A pilot study of hormone replacement therapy with tibolone in women with mastopathic breasts

• Published in: Maturitas 2001-11, Vol.40 (2), p.165-171
• Main Authors: Egarter, Christian, Eppel, Wolfgang, Vogel, Sonja, Wolf, Georg
• Format: Article
• Language: English
• Subjects: Biological and medical sciences; Breast - drug effects; Breast - pathology; Double-Blind Method; Female; Hormone Replacement Therapy; Hormones. Endocrine system; Humans; Mammography; Medical sciences; Middle Aged; Norpregnenes - administration & dosage; Norpregnenes - pharmacology; Pharmacology. Drug treatments; Pilot Projects; Postmenopausal women; Postmenopause; Prospective randomized double-blind pilot study; Prospective Studies; Tibolone; Treatment Outcome
• ISSN: 0378-5122; 1873-4111
• DOI: 10.1016/S0378-5122(01)00235-3

Objective: Our purpose was to investigate the effect of tibolone in a prospective randomized, double-blind pilot study in postmenopausal women with clinically palpable mastopathic changes. Methods: Twenty postmenopausal non-users of hormone replacement therapy undergoing mammography were randomly allocated to receive either 2.5 mg tibolone (Livial®, Organon) or placebo (2 mg lactose). Mammographic density according to the Wolfe classification, severity of breast discomfort, parity, smoking habits, body weight and follicle-stimulating hormone (FSH) and estradiol (E 2) levels were documented at baseline and after 6 months of treatment. Results: There were no statistically significant differences between the two treatment groups in terms of parity, smoking, body weight and FSH and E 2 levels. At 6 months, four patients in the tibolone group showed reduced breast density, compared with one patient in the placebo group. Whereas no significant differences were found between the two treatment groups when the categories ‘minimal reduction’ and ‘reduction’ in mammographic density were combined, combination of the categories ‘no change’ and ‘minimal reduction’ showed a significant difference ( P