BioSante Pharmaceuticals, Inc. (NASDAQ:BPAX) announced today positive results in a Phase II study of the Pill-Plus "triple hormone" oral contraceptive (OC). Results showed an increase in the frequency of sexual activity (p< 0.05) and reduced frequency of rejection of initiation of sexual activity by partner (p< 0.05).
“We are pleased with the results to date in the clinical work being carried-out by Pantarhei Bioscience, our Pill-Plus licensee”
The study was a Phase II double-blind randomized clinical trial in 82 women comprising a cross-over design of two treatment periods of five months each. The study compared use of an OC alone to the same OC with the addition of an oral androgen (DHEA). The study was performed by Dr. Rik van Lunsen and Dr. Ellen Laan from the Department of Sexology of the Academic Medical Center in Amsterdam, The Netherlands in close collaboration with the Professor Herjan Coelingh Bennink and Dr. Yvette Zimmerman from Pantarhei Bioscience in The Netherlands. First results were reported on May 20, 2010 at the 11th Congress of the European Society of Contraception in The Hague, The Netherlands. Additional data will be reported upon full publication of the results of the study.
Paradoxically, many women who use OCs have reduced sexual desire, arousabilty and sexual activity due to the effects of estrogen and progestogen in normal OCs. The Pill-Plus is designed to restore testosterone levels that are significantly suppressed during OC use as documented in this Phase II study. A condition known as female sexual dysfunction (FSD) in oral contraceptive users, among other potential benefits, could be improved by adding an androgen, e.g., DHEA or testosterone to the OC regimen.
"We are pleased with the results to date in the clinical work being carried-out by Pantarhei Bioscience, our Pill-Plus licensee," said Stephen M. Simes, BioSante's president & CEO. "We look forward to additional clinical results in the Pill-Plus' development program in the next 12 months. These efforts by Pantarhei in women taking OCs, in addition to our Phase III LibiGel clinical program in the treatment of FSD in menopausal women, highlight BioSante as a leader in women's sexual health in the United States."
The Pill-Plus United States patents for oral use are licensed by BioSante to Pantarhei Bioscience, a Netherlands-based pharmaceutical company, for development and marketing in the United States. BioSante retains rights to the Pill-Plus for transdermal development and marketing.
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 restoration of testosterone levels by oral DHEA on the pharmacokinetics of oral contraceptives and the effects of adding DHEA to oral contraceptive treatment on sexual function and other measures including mood, muscle mass and fat and bone parameters.
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