Aktuelle Erfahrungen mit niedrig dosiertem Estradiol sequenziell kombiniert mit Norethisteronacetat als effektives Therapieregime bei klimakterischen Beschwerden

For women with climacteric complaints still experiencing menstrual bleedings a low-dose gestagen-emphasised preparation is indicated to treat early climacteric complaints and to reach cycle stability. The objective of this study was to document the efficacy and safety of a low-dose sequentially combined hormone replacement therapy (phase 1: 16 tablets containing 1 mg 17[3-estradiol, phase 2: 12 tablets containing 1 mg 17β-estradiol plus 1 mg norethisterone acetate) in the treatment of women with climacteric symptoms. This post marketing surveillance study is a prospective non-interfering systematic collection of data gathered during routine treatment. Assessments done by gynaecologists include bleeding profile, climacteric symptom relief, patient's/doctor's acceptance and adverse events. Result are presented of 4010 women aged 45.6 years ± 2.9, who received the sequentially combined medication for an average of 180 days. 91% of the women had regular cycles after treatment and of the women with an irregular cycle at baseline 89% regained a regular cycle after treatment. Heavy menstrual bleedings decreased from 26.3% to 3.7% and the frequency of irregular bleedings decreased from 31.1% to 9.7%. Vasomotor symptoms, sleep disorders and nervousness/irritability disappeared or improved in 95%, 89%, and 89% resp. from baseline. Less than 1% of the symptoms worsened. 91 % of the patients and 93% of the doctors rated the treatment as satisfactory. Only 2% of the study population reported one or more adverse events, most frequently irregular bleedings or strong menstrual bleedings. Low-dose estradiol sequentially combined with norethisterone acetate is proven to be effective and safe in routine treatment for women with climacteric symptoms and cycle irregularities.