Introduction

The treatment of choice in women with polycystic ovarian syndrome (PCOS) who do not wish to conceive are combined oral contraceptives (COCs). The estrogen and progestin act together to suppress the gonadotropin secretion, resulting in a decreased ovarian steroidogenesis. There are few studies on the usage of COC comprising of 30 µg of ethinylestradiol (EE) and 3 mg of drospirenone (DRSP) in the treatment of PCOS. Several studies have demonstrated the anti-androgenic effects of DRSP as well as the favourable metabolic effects like reduction in blood pressure and body weight. The current study evaluated the effect of this combination on clinical, endocrine and metabolic indices of women with PCOS.

Aim

To assess the efficacy of COC containing 30 µg of EE and 3 mg of DRSP in the treatment of hyperandrogenism associated with PCOS.

Method

Study design

• Prospective open study
• The study recruited 20 women with PCOS out of which 15 had hirsutism and oligomenorrhea while 5 had only hirsutism
• The patients were assessed for the grade of hirsutism using Ferriman-Gallwey (F-G) score
• The parameters like body mass index (BMI), waist/hip ratio (WHR), serum levels of testosterone, sex-hormone binding globulin (SHBG), immune reactive insulin (IRI), glucose, free androgenic index, and insulin resistance (HOMA-IR) were also measured
• Patients received COC containing EE and DRSP from day 1 of their menstruation cycle for 21 days, followed by tablet-free interval of 7 days
• The treatment was carried out for 6 cycles

End Points

• Change in testosterone level
• Changes in BMI and WHR
• Change in F-G score
• Change in values of SHBG
• Carbohydrate metabolism

Results

• Good cycle control was achieved in all the patients
• 20% reported breakthrough bleeding/spotting during the first cycle and 15% reported these disturbances in atleast one of the cycles
• The drug was well tolerated and accepted by the patients
• There was a significant mean difference of -1.03 nmol/lt  in the level of testosterone at the end of 6 cycles (p=0.0104)
• The levels of SHBG at the end of 6 cycles were almost three times more than that at baseline, resulting in a decreased FAI
• The F-G scores were compared and it was found that hirsutism was lower in 80% whereas 20% found no change
• The mean F-G score was reduced by 23% at the end of the study period, with a mean difference of -2.55 as compared to baseline (p=0.0159)
• The changes in carbohydrate metabolism assessed by measurements of blood glucose, IRI and HOMA-IR were not significant.

Conclusion

• Treatment with COC containing 30 µg of EE and 3 mg of DRSP was effective in reducing the hyperandrogenic effects in women with PCOS
• This combination was well tolerated and can be a good option in PCOS women who do not wish to conceive

Eur J Contracept Reprod Health Care. 2007 Mar;12(1):30-5.