Cem Batukan1, Iptisam Ipek Muderris. 1. Department of Obstetrics and Gynecology, Erciyes University, School of Medicine, Kayseri, Turkey. cbatukan@erciyes.edu.tr
Abstract
OBJECTIVE: This study represents long term clinical and biochemical results and the response of different body parts to medical therapy with oral ethinyl estradiol/drospirenone combination in hirsute patients with or without polycystic ovary syndrome (PCOS). DESIGN: Prospective, open, controlled clinical study. SETTING:Outpatients at Erciyes University Medical School. PATIENT(S): Fifty women with moderate to severe hirsutism were recruited. Two women were lost to follow-up. INTERVENTION(S): Women were treated with 3 mg of drospirenone and 30 microg of ethinyl estradiol for 12 cycles. MAIN OUTCOME MEASURE(S): Hirsutism was assessed at 6-month intervals using the Ferriman-Gallwey (F-G) scoring system. Serum FSH, LH, total and free testosterone (T), androstenedione (A), dehydroepiandrosterone sulfate (DHEAS), estradiol (E2), and sex-hormone binding globulin (SHBG) levels at 6 and 12 months of therapy were compared with baseline values. RESULT(S): Total mean FG score declined by 67% and 78% after 6 and 12 months, respectively. Improvement was most prominent on the chest and abdomen, followed by the upper lip and chin. The lowest effect was observed on the back and arms. Serum levels of total and free T and A decreased, whereas SHBG levels increased significantly after 6 and 12 months when compared with baseline levels. CONCLUSION(S): Drospirenone/ethinyl estradiol combination exerts significant antiandrogenic activity and is effective in improving facial hirsutism. The beneficial effect is most obvious after six cycles and continues thereafter at a slower rate.
RCT Entities:
OBJECTIVE: This study represents long term clinical and biochemical results and the response of different body parts to medical therapy with oral ethinyl estradiol/drospirenone combination in hirsute patients with or without polycystic ovary syndrome (PCOS). DESIGN: Prospective, open, controlled clinical study. SETTING: Outpatients at Erciyes University Medical School. PATIENT(S): Fifty women with moderate to severe hirsutism were recruited. Two women were lost to follow-up. INTERVENTION(S): Women were treated with 3 mg of drospirenone and 30 microg of ethinyl estradiol for 12 cycles. MAIN OUTCOME MEASURE(S): Hirsutism was assessed at 6-month intervals using the Ferriman-Gallwey (F-G) scoring system. Serum FSH, LH, total and free testosterone (T), androstenedione (A), dehydroepiandrosterone sulfate (DHEAS), estradiol (E2), and sex-hormone binding globulin (SHBG) levels at 6 and 12 months of therapy were compared with baseline values. RESULT(S): Total mean FG score declined by 67% and 78% after 6 and 12 months, respectively. Improvement was most prominent on the chest and abdomen, followed by the upper lip and chin. The lowest effect was observed on the back and arms. Serum levels of total and free T and A decreased, whereas SHBG levels increased significantly after 6 and 12 months when compared with baseline levels. CONCLUSION(S): Drospirenone/ethinyl estradiol combination exerts significant antiandrogenic activity and is effective in improving facial hirsutism. The beneficial effect is most obvious after six cycles and continues thereafter at a slower rate.