Impact of a New Formulation of Low-Dose Micronised Medroxyprogesterone and 17-beta Estradiol on Lipid Profiles in Menopausal Women.

OBJECTIVE

To evaluate the impact of cyclical low-dose micronised medroxyprogesterone (5 mg/day for the last 12 days of each 28-day cycle) in combination with 17-beta estradiol (2 mg/day continuously) on lipid profiles in postmenopausal women treated for 12 months.

METHODS

Open, noncomparative, prospective study carried out in general practice.

RESULTS

98 female patients were enrolled; seven failed to meet entry criteria, 20 withdrew after developing adverse events, three were lost to follow up and one withdrew for personal reasons; 67 (67.3%) completed 12 months' treatment. Levels of total cholesterol (6.42 mmol/L at baseline) fell 8.4% (p = 0.0001) after 12 months' treatment, while total triglycerides (1.39 mmol/L at baseline) increased by 12.2% (p = 0.007), low density lipoprotein cholesterol (4.27 mmol/L at baseline) fell 18.3% (p = 0.0001) and high density lipoprotein (HDL) cholesterol (1.59 mmol/L at baseline) increased by 6.9% (p = 0.0001). The most frequently reported adverse events were menorrhagia, breast tenderness, cervical polyps or cysts, bloating, fatigue or lethargy, influenza or influenza-like syndrome, back pain and headaches.

CONCLUSIONS

Treatment with oral micronised 17-beta estradiol 2 mg/day continuously and medroxyprogesterone 5 mg/day for 12 days of each 28-day cycle lead to changes in lipid profiles in postmenopausal women that had favourable implications for the risk of development of coronary heart disease. The 17-beta estradiol-induced increase in the level of HDL cholesterol was maintained during combination with low-dose cyclical medroxyprogesterone for 12 months.