Effects of Arzoxifene on Bone Mass and the Uterus

• Status: Completed
• Trial end date: 2007-02-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purposes of this study are to determine:

• The effects of arzoxifene on bone mineral density (bone mass) at the spine and hip in postmenopausal women.

• The effects of arzoxifene on the uterus (womb) in postmenopausal women.

• The effects of arzoxifene on blood tests that measure changes in bone rebuilding in postmenopausal women with low bone density.

• The effects of arzoxifene on blood lipids (fats) and other blood markers of heart disease risk.

• The safety of arzoxifene and any side effects that might be associated with its use.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Eli Lilly and Company

Criteria

Inclusion Criteria:

• Female

• 45 to 60 years of age, inclusive

• At least 2 years since last menstrual cycle

• Intact uterus (womb).

Exclusion Criteria:

• Existing fracture of the spine.

• Bone disorders, other than low bone mass

• History of cancer in the last 5 years. Also, any history, at any time, of breast cancer or cancer of the lining of the uterus.

• Abnormal or unexplained vaginal bleeding.