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

Completed · Phase 2

Conditions studied: Menopause, Postmenopausal Bone Loss, Breast Cancer

In brief

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.

Key facts

Study ID

NCT00165204

Run by

Dana-Farber Cancer Institute

People needed

50

Starts

2004-04-01

Expected to finish

2006-03-01

Last updated by the study team

2007-12-21

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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