Register for Phase II trial for LibiGel completed
Female Sexual DysfunctionJuly 19, 2004
2004 JUL 19 - (NewsRx.com & NewsRx.net) -- BioSante Pharmaceuticals, Inc., (BPA) announced that it has completed its phase II clinical trial of LibiGel (transdermal testosterone gel) for the treatment of female sexual dysfunction (FSD).
The trial was a double-blind, placebo-controlled study, conducted in the United States, that included 46 patients to determine the effect of LibiGel on women's sexual desire and activity. The primary data (frequency of satisfying sexual events) from the phase II trial currently are being analyzed.
The safety profile for subjects receiving LibiGel was similar to that observed for subjects in the placebo group. There were no serious adverse events and no discontinuations due to adverse events in any subject receiving LibiGel, indicating the safety and acceptability of LibiGel.
"We concluded the LibiGel phase II trial earlier than anticipated based on a previous interim analysis, and on data recently announced by Procter & Gamble on a phase III clinical trial of their testosterone patch for FSD," said Leah M. Lehman, vice president of clinical and regulatory affairs for BioSante.
"The P&G study data indicate that the testosterone patch resulted in a statistically significant increase in sexual activity in women. Based on the interim analysis we are confident that LibiGel will have similar effects and expect the final data from our phase II clinical trial will allow us to move into phase III," Lehman said.
BioSante announced late last year that a blinded interim analysis of the then ongoing phase II trial of LibiGel showed statistically significant results for the primary endpoint of the study.
The interim study data, presented at a meeting of the International Society for the Study of Women's Sexual Health (ISSWSH) in Amsterdam, showed that after 3 months of treatment there was a 130% increase in the frequency of satisfying sexual events as measured by individual patient diaries.
The interim analysis reported on the first 28 patients who had completed the study without breaking the blind as to dose of LibiGel or placebo. The data indicated an effective LibiGel dose for the treatment of hypoactive sexual desire disorder (HSDD) in women, and that LibiGel was well tolerated during the course of the trial. BioSante had previously completed three phase I/II LibiGel clinical trials to determine blood levels of testosterone delivered by six different doses of LibiGel.
"Clinical data indicate that LibiGel improves sexual activity and desire in women suffering from HSDD and we believe that LibiGel can make an important contribution to the well-being of women," said Stephen M. Simes, president and chief executive officer of BioSante.
"Female sexual dysfunction is underserved by the pharmaceutical industry today; in fact, there is no pharmaceutical product on the market for the treatment of FSD. We are very pleased LibiGel, which offers important advantages in patient acceptance, may help successfully address this unmet medical need," Simes said.
LibiGel is a gel formulation of bioidentical testosterone designed to be quickly absorbed through the skin after application on the arms, shoulders or abdomen, delivering testosterone to the bloodstream evenly over time and in a non-invasive and painless manner.
Though generally characterized as a male hormone, testosterone also is present in women and its deficiency has been found to decrease libido or sex drive. Studies have further shown that testosterone therapy can increase bone density, raise energy levels and improve mood, in addition to boosting sexual desire and pleasure.
According to a study published in the Journal of the American Medical Association, 43% of American women (about 40 million) experience some degree of impaired sexual function.
Among the more than 1400 women surveyed, 32% lacked interest in sex and 26% could not experience orgasm. The majority of women with FSD are postmenopausal, experiencing FSD due to hormonal changes following menopause, whether natural or surgical. This article was prepared by Biotech Business Week editors from staff and other reports. Copyright 2004, Biotech Business Week via NewsRx.com & NewsRx.net.
©Copyright 2004, Women's Health Weekly via NewsRx.com & NewsRx.net
