A randomized, double-blind, placebo-controlled, multicentre study to evaluate the effect of a 12-week

INTERVENTION: Trade Name: Biosteron 10 mg, Biosteron 25 mg Product Name: DHEA Product Code: PR1‐888‐2022; PR2‐888‐2022 Pharmaceutical Form: Tablet Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use CONDITION: Menopause Therapeutic area: Health Care [N] ‐ Population Characteristics [N01] PRIMARY OUTCOME: Main Objective: Demonstration that 12‐week supplementation with 35 mg DHEA improves quality ; of life and reduces symptoms of vaginal atrophy.; Demonstration that DHEA supplementation at a dose of 35 mg improves mood and reduces the ; severity of vasomotor symptoms associated with menopause. Primary end point(s): Demonstration that 12 weeks of supplementation with 35 mg DHEA improves quality of sexual ; life and reduces symptoms of vaginal atrophy.; Demonstration that DHEA supplementation at a dose of 35 mg improves mood and reduces the ; severity of vasomotor symptoms associated with menopause. Secondary Objective: Demonstration that DHEA supplementation in a dose of 35 mg affects the ; concentration of DHEA and estradiol. Timepoint(s) of evaluation of this end point: N/A SECONDARY OUTCOME: Secondary end point(s): Demonstration that 35 mg DHEA supplementation ; affects serum levels of LH, DHEAS and estradiol Timepoint(s) of evaluation of this end point: N/A INCLUSION CRITERIA: ‐ woman, ‐BMI 20.0‐29.9 kg / m2, ‐ time from the last menstruation at least 12 months, ‐stable body weight during the last 6 months, ‐ FSH concentration 35‐135 mIU / ml and estradiol 5‐55 pg / ml, ‐ concentration of total testosterone 0.084 ‐ 0.481 ng / ml, ‐ Beck Depression Score 11–27 points, ‐ result in the Kupperman Scale 17‐30 points, ‐ declared sexual activity, ‐ FSFI scale ‐ not using menopausal replacement therapy for at least 6 months, ‐ The ability to understand audit procedures and provide written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range