopausal Women

This study has been completed.
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer Identifier:
First received: April 23, 2007
Last updated: December 19, 2007
Last verified: December 2007
Bazedoxifene/Conjugated Estrogens (BZA/CE) is an investigational drug that is being developed for treatment of menopause. The purpose of this trial is to compare a new manufacturing process for making BZA/CE to the current process by assessing the way it is absorbed into the blood.

Condition Intervention Phase
Drug: Bazedoxifene/Conjugated Estrogens 20 mg/0.625 mg tablet
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label, Single-Dose, Randomized, 3-Period, Crossover, Bioequivalence Study Between Bazedoxifene/Conjugated Estrogens (Premarin Current Process) And Bazedoxifene/Conjugated Estrogens (Premarin New Process) In Healthy Postmenopausal Women

Resource links provided by NLM:

Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:
  • PK results

Study Start Date: March 2007
Study Completion Date: May 2007

Ages Eligible for Study:   35 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Postmenopausal women aged 35 to 70 years
  • 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
  • Healthy as determined by the investigator on the basis of medical history, physical examination, breast and gynecologic examination, clinical laboratory test results, vital signs, and 12-lead electrocardiogram (ECG).

Exclusion Criteria:

  • Any clinically important active condition of gynecologic, cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
  • History or current evidence of thrombophlebitis, thromboembolic disorders, or any coagulopathies.
  • History of any clinically important drug allergy to conjugated estrogens (CE) or selective estrogen receptor modulators (SERMs).
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Please refer to this study by its identifier: NCT00464789

Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
  More Information Identifier: NCT00464789     History of Changes
Other Study ID Numbers: 3115A1-1120
Study First Received: April 23, 2007
Last Updated: December 19, 2007

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Additional relevant MeSH terms:
Estrogens, Conjugated (USP)
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Bone Density Conservation Agents
Hormones processed this record on May 25, 2017