Clinical trial · Interventional
Effects of Tibilone on Bone Density, Menopause Symptoms and Breast Density in Women After Prophylactic Oophorectomy
A Randomized Study of the Effects of Tibolone on Bone Density, Menopause Symptoms and Breast Density in High Risk Women After Prophylactic Oophorectomy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Menopause | — | UNRESOLVED | — |
| Postmenopausal Bone Loss | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tibolone | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- To compare bone mineral density and markers of bone turnover following oophorectomy in patients receiving tibolone versus placebo
Secondary outcomes (1)
- measure
- To compare changes in menopausal symptoms and mammographic breast density in women taking tibolone to women taking placebo
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDMcCauley LS, Ghatas MP, Sumrell RM, Cirnigliaro CM, Kirshblum SC, Bauman WA, Gorgey AS. Measurement of Visceral Adipose Tissue in Persons With Spinal Cord Injury by Magnetic Resonance Imaging and Dual X-Ray Absorptiometry: Generation and Application of a Predictive Equation. J Clin Densitom. 2020 Jan-Mar;23(1):63-72. doi: 10.1016/j.jocd.2018.12.003. Epub 2018 Dec 15. PMID 30638769