Effect of the ethinylestradiol/norelgestromin contraceptive patch on body composition. Results of bioelectrical impedance analysis in a population of Italian women.

Background: 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, Janssen-Cilag Interna...

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Publicado en:Nutrition Journal Vol. 7; pp. 21 - 22
Autores principales: Piccoli A, Crosignani P, Nappi C, Ronsini S, Bruni V, Marelli S, Piccoli, Antonio, Crosignani, PierGiorgio, Nappi, Carmine, Ronsini, Salvatore, Bruni, Vincenzina, Marelli, Silvia
Formato: clinical trial research Journal Article
Publicado: BioMed Central 2008
Acceso en línea:Ver este registro en EBSCOhost
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      dt: 2008
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      pub: BioMed Central
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        atl: Effect of the ethinylestradiol/norelgestromin contraceptive patch on body composition. Results of bioelectrical impedance analysis in a population of Italian women.
      aug:
        au:
          Piccoli A
          Crosignani P
          Nappi C
          Ronsini S
          Bruni V
          Marelli S
          Piccoli, Antonio
          Crosignani, PierGiorgio
          Nappi, Carmine
          Ronsini, Salvatore
          Bruni, Vincenzina
          Marelli, Silvia
        affil: Department of Medical and Surgical Sciences, University of Padova, Italy
      sug:
        subj:
          Body Composition Drug Effects
          Contraceptives, Oral Combined Administration and Dosage
          Contraceptives, Oral Combined Adverse Effects
          Weight Gain Drug Effects
          Administration, Transcutaneous
          Adolescence
          Adult
          Amines Administration and Dosage
          Amines Adverse Effects
          Body Mass Index
          Body Water Drug Effects
          Body Water Metabolism
          Clinical Trials
          Electric Impedance
          Female
          Middle Age
          Progestational Hormones, Synthetic Administration and Dosage
          Progestational Hormones, Synthetic Adverse Effects
          Progestational Hormones, Synthetic Analogs and Derivatives
          Steroids Administration and Dosage
          Steroids Adverse Effects
          Weight Gain Physiology
          Human
          Adolescent: 13-18 years
          Adult: 19-44 years
          Middle Aged: 45-64 years
          Female
      ab: Background: 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, Janssen-Cilag International, Belgium) on body composition using bioelectrical impedance analysis (BIA).Methods: Body 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.Results: After 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.Conclusion: After 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.
      pubtype: Academic Journal
      doctype:
        clinical trial
        research
        Journal Article
      ougenre: Article
    language: English
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