Treatment continuation and satisfaction in women using combined oral contraception with nomegestrol acetate and oestradiol: a multicentre, prospective cohort study (BOLERO). (2nd November 2018)

• Record Type: Journal Article
• Authors: Cagnacci, Angelo; Bastianelli, Carlo; Neri, Manuela; Cianci, Antonio; Benedetto, Chiara; Calanni, Luana; Vignali, Michele; De Leo, Vincenzo; Cicinelli, Ettore; Borrelli, Giuseppe; Volpe, Annibale
• Is Part Of: European journal of contraception & reproductive health care. Volume 23:Number 6(2018)
• Page Start: 393
• Page End: 399
• Publication Date: 2018-11-02
• Subjects: Contraception continuation -- 17β-estradiol -- BOLERO Study -- hormonal contraception -- menstrual cycle symptoms -- natural estrogen -- real world; Contraception -- Periodicals; Reproductive health -- Periodicals; Generative organs, Female -- Periodicals; Contraception -- Periodicals; Reproductive Medicine -- Periodicals; 613.9
• DOI: 10.1080/13625187.2018.1541080
• Languages: English
• ISSNs: 1362-5187

Abstract

Abstract: Objective: The aim of the study was to examine treatment continuation and satisfaction over 1 year among women receiving nomegestrol acetate (NOMAC)/oestradiol (E2) combined oral contraception (COC) in real-world clinical practice. Methods: The 17β-Estradiol and Nomegestrol Acetate (BOLERO) Study is an observational, non-interventional, prospective, multicentre cohort study of premenopausal women (aged 18–50 years) who received prescription NOMAC/E2 (2.5 mg/1.5 mg) for contraception during routine clinical practice. Assessments were carried out at enrolment and at 3, 6 and 12 months. Probability of treatment continuation through 12 months (primary outcome) was examined using Kaplan–Meier survival analysis. Secondary outcomes included treatment satisfaction, menstrual cycle-related symptoms, libido and adverse events (AEs). Results: Of 298 enrolled women, 292 were evaluable. The probability of NOMAC/E2 continuation through 12 months was 73.7% (95% confidence interval [CI] 68.0%, 78.5%). Satisfaction with NOMAC/E2 increased from 56.9% (37/65) of women at initial evaluation to 89.2% (58/65) of women at 12 months. Physician ratings at 12 months showed satisfactory to very satisfactory in 84.0% (168/200) of women. Libido was not affected. Menstrual cycle-related symptoms significantly declined from enrolment (6.04 ± 4.32) to 3 months (3.25 ± 3.05) and 12 months (2.62 ± 2.74; p < .0001). Treatment-related AEs were reported by 38.7% (113/292) of women. Conclusion: The real-world experience of women receiving NOMAC/E2 indicated very good treatment continuation, high satisfaction and significantly improved menstrual cycle-related symptoms.