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

Osteoporosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00675688
• Other study ID #: 3115A1-303
• Status: Completed
• Phase: Phase 3
• First received: May 7, 2008
• Last updated: May 9, 2008
• Start date: April 2002
• Est. completion date: January 2006

Study information

• Verified date: May 2008
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3544
• Est. completion date: January 2006
• Est. primary completion date: January 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Endometrial Hyperplasia
• Hyperplasia
• Osteoporosis

Intervention

Drug:
• Bazedoxifene/Conjugate Estrogens (CE)

• Raloxifene

• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the effects of Bazedoxifene/Conjugate Estrogens (CE) combinations on the incidence of endometrial hyperplasia in postmenopausal women.		one year	Yes
Secondary	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.		one year	Yes