Hormonal replacement therapy based on the transdermal estradiol and intravaginal progesterone – evaluation of efficacy and tolerability

The aim of the present study was to assess the efficacy and tolerability during HRT with the use of transdermal estradiol and progesterone in vaginal tablets.
Fourty one women aged 44–59 were recruited for HRT including transdermal estradiol (40 mcg/24 h; Estroplast, Adamed) and vaginal micronized progesterone tablets (50 mg bd; Luteina, Adamed) in either sequential (25 women) or continuous regimen (17 patients). The patients were followed-up for 3 months for the quality of life improvement (Greene Climacteric Scale and SSA-P questionnaire were used), blood lipids, bleeding pattern and ultrasonographic appearance of endometrium.
The quality of life significantly improved after 4 weeks of therapy with further improvement observed in the following 2 months of HRT. After 3 months of therapy, a significant decline in total cholesterol and LDL levels was observed with unchanged HDL level. After 3 months of treatment the median endometrial thickness was 4.3 mm (range 2.0–7.6 mm) and did not differ significantly from the baseline value. In none of the patients sonographic abnormalities were found in endometrium after 3 months of treatment. 5 out of 17 patients receiving combined continuous therapy (29.4%) reported spotting episodes during the first month of therapy. Two of those patients stopped HRT due to the intolerance of spotting/bleeding. In the remaining 3 patients bleeding episodes had a tendency to shorten or disappear in the 2nd and 3rd treatment cycle and they formed no reason for HRT discontinuation. Of the 25 patients who received sequential HRT, none reported abnormal bleeding during the observation period (the average duration of withdrawal bleeding was 4.0 days).
Conclusions: HRT based on transdermal E2 and vaginal P results in the significant improvement of the quality of life and favorable changes of the blood lipids profile. Progesterone containing vaginal tablets (50 mg bd) provides an effective endometrial protection during estrogen replacement therapy.