Cardiovascular, Breast Safety Study of LibiGel In Women with Hypoactive Sexual Desire Disorder

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Michael C. Snabes, MD, PhD, vice president of clinical development of BioSante Pharmaceuticals (NASDAQ: BPAX), will be presenting an overview of a key study in the LibiGel® (testosterone gel) development program at The Endocrine Society’s 90th Annual Meeting in San Francisco at the Moscone Center on Sunday, June 15, 2008. The poster titled, “A Cardiovascular And Breast Safety Study Of Libigel® In Women with Hypoactive Sexual Desire Disorder (HSDD): Study Design And Description Of Endpoints,” is co-authored by investigators and consultants at the University of Connecticut School of Medicine, Berry Consultants, and the M.D. Anderson Cancer Center.

A news conference will be held on Sunday, June 15, 2008, at 8:30 AM PDT, during which reporters are invited to view the poster and discuss LibiGel and the described study with Dr. Snabes.

BioSante is conducting the safety study, in post-menopausal women with hypoactive sexual desire disorder (HSDD), at the request of the U.S. Food and Drug Administration. The FDA’s request is in line with the call for more safety data from The Endocrine Society, a medical specialty society that focuses on endocrine and metabolic diseases. 

Dr. Snabes noted the significance of this precedent-setting study, “This seminal clinical study, to examine the long-term effects of testosterone in post-menopausal women, may be one of the first large, cardiovascular event-driven, pre-approval studies undertaken in the absence of clear safety signals.”

BioSante expects to enroll and test approximately 3,000 post-menopausal women between the ages of 50 and 80 and who have at least one cardiovascular risk factor. The primary safety outcome for this trial is the effect of treatment on the incidence of cardiovascular events, including cardiovascular-related death, heart attack, and stroke. The incidence of invasive breast cancer is a co-primary safety endpoint, and investigators also will look for benign breast masses and non-invasive breast cancers. Patients will be assessed for hirsutism, acne, and voice or skin reactions, as well as blood testosterone levels during each study visit. Study results that bear out previous safety findings finally should lay to rest safety concerns regarding testosterone treatment in women, and lead to the approval of the first safe, effective treatment specifically indicated for HSDD in menopausal women.

HSDD is characterized by low libido and a general lack of interest in sex. If safety and efficacy endpoints are met and the FDA approves the drug, LibiGel will become the first FDA-approved treatment specifically indicated for HSDD in menopausal women. BioSante anticipates FDA approval some time during 2010 or 2011.

Female sexual dysfunction (FSD) can arise from many causes, including relationship problems, the use of prescription pharmaceuticals, disease, or chemical imbalances. HSDD, the biggest component of FSD, has been treated successfully and safely with testosterone for many years, albeit to date not approved for that use. In a completed Phase II study, LibiGel showed excellent safety and efficacy. However, FDA recently has become concerned with the cardiovascular and cancer risks associated with broad classes of drugs, among them potential therapies for FSD. The Phase III safety study is designed to confirm LibiGel’s long-term safety.

The placebo-controlled study will examine the effect of LibiGel in post-menopausal women at a dose of 300 micrograms per day over twelve months. BioSante specifically will focus on cardiovascular events and the incidence of breast cancer. After 12 months BioSante plans to apply for FDA approval through a New Drug Application (NDA). FDA requires BioSante to follow the study group for an additional 48 months, after NDA submission and potential approval, to compare the occurrence of cardiac events and breast cancer between the treatment group and a matched group of women who receive a placebo gel.

LibiGel® is a 1% testosterone gel that women apply, once a day, to their upper arm. The pea-sized volume of gel is rapidly absorbed by the skin, from where it delivers a steady dose of testosterone to the blood over 24 hours. In a Phase II clinical trial, LibiGel® increased the number of satisfying sexual events by 238%.

Although testosterone is thought of as a male hormone, it also is found in women at levels that vary with their age. Researchers believe that testosterone levels, which fall with increasing age, may control a woman’s sexual desire. For example, a woman in her 40’s has about half the level of blood testosterone than a woman in her 20’s.

The incidence of HSDD also increases with age and after certain surgical procedures. Approximately 14% of premenopausal women between the ages of 20 and 49 reported symptoms of HSDD, compared with 26% of women who had had their ovaries surgically removed. Similarly, the incidence of HSDD rises to 9% for “naturally” menopausal women. LibiGel® is designed to restore testosterone levels in post-menopausal women to levels that are considered normal to maintain a healthy libido.

Source: BioSante Pharmaceuticals

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