Data released from a second, large-scale safety and efficacy study showed
treatment with Intrinsa, an investigational female testosterone patch,
significantly increased satisfying sexual activity and sexual desire in
menopausal women with Hypoactive Sexual Desire Disorder (HSDD), and who
previously had both ovaries removed. HSDD is defined as a lack of sexual desire
that causes a woman personal distress. The preliminary findings of the study
were presented today at ENDO 2004, the 86th Annual Meeting of The Endocrine
Society.
"These impressive study results add to the strong foundation of evidence
around the benefits of testosterone therapy via a patch for restoring sexual
desire in surgically menopausal women," said John Buster, M.D., lead study
investigator and Director of the Division of Reproductive Endocrinology and
Infertility at the Baylor College of Medicine in Houston, Texas. "Back-to- back
trial results of this depth and consistency in the field of female sexual
function are important for physicians and patients alike. The surgically
menopausal women I see in my practice everyday paint a very clear picture of how
common and concerning a loss of desire can be, and how real the need is for
therapeutic options."
The study of 533 surgically menopausal women with HSDD showed patients
receiving testosterone via a transdermal patch experienced a statistically
significant increase (p=0.001) in the frequency of total satisfying sexual
activity, as well as a statistically significant increase (p=0.0006) in sexual
desire versus placebo. Significant improvements were also seen in arousal,
orgasm, pleasure, responsiveness, concerns, self-image and distress levels for
women using the female testosterone patch. Overall, adverse events (AEs) were
similar in the testosterone and placebo groups. Although the overall incidence
of androgenic AEs was low, the incidence was slightly higher in the testosterone
group. Most of the androgenic AEs were mild and did not result in study
discontinuation.
A study of 562 surgically menopausal women with HSDD, which yielded
consistent results, was presented last month at a major medical meeting of
obstetricians and gynecologists.
Testosterone is produced naturally in a woman's ovaries and adrenal glands
and has long been linked to female sexual function. When a woman has her ovaries
surgically removed, she experiences an immediate decline in testosterone. The
loss of sexual desire can be associated with this testosterone drop. According
to a recent study, an estimated one in three surgically menopausal women in the
U.S. has low sexual desire and nearly half of these women report being
distressed about it(1). Low desire is the most commonly reported type of female
sexual health complaint.