Phase I, two-way, crossover study to demonstrate bioequivalence and to compare safety and tolerability of single-dose XM17 vs Gonal-f(®) in healthy women after follicle-stimulating hormone downregulation.

CONCLUSIONS: PK bioequivalence of single 300-IU sc doses of XM17 to the reference product Gonal-f(®) was statistically demonstrated. XM17 was well tolerated both systemically and locally. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02592031 ; date of registration: 28 October, 2015. PMID: 26621118 [PubMed - in process]

http://www.ncbi.nlm.nih.gov/pubmed/26621118?dopt=Abstract

Source: Reproductive Biology - December 4, 2015 Category: Reproduction Medicine Authors: Lammerich A, Mueller A, Bias P Tags: Reprod Biol Endocrinol Source Type: research