Repros Therapeutics Inc. announced it has completed enrollment for one of two clinical trials pitting its topical testosterone gel alternative Androxal against other topical testosterone products currently on the market.
Each trial will include 120 men, who will be divided into groups of 40 for three parallel study arms to test Androxal against an already marketed testosterone gel and a placebo. Studies will run for 17 weeks, which includes 16 weeks of dosing and one week of follow-up to gather information for the conclusion.
Repros sought men who were at least 60 years of age who exhibited a normal sperm count range at baseline on two days of separate testing. The participants also had to exhibit morning testosterone of less than 300 ng/dL on both of these testing days in order to qualify for the trial.
The trials aim to determine whether patients using Androxal achieve both a normal testosterone level and normal sperm concentration compared to patients given a placebo and patients given an already approved testosterone gel.
“These endpoints will provide a comparison of Androxal to the topical gel from the perspective of normalizing testicular function,” the company said.
Researchers will also continue to measure efficacy and safety during the trials. “Safety assessments will include impact on hematocrit, an important cardiovascular safety marker,” the company said.
Prescriptions for testosterone therapy have dramatically increased in the past decade in response to heavy marketing campaigns from drug companies pushing the products as a treatment for symptoms of “Low T,” which include a low sex drive, weight gain, and muscle loss.
Recent studies have raised red flags about supplemental testosterone treatments, such as topical gels AndroGel and Testim. The drugs have been associated with an increased risk of heart attack, stroke and death from any cause. The Food and Drug Administration (FDA) recently announced it had launched an investigation into health risks associated with the drugs.
Source: Bio News