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

• Published in: The European journal of contraception & reproductive health care Vol. 23; no. 6; pp. 393 - 399
• Main Authors: Cagnacci, Angelo, Bastianelli, Carlo, Neri, Manuela, Cianci, Antonio, Benedetto, Chiara, Calanni, Luana, Vignali, Michele, De Leo, Vincenzo, Cicinelli, Ettore, Borrelli, Giuseppe, Volpe, Annibale
• Format: Journal Article
• Language: English
• Published: England Taylor & Francis 02.11.2018; Taylor & Francis Ltd
• Subjects: 17β-estradiol; Adolescent; Adult; Birth control; BOLERO Study; Clinical medicine; Cohort analysis; Contraception Behavior - statistics & numerical data; Contraception continuation; Contraceptives, Oral, Combined - administration & dosage; Estradiol - administration & dosage; Female; hormonal contraception; Humans; Megestrol - administration & dosage; Menstrual Cycle - drug effects; Menstrual Cycle - psychology; menstrual cycle symptoms; Menstruation; Middle Aged; natural estrogen; Norpregnadienes - administration & dosage; Patient Satisfaction; Prospective Studies; real world; Survival analysis; Treatment Adherence and Compliance - statistics & numerical data; Womens health; Young Adult; hormonal contraception; menstrual cycle symptoms; BOLERO Study; real world; Contraception continuation; 17β-estradiol; natural estrogen
• ISSN: 1362-5187; 1473-0782
• DOI: 10.1080/13625187.2018.1541080

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.