Therapeutic non-contraceptive properties of the drug containing ethinylestradiol 0.03 mg and drospirenone 3 mg

Abstract

Aim. To compare effects of the drug containing ethinylestradiol (EE) 0.03 mg and drospirenone (DRSP) 3 mg and the drug containing EE 0.02 mg and DRSP 3 mg on the skin and anthropometric parameters. Materials and methods. A prospective comparative randomized study included 40 women of reproductive age who didn’t have contraindications to use of combined oral contraceptive (COCs). The first group consisted of 20 women who were administrated EE 0.03 mg and DRSP 3 mg in the 21/7 regimen according to a prescribing information; the 2nd group included 20 patients who were administrated EE 0.02 mg and DRSP 3 mg in the 24/4 regimen according to a prescribing information. The study protocol included 8 visits: at the 0th visit, the inclusion and exclusion criteria were evaluated, at the 1st visit patient were randomized (envelope method) to receive one or another drug, at the 2nd - 7th visits (once a month) blood pressure was measured, anthropometric parameters were determined including body weight, height, waist, hips as well as body mass index, a degree of hirsutism (with Ferriman-Gallwey scale), skin and hair skin oiliness, acne (with a 10-point visual scale) were evaluated. Results. The use of EE 0.03 mg and DRSP 3 mg for 6 months did not significantly affect the body weight and body mass index, waist and hips. In the 6th month, the use of EE 0.03 mg and DRSP 3 mg lead to a statistically significant decrease in skin oiliness, severity of acne and hirsutism, which was comparable to a clinical effectiveness of EE 0.02 mg and DRSP 3 mg. Conclusions. EE 0.03 mg and DRSP 3 mg has a similar effect on skin oiliness, severity of acne and hirsutism with EE 0.02 mg and DRSP 3 mg, without significantly affecting the main anthropometric parameters. It is likely that the effect of DRSP-containing COCs on androgen levels and adipose tissue is due precisely to the effect of DRSP, and not to the dose of EE.