Pharmacokinetics of Oral Levonorgestrel in Women After Roux-en-Y Gastric Bypass Surgery and in BMI-Matched Controls
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ORIGINAL CONTRIBUTIONS
Pharmacokinetics of Oral Levonorgestrel in Women After Roux-en-Y Gastric Bypass Surgery and in BMI-Matched Controls Charlotte Ginstman 1,2 & Helena Kopp Kallner 3,4 & Johanna Fagerberg-Silwer 5 & Björn Carlsson 6,7 & Andreas Ärlemalm 6,7 & Ylva Böttiger 7,8 & Jan Brynhildsen 1,2
# The Author(s) 2020
Abstract Background Women are advised to primarily use non-oral contraceptive alternatives after Roux-en-Y gastric bypass since it is not known if the surgery affects the pharmacokinetics of oral contraceptives. Methods This is a multi-center, open label, phase 2 pharmacokinetic study performed at the University Hospital of Linköping and the Clinical Trials Center, Department of Obstetrics and Gynecology, Danderyd Hospital, Karolinska Institutet, Stockholm, Sweden. Fifteen women aged 18–40 years who had previously undergone Roux-en-Y gastric bypass surgery and reached a BMI < 30 were included. Fifteen BMI-matched women with no previous history of Roux-en-Y gastric bypass surgery served as a control group. After administration of a single dose of a combined oral contraceptive containing 0.03 mg ethinylestradiol/0.15 mg levonorgestrel, serum levonorgestrel concentrations were determined during a 24-h period using ultra performance liquid chromatography/tandem mass spectrometry. The area under the plasma concentration time curve of levonorgestrel (AUC0–24h) was the main outcome measure. Results There were no significant differences in the studied pharmacokinetic parameters, AUC0–24h, total AUC, peak serum concentration (Cmax), time to peak serum concentrations (Tmax), apparent oral clearances of levonorgestrel (CLoral), or terminal half-lives (t½) between the groups. Conclusion This is to our knowledge the first study to evaluate the pharmacokinetics of oral levonorgestrel in women with a BMI < 30 at least 1 year after RYGB compared with a BMI-matched group of women. We could not find any significant pharmacokinetic differences between the groups, suggesting that oral levonorgestrel may be used in non-obese women after Roux-en-Y gastric bypass once a stable body weight has been reached. Clinical Trial Number EudraCT 2014–004677-17. Keywords Gastric bypass surgery . Levonorgestrel . Obesity . Oral contraceptives . Pharmacokinetics
Introduction It is recommended that women avoid pregnancy for at least 12 months after bariatric surgery [1, 2]. This is to promote * Charlotte Ginstman [email protected] 1
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Department of Obstetrics and Gynecology, Linköping University, University Hospital, 58185 Linköping, Sweden Department of Clinical and Experimental Medicine, Linköping University, University Hospital, 58185 Linköping, Sweden Department of Obstetrics and Gynecology, Karolinska Institutet, 17177 Stockholm, Sweden
optimal postoperative weight loss and to avoid a potential risk of small-for-gestational-age infants and intrauterine growth restriction after bariatric surgery [3]. During recent years, there has been a change in bariatric surgery methods. Today, sleeve 4
Department of Women’s
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