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These trials (which led to the approval of finasteride by the US Food and Drug Administration for the treatment of BPH in 1992) demonstrated that 5AR inhibition resulted in reduction in baseline prostate volume, improvement of urinary flow rate, and reduction in symptoms compared with placebo in patients with BPH.
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Finasteride pills are a medication that is taken to prevent conversion of testosterone to dihydrotestosterone (DHT) present in the body.
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In an embryo-fetal development study, pregnant rats received Finasteride during the period of major organogenesis (gestation days 6 to 17).
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Men with BPH who continue to experience significant lower urinary tract symptoms (LUTS, urgency, nocturia, hesitancy, and weak stream) or overactive bladder (OAB) while taking an AAB may benefit from the addition of an antimuscarinic agent.
Prostatic volume decreased significantly within three months in both finasteride-treated groups.
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The data from these studies, showing improvement in BPH-related symptoms, reduction in treatment failure (BPH-related urological events), increased maximum urinary flow rates, and decreasing prostate volume, suggest that PROSCAR arrests the disease process of BPH in men with an enlarged prostate.
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Finasteride Tablets USP, 5 mg will help reduce the risk of developing a sudden inability to pass urine and the need for surgery related to an enlarged prostate.
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This was reconfirmed in 1998 with a follow-up case series, in which results were extended to a mean follow-up of 3 years, demonstrating decrease in hematuria grade over this time period during finasteride therapy.
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During the 4- to 6-year placebo- and comparator-controlled Medical Therapy of Prostatic Symptoms (MTOPS) study that enrolled 3047 men, there were 4 cases of breast cancer in men treated with Finasteride tablets USP, 5 mg but no cases in men not treated with Finasteride tablets USP, 5 mg.
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