Effect on quality of life of switching to combined oral contraception based on natural estrogen: an observational, multicentre, prospective phase IV study (ZOCAL Study)
Por:
Lete I, de la Viuda E, Pérez-Campos E, Martínez MÁ, Sanchez-de la Rosa R, Novalbos J and Sánchez-Borrego R
Publicada:
1 ago 2016
Resumen:
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.
Filiaciones:
Lete I:
a Department of Obstetrics and Gynaecology , Araba University Hospital , Vitoria-Gasteiz , Spain
de la Viuda E:
b Department of Obstetrics and Gynaecology , University Hospital of Guadalajara , Guadalajara , Spain
:
c Department of Obstetrics and Gynaecology , Hospital General de Requena , Valencia , Spain
Martínez MÁ:
d Centro de Salud Sexual y Reproductiva Alicante III , Alicante , Spain
Sanchez-de la Rosa R:
e Teva Pharma Medical Affairs , Madrid , Spain
Novalbos J:
e Teva Pharma Medical Affairs , Madrid , Spain
Sánchez-Borrego R:
f DIATROS, Clínica de Atención a la Mujer , Barcelona , Spain
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