Clinical responses to the combination of estradiol and drospirenone in symptomatic postmenopausal Thai women.

OBJECTIVES To investigate the efficacy and tolerability of the oral hormone replacement therapy (HRT) containing 1 mg estradiol (E2) plus 2 mg drospirenone (DRSP) in Thai women with postmenopausal symptoms. MATERIAL AND METHOD Fifty-five Thai women with postmenopausal symptoms participated in this multicenter, open-label, non-comparative Phase IV study. The primary endpoint was the reduction of hot flushes after 12 weeks of treatment. Secondary endpoints included changes infrequency and intensity of menopausal symptoms as well as safety assessments after 4, 8, and 12 weeks of treatment. RESULTS Treatment with 1 mg E2 plus 2 mg DRSP reduced the frequency of hot flushes in 94.6% of women at the end of the 12-week treatment period. In 60% of women, the frequency of hot flushes was reduced to 10% or less, compared to baseline findings and 49.1% of women had no remaining hot flushes. Other postmenopausal symptoms such as vaginal dryness, urinary incontinence, dysuria, and dyspareunia improved The most common adverse events were vaginal bleeding or spotting and breast tenderness. CONCLUSION The oral HRT of 1 mg E2 plus 2 mg DRSP was effective and well tolerated by Thai women suffering from postmenopausal symptoms.