Study is key for approval of first drug for female sexual dysfunction

June 15, 2008

Women are being recruited to participate in a new multicenter study of the safety of testosterone gel for postmenopausal women with low sexual desire. The study design and goals will be presented at The Endocrine Society's 90th Annual Meeting in San Francisco.

The testosterone gel, LibiGel®, has the "potential to be the first drug approved to treat female sexual dysfunction in menopausal women," said Michael Snabes, MD, PhD, medical director for BioSante Pharmaceuticals, Inc. BioSante makes LibiGel and is funding the research.

"Despite several currently approved pharmaceutical products for men with sexual dysfunction, no drug has been approved in the U.S. for female sexual dysfunction," he said.

The company seeks to enroll 2,400 to 3,100 women ages 50 to 80 who have hypoactive sexual desire disorder (HSDD). This condition is the most common type of female sexual dysfunction, affecting 14 to 39 percent of women. HSDD is the persistent or recurrent absence of sexual fantasies, thoughts and desires, causing the woman distress and resulting in lower sexual activity. After menopause, a woman's body produces less testosterone, which may contribute to symptoms of HSDD.

To be eligible to participate in the study, women with HSDD must have gone through menopause, either surgically or naturally, and have at least one risk factor for heart disease or stroke, such as diabetes, high blood pressure or age older than 70.

"Women will randomly be assigned to receive either the testosterone gel, which they will apply daily to the arm, or an identical placebo gel (inactive substance). They will receive the treatment for a minimum of a year at which time BioSante plans to seek FDA approval to market LibiGel. Study subjects will be followed up for another 4 years," Snabes said.

The primary aim of the study is to ensure that the testosterone gel does not increase the risk of cardiovascular events, such as a heart attack or stroke, or the risk of breast cancer.

"The FDA [Food and Drug Administration] has requested this preapproval study," Snabes said, "due to a perceived risk of cardiovascular events and breast cancer with the use of testosterone in women, despite no clear evidence of this."

"This new type of study," he continued, "shows the public that pharmaceutical companies and the FDA are willing to provide an increased level of assurance of drug safety prior to approval."

Other research has found that testosterone effectively treats HSDD, with "few serious adverse events associated with its use," Snabes said. However, there are no long-term studies of testosterone use in women. The Endocrine Society has called for more long-term data.
-end-
For more information about the study, e-mail libigel@biosantepharma.com.

Founded in 1916, The Endocrine Society is the world's oldest, largest, and most active organization devoted to research on hormones, and the clinical practice of endocrinology. Today, The Endocrine Society's membership consists of over 14,000 scientists, physicians, educators, nurses and students in more than 80 countries. Together, these members represent all basic, applied, and clinical interests in endocrinology. The Endocrine Society is based in Chevy Chase, Maryland. To learn more about the Society, and the field of endocrinology, visit our web site at www.endo-society.org.

The Endocrine Society

Related Heart Attack Articles from Brightsurf:

Top Science Tip Sheet on heart failure, heart muscle cells, heart attack and atrial fibrillation results
Newly discovered pathway may have potential for treating heart failure - New research model helps predict heart muscle cells' impact on heart function after injury - New mass spectrometry approach generates libraries of glycans in human heart tissue - Understanding heart damage after heart attack and treatment may provide clues for prevention - Understanding atrial fibrillation's effects on heart cells may help find treatments - New research may lead to therapy for heart failure caused by ICI cancer medication

Molecular imaging identifies link between heart and kidney inflammation after heart attack
Whole body positron emission tomography (PET) has, for the first time, illustrated the existence of inter-organ communication between the heart and kidneys via the immune system following acute myocardial infarction.

Muscle protein abundant in the heart plays key role in blood clotting during heart attack
A prevalent heart protein known as cardiac myosin, which is released into the body when a person suffers a heart attack, can cause blood to thicken or clot--worsening damage to heart tissue, a new study shows.

New target identified for repairing the heart after heart attack
An immune cell is shown for the first time to be involved in creating the scar that repairs the heart after damage.

Heart cells respond to heart attack and increase the chance of survival
The heart of humans and mice does not completely recover after a heart attack.

A simple method to improve heart-attack repair using stem cell-derived heart muscle cells
The heart cannot regenerate muscle after a heart attack, and this can lead to lethal heart failure.

Mount Sinai discovers placental stem cells that can regenerate heart after heart attack
Study identifies new stem cell type that can significantly improve cardiac function.

Fixing a broken heart: Exploring new ways to heal damage after a heart attack
The days immediately following a heart attack are critical for survivors' longevity and long-term healing of tissue.

Heart patch could limit muscle damage in heart attack aftermath
Guided by computer simulations, an international team of researchers has developed an adhesive patch that can provide support for damaged heart tissue, potentially reducing the stretching of heart muscle that's common after a heart attack.

How the heart sends an SOS signal to bone marrow cells after a heart attack
Exosomes are key to the SOS signal that the heart muscle sends out after a heart attack.

Read More: Heart Attack News and Heart Attack Current Events
Brightsurf.com is a participant in the Amazon Services LLC Associates Program, an affiliate advertising program designed to provide a means for sites to earn advertising fees by advertising and linking to Amazon.com.