Effects of Tibilone on Bone Density, Menopause Symptoms and Breast Density in Women After Prophylactic Oophorectomy

• Status: Completed
• Trial end date: 2006-03-01
• Target enrollment: 0
• Participant gender: Female

Summary

Women undergoing surgical menopause often experience marked menopausal side effects but are reluctant to use estrogen or other female hormones to ease the transition to menopause because of worries that the hormones may increase breast cancer risks. This study will evaluate tibolone in women experiencing surgical menopause to assess its effects on bone health, menopause symptoms and breast density.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dana-Farber Cancer Institute
• Collaborators: Beth Israel Deaconess Medical Center; Brigham and Women's Hospital; Massachusetts General Hospital; United States Department of Defense
• Treatments: Tibolone

Criteria

Inclusion Criteria:

• Good overall health

• Premenopausal at the time of enrollment if before their oophorectomy

• Will undergo or have undergone an oophorectomy

• Negative breast examination and negative breast imaging studies

Exclusion Criteria:

• History of breast cancer, ductal carcinoma in situ (DCIS) or other cancer except for carcinoma in situ of the cervix or basal cell carcinoma of the skin

• History of ovarian cancer, breast cancer (or DCIS) or other malignancy

• Low bone mass compared with age-adjusted controls

• Current or recent exposure (within 3 months) to medications that alter bone metabolism

• Estrogens, progesterones, androgens, tamoxifen or raloxifene within 3 months of randomization

• History of significant medical problems potentially related to estrogens

• History of Paget's disease of bone, ankylosing spondylitis, rheumatoid arthritis or other metabolic bone disease, vitamin D deficiency, hyperparathyroidism, or newly diagnosed hyperthyroidism

• Body mass index (BMI) > 32

• High-density lipoprotein (HDL) cholesterol < 40 mg/dl

• Women whose uterus was retained and who have a history of uterine abnormalities