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Completed

NCT Number: NCT00675688

Study Evaluating Safety and Efficacy of Bazedoxifene/Conjugated Estrogens Combinations in Postmenopausal Women

The purpose of this study is to determine whether bazedoxifene/conjugated estrogens combinations are effective for the prevention of endometrial hyperplasia and for the prevention of osteoporosis in postmenopausal women.

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Key information

Conditions

Endometrial Hyperplasia Bone Diseases Bone Diseases, Metabolic Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoporosis Urogenital Diseases Uterine Diseases

Age range

40 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Generally healthy, postmenopausal women aged 40 - 75 years inclusive
  • Intact uterus
  • Last natural menstrual cycle (without exogenous hormone therapy) completed at least 12 consecutive months before screening

Exclusion criteria

  • A history or active presence of thrombophlebitis, thrombosis or thromboembolic disorders
  • A history or active presence of cerebrovascular accident, stroke, or transient ischemic attack
  • A history or active presence of malignancy, or treatment for malignancy, within the previous 10 years

Additional criteria applies.

Treatment and study plan

Bazedoxifene/Conjugate Estrogens (CE)

Drug

Raloxifene

Drug

Placebo

Drug

Primary outcomes

  1. To evaluate the effects of Bazedoxifene/Conjugate Estrogens (CE) combinations on the incidence of endometrial hyperplasia in postmenopausal women.

    Time frame: one year

Secondary outcomes

  1. To evaluate the efficacy of Bazedoxifene/CE combinations in preventing osteoporosis. To evaluate the effects of Bazedoxifene/CE combinations on vaginal atrophy, metabolic parameters, uterine bleeding, vasomotor symptoms and quality of life indices.

    Time frame: one year

Sponsors and collaborators

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Industry

Registry information

Official study title

A Double-Blind, Randomized, Placebo- and Active-Controlled Safety and Efficacy Study of Bazedoxifene/Conjugated Estrogens Combinations in Postmenopausal Women

Important dates

Study start
2002
Primary completion
2006
Study completion
2006
First posted
May 12, 2008
Registry last updated
May 12, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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