Background: XM17 is a recombinant human follicle-stimulating hormone (rhFSH) intended mainly for use in\ncontrolled ovarian hyperstimulation and the treatment of anovulation. The purpose of the current study was to\nestablish bioequivalence, safety and tolerability of single 300-IU subcutaneous (sc) doses of XM17 to that of the\nreference follitropin alfa (Gonal-fÃ?®) in healthy young women.\nMethods: This open-label, Phase I, single-dose, single-center, two-way crossover study was conducted from\nFebruary to May 2009. Thirty-six women aged 18ââ?¬â??39 years were included, with a study duration of ~27 days\nper participant. After endogenous FSH downregulation with goserelin (3.6 mg) on study Day 0, XM17 and\nGonal-fÃ?® were administered on Days 11 and 19 in random sequence. Frequent serum samples were drawn for\nstandard pharmacokinetics until 168 h postdosing. Laboratory values, adverse events (AEs) and local tolerability\nwere assessed throughout the study period. Primary endpoints included Cmax and AUC0-t. Secondary endpoints\nincluded additional pharmacokinetic (PK) parameters, safety and tolerability.\nResults: Ratios of XM17 to Gonal-fÃ?® for Cmax and AUC0-t equaled 1.017 (90 % confidence interval [CI]: 0.958, 1.080)\nand 1.028 (90 % CI: 0.931, 1.134), respectively, with the CIs contained within the predefined interval (0.8, 1.25).\nRatios for AUC0-168h, AUC0-âË?ž and t1/2 were also ~1, and no difference in tmax was detected. Both XM17 and\nGonal-fÃ?® were well tolerated, with no detectable anti-FSH antibodies, serious AEs or AEs leading to discontinuation or\ndose reduction.\nConclusions: PK bioequivalence of single 300-IU sc doses of XM17 to the reference product Gonal-fÃ?® was statistically\ndemonstrated. XM17 was well tolerated both systemically and locally.
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