Study is Key for Approval of First Drug for Female Sexual Dysfunction

	Tweet

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.

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.

Source: Endocrine Society

RELATED STORIES:
India to ask young villagers to encourage safe sex   Erectile Dysfunction Treatment May Also Treat Blood Vessel Narrowing in Rheumatic Diseases   Viagra may become available without prescription   Improving Sexual Relationships for Cancer Survivors   Nonsurgical Therapy Highly Effective for Pain and Infertility in Men   ED in younger men may foretell heart disease   Excess weight reduces men’s fertility   Evidence for acupuncture in impotence is weak   Abused girls may have higher risk of heart disease, stroke as adults   Childhood Sexual, Physical Abuse Linked to Drinking Problems in Women   Drug shows promise in treating dangerous complication of erectile disorder   Middle School Youth as Young as 12 Engaging in Risky Sexual Activity   For Many Men, A Correlation Between Lower Urinary Tract Symptoms and Sexual Dysfunction   Anti-impotence cream seen safe, effective   Work-based program helps parents talk about sex

Comments

[ + Post Your Own ]

Now you're in the public comment zone. What follows is not Armenian Medical Network's stuff; it comes from other people and we don't vouch for it. A reminder: By using this Web site you agree to accept our Terms of Service. Click here to read the Rules of Engagement.

There are no comments for this entry yet. [ + Comment here + ]