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2002•Menopause The Journal of The North American Menopause SocietyRequires access

Formation of 7??-methyl-ethinyl estradiol during treatment with tibolone

Inka Wiegratz, Nicole S nger, Herbert Kühl

Open publisher page 32 citations

Abstract

OBJECTIVE: To investigate whether tibolone, which is orally used for hormone replacement therapy, is transformed to a derivative of ethinyl estradiol (EE). DESIGN: In 10 young women who received 2.5 mg orally administered tibolone daily between cycle day 19 and 25, blood was obtained before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 h after the last tablet intake. The concentration of 7 alpha-methyl-EE was determined by the gas chromatography with mass spectrometry method. RESULTS: The results demonstrate that, during daily treatment of women with 2.5 mg tibolone, a small proportion of tibolone is transformed to 7 alpha-methyl-EE. The maximal serum concentrations of 125 +/- 40 pg/mL were in the range of the levels of EE observed during treatment with oral contraceptives containing 30 microg EE. CONCLUSIONS: Caution is advisable when considering treatment with tibolone of postmenopausal women with contraindications for estrogens.

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What this paper is about

OBJECTIVE: To investigate whether tibolone, which is orally used for hormone replacement therapy, is transformed to a derivative of ethinyl estradiol (EE). DESIGN: In 10 young women who received 2.5 mg orally administered tibolone daily between cycle day 19 and 25, blood was obtained before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 h after the last tablet intake. The concentration of 7 alpha-methyl-EE was determined by the gas chromatography with mass spectrometry method. RESULTS: The results demonstrate that, during daily treatment of women with 2.5 mg tibolone, a small proportion of tibolone is transformed to 7 alpha-methyl-EE. The maximal serum concentrations of 125 +/- 40 pg/mL were in the range of the levels of EE observed during treatment with oral contraceptives containing 30 microg EE. CONCLUSIONS: Caution is advisable when considering treatment with tibolone of postmenopausal women with contraindications for estrogens.

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Available abstract

OBJECTIVE: To investigate whether tibolone, which is orally used for hormone replacement therapy, is transformed to a derivative of ethinyl estradiol (EE). DESIGN: In 10 young women who received 2.5 mg orally administered tibolone daily between cycle day 19 and 25, blood was obtained before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 h after the last tablet intake. The concentration of 7 alpha-methyl-EE was determined by the gas chromatography with mass spectrometry method. RESULTS: The results demonstrate that, during daily treatment of women with 2.5 mg tibolone, a small proportion of tibolone is transformed to 7 alpha-methyl-EE. The maximal serum concentrations of 125 +/- 40 pg/mL were in the range of the levels of EE observed during treatment with oral contraceptives containing 30 microg EE. CONCLUSIONS: Caution is advisable when considering treatment with tibolone of postmenopausal women with contraindications for estrogens.

Key concepts: Tibolone, Medicine, Ethinylestradiol, Internal medicine, Hormone, Hormone replacement therapy (female-to-male), Endocrinology, Postmenopausal women

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