BioSante reports positive results from Phase II study of oral contraceptive

The Pill-Plus adds a third hormone, an androgen, to the normal two hormone (estrogen and progestogen) oral contraceptive to prevent androgen deficiency which often leads to a decrease in sexual desire, sexual activity and mood changes.

In a completed Phase II double-blind randomized clinical trial, the addition of an oral androgen resulted in restoration of testosterone levels to the normal and physiological range for healthy women. The Pill-Plus is said to be designed to improve the condition known as female sexual dysfunction in oral contraceptive users, among other potential benefits.

In addition to this completed study, Pantarhei is engaged in several other Phase II/III clinical studies of the Pill-Plus. The objectives of the other studies are many, including investigating the effect of oral androgen on the pharmacokinetics of oral contraceptives and the effects of adding an androgen to oral contraceptive treatment on sexual function and other measures.

The Pill-Plus for oral use is licensed to Pantarhei Bioscience, a Netherlands-based pharmaceutical company for development and marketing in the US. BioSante retains rights to the Pill-Plus for transdermal development and marketing.

Stephen Simes, president and CEO of BioSante, said: “We are pleased with the results to date in the clinical work being carried-out by Pantarhei. We look forward to additional clinical results in the Pill-Plus’s development program in 2009.”