Status:
COMPLETED
Effects of Tibilone on Bone Density, Menopause Symptoms and Breast Density in Women After Prophylactic Oophorectomy
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
Brigham and Women's Hospital
Beth Israel Deaconess Medical Center
Conditions:
Menopause
Postmenopausal Bone Loss
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief 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 th...
Detailed Description
Women interested in participating in this study will be allowed to use hormones to manage symptoms for up to 3 months before beginning the study. Those choosing not to take hormones may enroll in the ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
End Date :
March 1 2006
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00165204
Start Date
April 1 2004
End Date
March 1 2006
Last Update
December 21 2007
Active Locations (3)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
2
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
3
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215