Abstract
PURPOSE: Polycystic ovarian syndrome (PCOS) is a common endocrine-metabolic disorder affecting about 10% of reproductive-age women. Characterized by hyperandrogenism and ovulatory dysfunction, PCOS often involves metabolic features due to insulin resistance. Traditional treatment with combined oral contraceptive pills (COCP) effectively manages hyperandrogenism and menstrual irregularities. However, drospirenone-only pills (DRSP) may offer a viable alternative for patients who cannot take estrogen-based contraceptives due to cardiovascular risks or personal preference, owing to drospirenone's antiandrogenic properties and improved bleeding profile. This study aimed to evaluate the effects of DRSP-only pills on hyperandrogenism in PCOS patients. Secondary objectives included assessing changes in metabolic and hormonal features and bleeding profiles during therapy. MATERIALS AND METHODS: This monocentric observational retrospective study included 25 hyperandrogenic PCOS patients, aged 16 to 35, treated at Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome. Patients were prescribed DRSP-only therapy for 6 months. Clinical evaluations included ultrasonography, hormonal assays, and dermatological assessments using the Comprehensive Acne Severity Scale (CASS) and the modified Ferriman-Gallwey (mFG) score. Statistical analysis was performed using the two-tailed Wilcoxon test, with significance set at p < 0.05. RESULTS: After 6 months of DRSP-only therapy, there was a significant reduction in CASS scores (2.4-1.8, p = 0.02) and mFG scores (12.31-6.31, p = 0.0053). In addition, significant reductions in 17-OH-progesterone (0.6-0.3 ng/ml, p = 0.03) and basal LH levels (5.8-3.55 UI/ml, p = 0.01) were observed. A trend toward a reduction in CRP levels (1.6-0.5 mg/l, p = 0.06) was noted. Any worsening in metabolic parameters was noted. Bleeding patterns were consistent with literature, with initial spotting decreasing over time. CONCLUSIONS: This study showed that a 6-month drospirenone (DRSP)-only therapy significantly reduced hyperandrogenism symptoms, such as acne and hirsutism, in PCOS patients. It also lowered 17-OH-progesterone levels and showed a trend of reduced CRP values. Bleeding patterns were consistent with those in existing literature. We recommend DRSP-only therapy as a suitable option for PCOS patients with hyperandrogenism who cannot use combined oral contraceptives (COCs), as well as to minimize the metabolic risks of estrogen.