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Tibolone (INN, USAN, BAN) (brand name Livial, Tibofem), also known as 7α-methyl norethindrone, is a synthetic steroid with estrogen, progesterone and weak androgenic effects, introduced in 1988 , Widely used in Europe, Asia, Oceania, in addition to the United States (not available), the rest of the world. It is mainly used for the treatment of endometriosis, as well as postmenopausal women hormone replacement therapy. Compared with the elderly hormone replacement, tibolone has similar or higher efficacy, but with similar side effects. It was also investigated for possible treatment of female sexual dysfunction.
Tibolone is a 19-norepinephrine derivative associated with other 19-norepinephrine progesterone structures. It is a 7α-methyl derivative of noretynodrel.
Tibolone is a relatively new postmenopausal woman whose structure is associated with 19-norepinephrine derivatives and has weak estrogen, progesterone and androgen activity. The effect of tibolone on breast tissue remains unclear. In vitro studies have shown conflicting results of the effects of tibolone on breast cells. On the other hand, although epidemiological studies have shown an increase in the risk of breast cancer in women treated with tibolone, the accumulation of data from radiological studies has shown promising results. However, the need for further study of tibolone on the safety of breast tissue, in particular through careful design, large-scale randomized controlled trials.
Menopausal-related symptoms can affect many women's QoL. More than 75% of postmenopausal women undergo hot flashes and sweat. Other symptoms such as insomnia, headache or fatigue, as well as changes in mood and libido, may come directly from menopause or indirectly, such as the effect of hot flashes on sleep disorders. Throughout the menopause, the decline in ovarian steroid production is associated with nutritional changes in various neurotransmitters and neuropeptides, and estrogen administration improves. Estrogen administration not only has a positive effect on vascular instability, thereby reducing the number and intensity of hot flashes and sweats, and it seems to improve menopausal psychological disorders such as depression, sexual and emotional behavioral disorders.
The effect of estrogen on the mood of postmenopausal women is mainly related to the direct effect of estrogen on neurological activity and adrenaline, dopaminergic and serotonin ability regulation. This estrogenic effect also increases the role of drugs acting on serotonin, such as selective serotonin reuptake inhibitors (SSRI)
There is no data on the direct effect of tibolone on central neurotransmitter levels. However, tibolone did not enhance the antidepressant effect of SSRI fluoxetine in a group of postmenopausal women with severe depression
Estrogen directly regulates the activity of endogenous opioids, directly stimulating the expression of opioid receptors and by acting on opioid pathways. The cyclic modification of erythropoietin (Ep) levels can be thought to be a marker of neuroendocrine function. In postmenopausal women surgery or spontaneous postmenopausal, plasma beta-Ep levels have been detected, and this reduction is thought to play a role in the mechanism of hot flashes and sweat seizures. The decrease in plasma beta-Ep levels is also associated with the onset of mood, behavior and the pathogenesis of nociceptive disorders. In fact, the positive effect of HRT on vasomotor and subjective psychosomatic symptoms may be mediated by the action of the anvastatin pathway. In fact, oral estrogen replacement therapy (ERT) spontaneously or surgically induced menopause after circulating beta-endorphin levels increased significantly. Oral administration of tibolone in rat ovariectomized rats has been shown to increase the levels of beta-endorphins in pituitary and plasma similarly to administration of estradiol benzoate.
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