Testosterone nasal gel shows safety, efficacy

A new testosterone nasal gel (Natesto) is safe and efficacious, according to phase III data presented at the Endocrine Society annual meeting in San Diego.

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The phase III clinical trial evaluated the effectiveness and safety of the testosterone nasal gel in 306 men with low testosterone at 39 U.S. outpatient centers. Men used the treatment for 90 days in both nostrils either twice per day (228 men) or three times per day (78 men) as randomly assigned, to find the most effective dose. They then stayed on the drug for another 90 or 180 days to evaluate tolerance to the medication and effects of treatment.

After 90 days of treatment, the average testosterone concentration in the blood was in the normal range for 90% of men who used the nasal gel three times daily, compared with 71% of men using it twice per day. (This measure was in the intent-to-treat population: all subjects who received the randomized study drug and had at least one valid post-baseline efficacy measurement.)

The manufacturer’s recommended dosing is now three times per day in each nostril, for a total daily dose of 33 mg.

Treatment also strongly improved men’s erectile function and mood, reported lead investigator Alan Rogol, MD, PhD, of the University of Virginia, Charlottesville.

No serious medical problems related to the medicine occurred in either dosing group, according to the investigators. In addition, Dr. Rogol said there were low rates of problems with tolerating the nasal gel, with 3.7% of men receiving the three-times-daily dose discontinuing use of the medication because of side effects.

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Of 99 men who completed a survey on their experience with the drug, 84% felt confident they were correctly using the pump applicator within 2 days of beginning treatment.

“These results indicate that testosterone nasal gel is an effective and practical alternative to other available testosterone replacement therapy products,” Dr. Rogol said in an Endocrine Society news release.

Dr. Rogol is a consultant to Trimel Pharmaceuticals, which manufactures the gel.

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