Older Women Needed to Test First Drug for Sexual
Dysfunction in Postmenopausal Women
LibiGel first for women with absence of sexual
fantasies, thoughts and desires, which causes distress and lower sexual
activity
June
16, 2008 Older women age 50 to 80 suffering with hypoactive sexual
desire disorder (HSDD) are needed 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 today at
The Endocrine Societys 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 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 womans 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.
June
16, 2008 Older women age 50 to 80 suffering with hypoactive sexual
desire disorder (HSDD) are needed 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 today at
The Endocrine Societys 90th Annual Meeting in San Francisco.
Older men frequent victims of both diseases
should be on the alert