Method for the inhibition of atrophy or for treatment or prevention of atrophy-related symptoms in women
A technology for women and compounds, applied in the field of inhibiting female atrophy or treating or preventing symptoms related to female atrophy, can solve the problem of increasing the risk of endometrial cancer and breast cancer, reducing the carcinogenicity of endometrial cancer, and not reducing breast cancer danger, etc.
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[0027] experiment
[0028] Clinical phase I-II study to investigate the effect of ospemifene on endometrial thickness, endometrial pathology (biopsy according to curettage described by Vuopala et al., 1982) in healthy postmenopausal women volunteers aged 55 to 69 years and cervical smears. Tolerability and pharmacokinetics were also assessed. Raloxifene (60 mg per day) was used as a reference. Ospemifene was administered orally in doses of 30, 60 and 90 mg per day. There were 29 volunteers at each dose level, as did the raloxifene group. Ospemifene is given as a gelatin capsule containing 30, 60 or 90 mg of ospemifene. Endometrial thickness was assessed by ultrasonography with a Hitachi EUB-405 instrument. Vaginal epithelium was assessed using the nuclear fragmentation index, an evaluation method well known to those skilled in the art. In this method, the vaginal fraction of the cervical smear is assessed as a percentage of the number of cells in the different layers: ba...
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