Efficacy and tolerability of the hormone replacement drug estradiol valerate/levonorgestrel in the treatment of menopausal syndrome in Thai women.

A prospective, open, single-center, uncontrolled phase IV study examined the efficacy and tolerability of a 6-month oral sequential hormone replacement therapy (estradiol valerate and levonorgestrel; Klimonorm in 50 outpatient peri- and postmenopausal Thai women. The clinical effectiveness of the drug was demonstrated by a rapid alleviation of the classical vasomotor menopausal complaints and a favorable effect on lipid metabolism. A rapid reduction in climacteric complaints ranging up to the complete absence of symptoms was achieved during the first 3 months of treatment. The positive effect on lipid metabolism was demonstrated by a clear reduction in total cholesterol and triglycerides as well as a slight reduction in the LDL fraction and a significant increase in the HDL fraction. The therapy resulted in stabilization of the cycle length. Cycles with regular withdrawal bleeding periods lasting 3 to 4 days with mostly mild intensity were restored in most of the women. The thickness of the endometrium measured sonographically did not change significantly. The drug was safe and well tolerated by most of the women. There were no clinically significant changes in body weight, blood pressure, hematological tests, and other laboratory parameters. Compliance was very good with a dropout rate due to undesirable side effects of only 5%.