What is tibolone (Livial)?

Authors:

Doren M. Rubig A. Coelingh Bennink HJT. Holzgreve W.

Institution:

Dr. M. Doren, Free University of Berlin, Benjamin Franklin Univ. Hospital, Clinical Research Center, Klingsorstrasse 109a, D-12203 Berlin; Germany.

Title:

Differential effects on the androgen status of postmenopausal women treated with tibolone and continuous combined estradiol and norethindrone acetate replacement therapy (2001-3251).

Source:

Fertility and Sterility. Vol 75(3) (pp54-559), 2001.

Abstract:

Objectives:

To determine serum parameters reflective of androgen status in postmenopausal women using two types of hormone replacement therapy (HRT).

Design:

Randomized, double-blind, prospective 1-year trial of two oral HRT regimens.

Setting:

University hospital, department of obstetrics and gynecology, menopause clinic.

Patients:

100 postmenopausal women >= 45 years. Intervention(s): Daily use of the progestogen tibolone (2.5 mg; n = 50) or continuous combined 17-beta-estradiol (2 mg) and norethindrone acetate (E+NA, 1 mg; n = 50).

Main Outcome Measure(s):

Measurements of total testosterone (total T), dehydroepiandrosterone sulfate (DHEAS), androstenedione (A), FSH, and sex-hormone-binding globulin (SHBG), and calculations of free testosterone (free T). Assessment of changes from baseline within and between groups after 6 and 12 months.

Results:

We found significant differences (% changes) in the tibolone group compared to baseline within the groups after both 6 and 12 months, respectively. Levels of free T doubled, total T decreased slightly, and SHBG decreased by half; DHEAS increased by approximately 20%; and FSH decreased. In the E+NA group, levels of free T, total T, androstenedione, and FSH all decreased, and SHBG increased. Pre-trial levels of DHEAS, A, and total T were significantly higher in the E+NA group. Between groups throughout the study, the changes from baseline were significant due to the different extent of FSH reduction, and opposite changes of free T, SHBG, and DHEAS.

Conclusion(s):

Both regimens modify plasma androgens, DHEAS, and SHBG differently. Tibolone decreased the levels of SHBG, and substantially increased free T and to a lesser extent increased DHEAS; this may reflect a modification of adrenal androgen production. Continuous combined estradiol and norethindrone acetate HRT suppressed the peripheral plasma androgens mediated by increased levels of SHBG. Copyright (copyright) 2001 American Society for Reproductive Medicine.

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