There are some reports that the administration of selective estrogen receptor modulator preparations in combination with estrogen has shown suitable effects for climacteric women. This combination therapy is referred to as a tissue-selective estrogen complex. The present study was performed to elucidate whether the tissue-selective estrogen complex treatment is useful even in Japanese perimenopausal women.
Two hundred twenty-one perimenopausal women were subjected with the enough informed consent (52.6±2.5 years old). All of the participants had menopausal symptoms and wanted to take the hormone therapy (HT). Then, conjugated estrogen (0.625 mg Premarin/d) and selective estrogen receptor modulator (20 mg Bazedoxifene/d) were administered for 1 year, and the changes of the hot flushes (severe: 3, moderate: 2, mild: 1, none: 0), plasma estradiol, and NTx (type I collagen cross-linked N-telopeptide) levels and the endometrial thickness (measured by a transvaginal ultrasonic scanner) were evaluated before and during the tissue-selective estrogen complex treatment.
A significant improvement was found in the hot flushes (2.8±0.3→0.3±0.2, P<.01). Plasma NTx levels also decreased by the tissue-selective estrogen complex therapy (23.0±12.3→6.1±4.7 nmol BCE/L, P<.025). There were no significant changes in the thicknesses of the endometrium and plasma estradiol levels. No severe side effect could be seen in the tissue-selective estrogen complex treatment.
From these results, it was concluded that the tissue-selective estrogen complex treatment improves the climacteric symptoms and bone resorption marker without severe side effects in Japanese perimenopausal women. It is also suspected that the tissue-selective estrogen complex treatment may be a major HT procedure in future.