{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"submitter":["Scarsi KK"],"funding":["National Institute of Allergy and Infectious Diseases","Eunice Kennedy Shriver National Institute of Child Health and Human Development","NCATS NIH HHS","NICHD NIH HHS","NIAID NIH HHS","National Institutes of Health"],"pagination":["109951"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC10187685"],"repository":["biostudies-literature"],"omics_type":["Unknown"],"volume":["121"],"pubmed_abstract":["<h4>Objectives</h4>To determine if double-dose levonorgestrel emergency contraception (EC) in combination with efavirenz or rifampicin, 2 drugs known to decrease levonorgestrel exposure, resulted in similar pharmacokinetics compared to standard-dose levonorgestrel EC without drug-drug interactions.<h4>Study design</h4>We conducted a phase 2, open-label, multicenter, partially randomized, 4 parallel group trial in pre-menopausal females ≥16 years old without an indication for EC and not on hormonal contraception. Participants on dolutegravir-based antiretroviral therapy (ART) received levonorgestrel 1.5 mg (control group); those on rifampicin-containing tuberculosis therapy received levonorgestrel 3 mg; those on efavirenz-based ART were randomized 1:2 to levonorgestrel 1.5 mg or 3 mg. Plasm"],"journal":["Contraception"],"pubmed_title":["Pharmacokinetics of dose-adjusted levonorgestrel emergency contraception combined with efavirenz-based antiretroviral therapy or rifampicin-containing tuberculosis regimens."],"pmcid":["PMC10187685"],"funding_grant_id":["UM1 AI069423","UM1 AI069521","UL1 TR001422","UM1 AI068634","UM1 AI068636","U01 AI068636","U01 AI069463","UM1 AI069463","UM1 AI106701","UM1 AI069456","UL1 TR002384","UL1 TR002489","U01 AI069471","UM1 AI069419","UM1 AI069518","R01 HD085887","UL1 TR001857","UM1 AI069494","U01 AI069476","U01 AI069399","UM1 AI069471","UM1 AI069432","UM1 AI069399","UM1 AI069476","UM1 AI069453"],"pubmed_authors":["Smeaton LM","Belaunzaran-Zamudio PF","Scarsi KK","Barr E","Jalil EM","Gadama L","Mngqibisa R","Badal-Faesen S","Godfrey C","Podany AT","Woolley E","Gatechompol S","Olefsky M","Cohn SE","AIDS Clinical Trials Group A5375 Study Team","Pham M","Supparatpinyo K","Mawlana S"],"additional_accession":[]},"is_claimable":false,"name":"Pharmacokinetics of dose-adjusted levonorgestrel emergency contraception combined with efavirenz-based antiretroviral therapy or rifampicin-containing tuberculosis regimens.","description":"<h4>Objectives</h4>To determine if double-dose levonorgestrel emergency contraception (EC) in combination with efavirenz or rifampicin, 2 drugs known to decrease levonorgestrel exposure, resulted in similar pharmacokinetics compared to standard-dose levonorgestrel EC without drug-drug interactions.<h4>Study design</h4>We conducted a phase 2, open-label, multicenter, partially randomized, 4 parallel group trial in pre-menopausal females ≥16 years old without an indication for EC and not on hormonal contraception. Participants on dolutegravir-based antiretroviral therapy (ART) received levonorgestrel 1.5 mg (control group); those on rifampicin-containing tuberculosis therapy received levonorgestrel 3 mg; those on efavirenz-based ART were randomized 1:2 to levonorgestrel 1.5 mg or 3 mg. Plasm","dates":{"release":"2023-01-01T00:00:00Z","publication":"2023 May","modification":"2026-05-29T01:22:15.181Z","creation":"2025-04-19T20:52:18.274Z"},"accession":"S-EPMC10187685","cross_references":{"pubmed":["36641094"],"doi":["10.1016/j.contraception.2023.109951"]}}