Treatment continuation and satisfaction in women using combined oral contraception with nomegestrol acetate and estradiol: a multicenter, prospective cohort study (Bolero)
Carlo Bastianelli (IT), Angelo Cagnacci (IT), Manuela Neri (IT), Chiara Benedetto (IT), Luana Calanni (IT), Michele Vignali (IT), Vincenzo De Leo (IT), Giuseppe Borrelli (IT)
[Bastianelli ] La Sapienza-Università di Roma, [Cagnacci] Università degli Studi di Modena, [Neri] Azienda Ospedaliero Universitaria di Cagliari, [Benedetto] Presidio Ospedaliero Sant’Anna di Torino, [Calanni] Azienda Ospedaliera Universitaria San Martino, [Vignali] Macedonio Melloni Hospital, [De Leo] Azienda Ospedaliera Universitaria Senese, [Borrelli] Teva Italia S.r.l.
Context: The real-world experience of women receiving nomegestrol acetate (NOMAC)/estradiol (E2) is not well known. Objective: To assess treatment continuation and satisfaction of women prescribed NOMAC/E2 for contraception. Methods: This observational, non-interventional, prospective, multicenter cohort study was conducted in 17 centers in Italy. Patients: Eligible patients were premenopausal women 18-50 years old prescribed NOMAC/E2 (Zoely®, Teva Italia, Italy). Intervention: Data collected at baseline, 3 months, 6 months, and 12 months. Main Outcome Measures: The primary efficacy outcome was the number of treatment cycles completed through 12 months. Secondary outcomes included menstrual cycle-related symptoms, libido level, and treatment-related satisfaction. Adverse events (AEs) were also reported. Results: 298 women were enrolled. The mean number of NOMAC/E2 treatment days was 303.2±110.3 (median=361 days). The probability of treatment continuation through 12 months was 81% (95% confidence interval 75.6-85.2). Women reported significant improvement in menstrual cycle-related symptoms (P<0.0001), libido level (P=0.03), and treatment-related satisfaction (P<0.0001) over 12 months. Menstrual cycle-related symptoms declined from a mean of 6.2±4.4 at baseline to 2.9±3.0 at 12 months (P<0.0001). Most women reported their libido was improved or unchanged during treatment. The majority of women (52%-59%) reported improved treatment satisfaction at each time point. Treatment-related AEs were reported by 37.9% of women. Two serious AEs were reported; 1 (lymphoma) considered unrelated to treatment and 1 pregnancy. Conclusion: The real-world experience of women prescribed NOMAC/E2 indicates good treatment continuation and high satisfaction through 12 months. Other benefits included significantly improved menstrual cycle-related symptoms and maintained or improved libido.