Effect on quality of life of switching to combined oral contraception based on natural estrogen: an observational, multicentre, prospective phase IV study (ZOCAL Study)

• Published in: The European journal of contraception & reproductive health care Vol. 21; no. 4; pp. 276 - 284
• Main Authors: Lete, Iñaki, de la Viuda, Esther, Pérez-Campos, Ezequiel, Martínez, María Ángeles Gómez, Sanchez-de la Rosa, Rainel, Novalbos, Jesús, Sánchez-Borrego, Rafael
• Format: Journal Article
• Language: English
• Published: England Taylor & Francis 01.08.2016; Taylor & Francis Ltd
• Subjects: Adolescent; Adult; Birth control; Combined oral contraception; Condoms - utilization; Contraceptives, Oral, Combined - adverse effects; Contraceptives, Oral, Combined - therapeutic use; E2V/DNG; Estrogens; Ethinyl Estradiol - adverse effects; Ethinyl Estradiol - therapeutic use; Female; Humans; Megestrol - adverse effects; Megestrol - analogs & derivatives; Megestrol - therapeutic use; Metrorrhagia - chemically induced; Middle Aged; Nandrolone - adverse effects; Nandrolone - analogs & derivatives; Nandrolone - therapeutic use; natural estrogen; NOMAC/E2; Patient Satisfaction; Premenstrual Syndrome - chemically induced; Prospective Studies; Quality of Life; Reproductive health; Womens health; Young Adult; Combined oral contraception; natural estrogen; quality of life; E2V/DNG; NOMAC/E2
• ISSN: 1362-5187; 1473-0782
• DOI: 10.3109/13625187.2016.1174206

Objectives: This observational, multicentre, prospective phase IV study examined change in health-related quality of life (QOL) from baseline to 6 months in women initiating combined oral contraception (COC) based on natural estrogen. Methods: Eligible women attending a baseline and 6-month gynaecology appointment belonged to one of three groups: group 1 used barrier contraception (condoms) and elected to continue this method; group 2 used condoms and elected to switch to COC based on natural estrogen; group 3 used COC based on ethinylestradiol and elected to switch to COC based on natural estrogen. The Spanish Society of Contraception (SEC)-QOL scale assessed health-related QOL. Secondary outcomes included symptoms of premenstrual syndrome, intermenstrual bleeding, duration and intensity of menstrual bleeding, contraception continuation rate, and tolerability. Results: A total of 857 women were enrolled and 785 completed the study. Group 2 (n = 224 completed) had significantly lower SEC-QOL global and dimension scores at baseline and significantly greater increases in SEC-QOL from baseline to 6 months compared with groups 1 (n = 72) and 3 (n = 489). Group 3 reported a similar SEC-QOL score to that of group 1 at baseline but showed significantly greater improvement in SEC-QOL global and psychological scores from baseline to 6 months. Among women receiving COC based on natural estrogen, the contraception continuation rate was 713/780 (91.4%); treatment-related adverse events were reported by 13/780 (1.7%). Conclusions: Improved SEC-QOL after 6 months was found in women who were dissatisfied with their current contraception at baseline and chose to switch to COC based on natural estrogen.