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Another patient may need an intermediate dose during a dose reduction phase

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The supplemental approval was granted based on data from the Phase III EMBARK trial, which studied Xtandi plus leuprolide, placebo plus leuprolide (a synthetic hormone regulator) and Xtandi as a monotherapy

PT-141 is FDA-approved for premenopausal women diagnosed with acquired, generalized hypoactive sexual desire disorder (HSDD)