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67th Annual Meeting Abstracts
Toremifene 80 mg Demonstrates a Reduction in Hot Flashes in Phase III Trial Compared to Placebo in Men on ADT
Paul Sieber1, Michael Rommel1, *Ronald Morton2
1Urological Associates of Lancaster, Ltd, Lancaster, PA;2GTx, Inc, Memphis, TN
Introduction: :
ADT results in castrate levels of testosterone leading to estrogen deficiency side effects such as hot flashes. In a randomized, double-blind, placebo controlled trial to determine if toremifene 80 mg prevents fractures in men on ADT, we assessed the effect of toremifene on hot flashes.
Materials & Methods:
1389 men with prostate cancer were randomized to toremifene or placebo for up to 24 months. Hot flashes were reported using a 7−day diary at baseline and every 3 months. Severe hot flashes and flushing were recorded as AEs and analyzed between treatment groups based on the ITT population.
Results:
US subjects with ≥ 6 hot flashes/day, not on Megace®, were analyzed (toremifene=18 subjects, placebo=19 subjects). Toremifene reduced the incidence of hot flashes from baseline at 6 months by 42% (26% decrease placebo) with a trend in favor of toremifene (p=0.0597). At 9 months, toremifene significantly reduced the incidence of hot flashes from baseline by 42% compared to an 18% decrease in placebo (p=0.0457). The effect was maintained for the duration of the study. The incidence of severe hot flashes and flushing reported as AEs was lower in the toremifene group (3.9%) compared to placebo (5.8%), showing a statistical trend in favor of toremifene (p=0.1188).
Conclusions:
Toremifene 80 mg demonstrated the ability to reduce hot flashes in a subset population that experienced on average a higher number of hot flashes at baseline than that observed in the ITT population. Additionally, fewer subjects reported severe hot flashes and flushing as AEs.
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