Veru Completes Enrollment for Zuclomiphene Citrate Trial for ADT-Induced Hot Flashes in PC

Veru Completes Enrollment for Zuclomiphene Citrate Trial for ADT-Induced Hot Flashes in PC
Veru Healthcare has completed patient enrollment for its Phase 2 clinical trial evaluating the use of zuclomiphene citrate (VERU-944) for the treatment of hot flashes in men receiving hormone therapy for prostate cancer. Hot flashes are experienced by about 80% of men on androgen deprivation therapy (ADT). ADT works by lowering testosterone levels, but this also results in low estrogen — because estrogen in men is derived from testosterone — resulting in the inability to regulate temperature in the body. The main symptom of hot flashes is the subjective sensation of a rise in temperature in the face and trunk. This is accompanied by a dilation of blood vessels in the skin, mainly in the face, throat, and extremities, often followed by sweating. Hot flashes often persist throughout the course of androgen deprivation therapy, with a constant frequency and intensity. Zuclomiphene citrate is an oral nonsteroidal estrogen receptor agonist that increases the levels of estrogen. It has never been approved for any indication, but evidence from 39 studies of 2,200 men suggest it is well-tolerated for up to three years of use. The ongoing, randomized, Phase 2 clinical trial (NCT03646162) is studying whether zuclomiphene citrate is better than a placebo at controlling hot flashes in men with advanced prostate canc
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