Abstract
BackgroundAs weight gain is one of the most frequently cited reasons for not using and for discontinuing hormonal contraceptives, in an open-label, single-arm, multicentre clinical study we evaluated the effect of the ethinylestradiol/norelgestromin contraceptive patch (EVRA, Janssen-Cilag International, Belgium) on body composition using bioelectrical impedance analysis (BIA).MethodsBody weight and impedance vector components (resistance (R) and reactance (Xc), at 50 kHz frequency, Akern-RJL Systems analyzer) were recorded before entry, after 1, 3 and 6 months in 182 Italian healthy women aged 29 yr (18 to 45), and with BMI 21.8 kg/m2 (16 to 31). Total body water (TBW) was estimated with a BIA regression equation. Vector BIA was performed with the RXc mean graph method and the Hotelling's T2 test for paired and unpaired data.ResultsAfter 6 months body weight increased by 0.64 kg (1.1%) and TBW increased by 0.51 L (1.7%). The pattern of impedance vector displacement indicated a small increase in soft tissue hydration (interstitial gel fluid). Body composition changes did not significantly differ among groups of previous contraceptive methods. Arterial blood pressure did not significantly change over time.ConclusionAfter 6 months of treatment with the ethinylestradiol/norelgestromin contraceptive patch we found a minimal, clinically not relevant, increase in body weight less than 1 kg that could be attributed to an adaptive interstitial gel hydration. This fluctuation is physiological as confirmed by the lack of any effect on blood pressure. This could be useful in increasing women's choice, acceptability and compliance of the ethinylestradiol/norelgestromin contraceptive patch.
Highlights
As weight gain is one of the most frequently cited reasons for not using and for discontinuing hormonal contraceptives, in an open-label, single-arm, multicentre clinical study we evaluated the effect of the ethinylestradiol/norelgestromin contraceptive patch (EVRA, JanssenCilag International, Belgium) on body composition using bioelectrical impedance analysis (BIA)
The impedance vector Z is a combination of resistance (R) and reactance (Xc)
The aim of the study was to test whether a 6-month treatment with the ethinylestradiol/norelgestromin contraceptive patch induced changes in body composition, in body fluid volume
Summary
As weight gain is one of the most frequently cited reasons for not using and for discontinuing hormonal contraceptives, in an open-label, single-arm, multicentre clinical study we evaluated the effect of the ethinylestradiol/norelgestromin contraceptive patch (EVRA, JanssenCilag International, Belgium) on body composition using bioelectrical impedance analysis (BIA). A large open-label, single-arm, multicentre clinical study (Phase IIIB/IV, NRGEEP-CON-402 "EVRA Contrast") has been carried out in Europe to evaluate women's experience with the ethinylestradiol/norelgestromin contraceptive patch, user satisfaction and user preference for the patch compared with their previous method of contraception. BIA is a non invasive method specific for assessment of soft tissue hydration based on the effect of the current flow through intra- and extracellular ionic solutions. An advantage of the vector approach is the lack of reliance on regression models to predict TBW and the inherent error associated with the use of group models to predict individual TBW [4,5]
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