Testosterone Spray Improves Sexual Desire in Women With Low Libido

VIVUS has announced that clinical data from a Phase II study showed treatment with the company's Testosterone MDTS, an investigational transdermal testosterone spray, significantly increased the number of satisfactory sexual events in premenopausal women with hypoactive sexual desire disorder (HSDD).

The 28-week, double-blind, randomized, placebo-controlled, dose-ranging study consisted of 261 premenopausal women with low serum testosterone and low libido that caused distress.

Patients were randomized to receive a once-daily administration of Testosterone MDTS or placebo spray to the abdomen over a 16-week treatment period. The primary endpoint of the study was the number of satisfactory sexual events reported by women over a four-week period at Week 16. The study was conducted at six sites across Australia by Acrux, under an investigational new drug application on file with the FDA.