Estradiol and drospirenone for climacteric symptoms in postmenopausal women: a double-blind, randomized, placebo-controlled study of the safety and efficacy of three dose regimens

METHOD: A randomized, placebo-controlled trial was conducted to evaluate the safety and efficacy of drospirenone (1, 2 or 3 mg) combined with estradiol (1 mg) in the treatment of climacteric symptoms in healthy postmenopausal women. RESULTS: The frequency of hot flushes was significantly decreased in all treatment groups (range 86-90%) in comparison to placebo (45%, p < or = 0.001) and remained suppressed at 16 weeks. Treatment with drospirenone and estradiol also decreased the intensity and severity of sweating, sleep problems, depression, nervousness, and urogenital symptoms. Most adverse events were mild or moderate, with similar rates observed in all groups. No serious adverse events or clinically significant laboratory abnormalities attributed to treatment occurred. CONCLUSION: These results demonstrate that the combinations of 1, 2, and 3 mg drospirenone with 1 mg estradiol are safe and effective for the treatment of climacteric symptoms.