Climodien® (estradiol valerate 2 mg plus dienogest 2 mg) is safe and effective in the treatment of postmenopausal complaints

Abstract

Objective To evaluate the efficacy, safety and tolerability of continuous combined hormone replacement therapy (HRT) with Climodien® (estradiol valerate 2 mg plus dienogest 2 mg).Design Open, multinational, multicenter, non-controlled phase III study.Participants A total of 1501 women aged 52–65 years with postmenopausal symptoms of sufficient severityto require treatment.Methods Eligible patients were treated with Climodien for 12 treatment cycles (48 weeks), with assessments of efficacy, safety and tolerability (adverse events) at 8, 24and 48 weeks. Efficacy was assessed using the Kupperman index. Safety assessments included endovaginal sonography, safety endometrial biopsies, mammography, physical and gynecological examination, vitalsigns, prothrombotic factors and routine laboratory safety parameters.Results The Kupperman index improved with increasing duration of treatment, accompanied by an improvement in self-reportedpatient well-being. Individual climacteric symptoms such as hot flushes and psychonervous disorders also improved. The most pronounced improvement was seen in women who had not previously used HRT. Theincidence of breakthrough bleeding declined over time, resulting in complete amenorrhea in 86.2% of the patients after 12 cycles of treatment. Furthermore, total and low-density lipoprotein (LDL) cholesterollevels decreased and high-density lipoprotein (HDL) cholesterol levels increased. Decreases in alkaline phosphatase, pyridinoline and deoxypyridinoline demonstrated the inhibitory action of estradiol onbone resorption. Endometrial thickness remained almost constant, and the incidence of serious endometrial findings was similar to that in untreated women.Conclusions Continuous combined estrogen-progestintherapy with Climodien is effective, safe and well tolerated in postmenopausal women, with a profile and incidence of adverse events consistent with those of existing HRT preparations.