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Estrogens with or without progestins should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.

Estrogen treatment of prepubertal children also induces premature breast development and vaginal cornificationand may potentially induce vaginal bleeding in girlsIn boysestrogen treatment may modify the normal pubertal processAll other physiological and adverse reactions shown to be associated with estrogen treatment of adults could potentially occur in the pediatric populationincluding thromboembolic disorders and growth stimulation of certain tumorsThereforeestrogens should only be administered to pediatric patients when clearly indicated and the lowest effective dose should always be utilized.

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Clinical surveillance of all women taking estrogen/progestin combinations is importantsee PRECAUTIONSAdequate diagnostic measuresincluding endometrial sampling when indicatedshould be undertaken to rule out malignancy in all cases of undiagnosed persistent or recurring abnormal vaginal bleedingThere is no evidence that the use of natural estrogens results in a different endometrial risk profile than synthetic estrogens of equivalent estrogen doseAdding a progestin to estrogen therapy has been shown to reduce the risk of endometrial hyperplasiawhich may be a precursor to endometrial cancer.

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