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Scientific rationale and design of a phase I safet

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Scientific rationale and design of a phase I safet

Postby caryn » Sat May 09, 2009 10:53 pm

by caryn (10131 Posts), Sat May 09, 2009 10:53 pm

...Previous clinical studies have strongly suggested that relaxin is a systemic and renal vasodilator. In nonclinical studies, relaxin administration to monkeys has been associated with increased vessel density in the endometrium, and in previous human trials relaxin administration has been highly correlated with increased menstrual bleeding in women. VEGF has been proposed as a mechanism for these endometrial effects. Together, these data suggest that relaxin may be able to relieve systemic and renal vasoconstriction and improve placental perfusion in women with preeclampsia. As a first step in the development program for relaxin in this indication, a multicenter, randomized, double-blind, placebo-controlled phase I safety study in women with severe preeclampsia has been launched in the USA...

http://www.ncbi.nlm.nih.gov/pubmed/19416224

So this is the first trial, and it's to see if relaxin is safe to administer to pregnant women, but they're also going to check and see if it works at all, 'cause it seems like it ought to. :-)

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