{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,4]],"date-time":"2026-10-04T04:36:09Z","timestamp":1791088569465,"version":"4.1.0"},"reference-count":29,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2009,2,25]],"date-time":"2009-02-25T00:00:00Z","timestamp":1235520000000},"content-version":"vor","delay-in-days":24,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Birth Defects Research Pt B"],"published-print":{"date-parts":[[2009,2]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p><jats:bold>BACKGROUND<\/jats:bold>: The covalent modification of interferon (IFN) \u03b12b with monomethyoxy polyethylene glycol (PEG) reduces its clearance rate and increases its half\u2010life. High doses of interferon (IFN) \u03b12b have previously been shown to affect maintenance of pregnancy in rhesus monkeys. Given the role of ovarian hormones in reproductive function and pregnancy, this study was conducted to assess the effects of PEG\u2010IFN\u03b12b or IFN\u03b12b (comparative control) on ovarian hormones and menstrual cyclicity in cynomolgus monkeys. In addition, the potential for reversibility of PEG\u2010IFN\u03b12b or IFN\u03b12b\u2010related observations was assessed. <jats:bold>METHODS<\/jats:bold>: Monkeys were administered 3,105\u2009\u00b5g\/m<jats:sup>2<\/jats:sup> human recombinant (hr) IFN\u03b12b or 52, 262, or 4,239\u2009\u00b5g\/m<jats:sup>2<\/jats:sup> PEG\u2010hr\u2010IFN\u03b12b every other day for one menstrual cycle, followed by a post\u2010dose period of up to two menstrual cycles. <jats:bold>RESULTS<\/jats:bold>: Monkeys administered 3,105\u2009\u00b5g\/m<jats:sup>2<\/jats:sup>\u2009hr\u2010IFN\u03b12b or 52, 262, or 4,239\u2009\u00b5g\/m<jats:sup>2<\/jats:sup> PEG\u2010hr\u2010IFN\u03b12b exhibited transient decreases in food consumption, leukocyte and erythrocyte parameters. Monkeys administered 3,105\u2009\u00b5g\/m<jats:sup>2<\/jats:sup>\u2009hr\u2010IFN\u03b12b exhibited lengthened menstrual cycles that were associated with a delay in reaching peak ovarian hormone levels and lower respective peak concentrations. Similarly, monkeys administered 4,239\u2009\u00b5g\/m<jats:sup>2<\/jats:sup> PEG\u2010hr\u2010IFN\u03b12b exhibited lengthened menstrual cycles and a delay in reaching peak ovarian hormone levels and slightly lower respective peak concentrations. Post\u2010dosing menstrual cycle length, estradiol and progesterone profiles exhibited evidence of recovery in both the hr\u2010IFN\u03b12b and the high\u2010dose PEG\u2010hr\u2010IFN\u03b12b groups. <jats:bold>CONCLUSIONS<\/jats:bold>: Administration of hr\u2010IFN\u03b12b or PEG\u2010hr\u2010IFN\u03b12b at high doses to cynomolgus monkeys resulted in similar effects on menstrual cycles, estradiol and progesterone profiles, and exhibited evidence of reversibility upon cessation of dosing. These results suggest that the previously observed high\u2010dose IFN\u03b1\u2010related effects on the maintenance of pregnancy in monkeys are likely the result of altered ovarian function. <jats:italic>Birth Defects Res (Part B)<\/jats:italic> 86:29\u201039, 2009. \u00a9 2009 Wiley\u2010Liss, Inc.<\/jats:p>","DOI":"10.1002\/bdrb.20179","type":"journal-article","created":{"date-parts":[[2009,2,25]],"date-time":"2009-02-25T20:18:00Z","timestamp":1235593080000},"page":"29-39","source":"Crossref","is-referenced-by-count":10,"title":["Comparative effects of interferon alpha\u20102b and pegylated interferon alpha\u20102b on menstrual cycles and ovarian hormones in cynomolgus monkeys"],"prefix":"10.1002","volume":"86","author":[{"given":"Brian P.","family":"Enright","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David R.","family":"Compton","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nathaniel","family":"Collins","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thomas","family":"Davis","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Barry S.","family":"McIntyre","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2009,2,25]]},"reference":[{"key":"e_1_2_6_2_1","unstructured":"Animal Welfare Act. 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