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 cancer. It has enrolled 95 patients at 24 clinical sites across the U.S. All participants experienced moderate-to-severe hot flashes while on ADT. The researchers note that moderate hot flashes are defined as a sensation of heat with sweating that allow men to continue their activity, while severe hot flashes cause men to cease activity until the hot flash decreases in intensity.
Participants were random selected to receive oral zuclomiphene citrate in 10 mg or 50 mg doses or a placebo every day for 12 weeks.
The study’s primary goal is to assess how the frequency of moderate-to-severe hot flashes changes after the 12-week period. Secondary measures include a reduction in the the severity of hot flashes and improvements in bone markers. Top-line results are expected in the next few months.
“Hot flashes induced by ADT can be so severe as to cause delay or early discontinuation of ADT,” Mitchell Steiner, MD, chairman, president and CEO of Veru, said in a press release. “Our proprietary zuclomiphene citrate product has the potential to be the first FDA-approved treatment for this most common and debilitating side effect of ADT as hot flashes occur in up to 80% of men.”
“We are very pleased to have achieved this important enrollment milestone. We look forward to seeing the topline efficacy results and safety data from this Phase 2 trial in the Fall of 2019,” Steiner added. “We remain on track for initiation of the Phase 3 clinical study in early 2020.”