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Topical testosterone replacement gel therapy safe, effective in hypogonadism
Men with hypogonadism using a topical testosterone replacement gel therapy administered with a hands-free cap applicator reported high satisfaction with the treatment and had improved testosterone levels, according to published data.
“The phase 3 study is aimed to support regulatory approval of this new testosterone replacement gel,” Anders Neijber, MD, PhD, of the International PharmaScience Center at Ferring Pharmaceuticals in Denmark, told Endocrine Today.
Neijber and colleagues conducted an open-label, noncomparator study on 159 men with hypogonadism to determine the safety and efficacy of testosterone gel 2% over 90 days. All participants applied 23 mg testosterone gel per day using a hands-free cap applicator. After 2 weeks, the dose could be increased to 46 mg per day if the 4-hour serum total testosterone level was less than 500 ng/dL and could be further increased or decreased to 23 mg, 46 mg and 69 mg on days 21, 42 and 63. Safety data was collected at a 30-day follow-up.
At baseline, most participants had secondary hypogonadism (96.2%). At day 90, 76.1% of participants had average serum total testosterone concentration within the target range of 300 ng/dL to 1,050 ng/dL.
Most participants reported they were “very satisfied” or “satisfied” using the hand-free cap applicator (93.5%); 87.7% reported it was “very easy” to use and 87% reported they felt less risk for transfer of testosterone to others through direct contact with the application site or hands.
Overall, 59 participants experienced 119 mild to moderate adverse events. Bronchitis, upper respiratory tract infection and cough were the most commonly reported adverse events. Five participants experienced a serious adverse event, including malignant lung neoplasm, upper limb fracture, unstable angina, myocardial infarction with stents placement and progression of degenerative osteoarthritis. Eight participants experienced a mild to moderate application site reaction.
“This is a phase 3 study with a novel transdermal 2% gel technology that provides high bioavailability and fast absorption of testosterone through the skin,” Neijber said. “This allows for a low testosterone gel volume and less active drug on the skin when applied with a convenient ‘hand-free’ cap applicator, limiting the risk of testosterone transference (eg, to the partner). The study results show similar efficacy and a favorable local tolerability to other [testosterone] gels. Further phase 3b and phase 4 studies may show placebo or active-controlled data in patients with hypogonadism.” – by Amber Cox
Disclosure: Neijber reports being an employee of Ferring Pharmaceuticals.