Objective: To investigate the effects of tibolone therapy for menopaus
al symptoms on mammographic findings and to identify any association b
etween mammographic changes and the demographic and hormonal character
istics of women receiving tibolone. Design: A prospective study. Setti
ng: A university hospital. Patient(s): Seventy-five women who were in
the climacteric or postmenopausal period were recruited, and 25 of the
m were followed up for 24 months. Intervention(s): After high-resoluti
on mammographies were performed and blood samples were collected, tibo
lone (2.5 mg/d) was administered orally to all patients. At the end of
the 24-month follow-up period, blood samples were collected again and
mammographies were repeated. Main Outcome Measure(s): Serum levels of
LH, FSH, prolactin, estradiol, testosterone, and DHEAS were determine
d from the collected samples, and mammographies were interpreted. Resu
lt(s): At the end of the 24-month follow-up period, mammographic chang
es were observed in only two women (88). Women who had no change in ma
mmography constituted group I (n = 23). Women who had a change constit
uted group II (n = 2). Although the initial hormone levels were not di
fferent, the increase in serum DHEAS in group I was significantly high
er than in group II (z = 2.30, P = 0.021). Conclusion(s): The frequenc
y of mammographic changes in women receiving tibolone therapy was foun
d to be 8% at the end of the 24-month follow-up. The serum DHEAS level
may be an important hormonal marker complementary to mammographic scr
eening for women receiving tibolone therapy. We strongly believe that
tibolone is safe in terms of mammographic changes in postmenopausal wo
men. (C) 1998 by American Society for Reproductive Medicine.