{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,12,7]],"date-time":"2025-12-07T03:45:56Z","timestamp":1765079156253,"version":"build-2065373602"},"reference-count":20,"publisher":"Wiley","issue":"8","license":[{"start":{"date-parts":[[2012,1,6]],"date-time":"2012-01-06T00:00:00Z","timestamp":1325808000000},"content-version":"vor","delay-in-days":888,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["accpjournals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Pharmacotherapy"],"published-print":{"date-parts":[[2009,8]]},"abstract":"<jats:p><jats:bold>Study Objective.<\/jats:bold> To assess the potential for a drug\u2010drug interaction between a representative hormonal contraceptive (norgestimate\u2010ethinyl estradiol) and tenofovir disoproxil fumarate (tenofovir DF), a prodrug of tenofovir, when coadministered.<\/jats:p><jats:p><jats:bold>Design.<\/jats:bold> Thirty\u2010day, open\u2010label, fixed\u2010sequence, pharmacokinetic drug\u2010drug interaction study.<\/jats:p><jats:p><jats:bold>Setting.<\/jats:bold> Single clinical phase I center.<\/jats:p><jats:p><jats:bold>Participants.<\/jats:bold> Twenty nonpregnant and nonlactating women aged 19\u201345 years who were taking a norgestimate\u2010ethinyl estradiol oral contraceptive.<\/jats:p><jats:p><jats:bold>Intervention.<\/jats:bold> Each woman received norgestimate\u2010ethinyl estradiol alone on study days 1\u201322, followed by norgestimate\u2010ethinyl estradiol plus tenofovir DF 300 mg once\/day for 7 days during two consecutive 28\u2010day contraceptive cycles.<\/jats:p><jats:p><jats:bold>Measurements and Main Results.<\/jats:bold> Pharmacokinetic assessments were performed over 24 hours on study days 1 and 29 (corresponding to matching days [day 21] of the two contraceptive cycles). Serum or plasma concentrations of tenofovir, norgestimate and its active metabolite deacetyl norgestimate, and ethinyl estradiol were measured by high\u2010performance liquid chromatography\u2010tandem mass spectrometry assays. Geometric mean ratios (90% confidence intervals) for the pharmacokinetic parameters for deacetyl norgestimate and ethinyl estradiol were estimated by using analysis of variance and compared with the no\u2010effect criterion for bioequivalence. The tenofovir pharmacokinetic parameters were compared with historical controls. Pharmacokinetic parameters for deacetyl norgestimate and ethinyl estradiol were unaltered by coadministration of tenofovir DF. The tenofovir pharmacokinetic parameters in subjects receiving norgestimate\u2010ethinyl estradiol were consistent with historical control data for tenofovir.<\/jats:p><jats:p><jats:bold>Conclusion.<\/jats:bold> Tenofovir DF and norgestimate\u2010ethinyl estradiol are not involved in a clinically significant drug\u2010drug interaction; tenofovir DF did not affect the steady\u2010state pharmacokinetics of norgestimate or ethinyl estradiol, including the concentration at the end of the dosing interval. Both drugs were well tolerated when coadministered. Tenofovir DF is unlikely to affect the pharmacokinetics of hormonal oral contraceptives.<\/jats:p>","DOI":"10.1592\/phco.29.8.924","type":"journal-article","created":{"date-parts":[[2009,7,28]],"date-time":"2009-07-28T10:17:45Z","timestamp":1248776265000},"page":"924-929","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":42,"title":["Lack of Effect of Tenofovir Disoproxil Fumarate on Pharmacokinetics of Hormonal Contraceptives"],"prefix":"10.1002","volume":"29","author":[{"given":"Brian P.","family":"Kearney","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Anita","family":"Mathias","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2012,1,6]]},"reference":[{"key":"e_1_2_1_2_2","unstructured":"The Joint United Nations Programme on HIV\/AIDS (UNAIDS)\/World Health Organization.AIDS epidemic update: December 2007. 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