Below you will find three articles. The first is from the
Associated Press, and the second is from the manufacturer,
Procter & Gamble, and the third is from WebMD.
Viagra, be cautious about expectations. I have written elsewhere
about the couples I worked with who were so excited when Viagra
came out. It was as if a sustained, hard erection would solve
all the problems. No way! It did for some, and it created
continued problems for others.
I do have
great hope, however, and you might choose to be hopeful as
New patch revs up sex life after menopause
Experimental testosterone treatment helps women spice things
By Marilynn Marchione, Associated Press – 10/20/04
PHILADELPHIA -- Menopausal women had more sex and were happier
about it when using an experimental hormone patch hailed by
some as a possible female equivalent of Viagra, doctors reported
Women on the testosterone patch had sex about four times
more than they usually did in two months compared to only
one additional session for women given a fake patch containing
no hormone, a study found. Those who got real patches also
reported more arousal, pleasure and orgasms, and had better
"We found an increase in activity, an increase in desire
and a decrease in distress," said Dr. Robin Kroll, a
Seattle gynecologist who reported results of the study Tuesday
at a meeting of infertility specialists. The research was
sponsored by Procter & Gamble Pharmaceuticals, which is
developing the patch, called Intrinsa, with Watson Pharmaceuticals
It was the first big test of the patch in women who went
through menopause naturally and complained of low sex drive.
A previous study in women who became menopausal because of
surgery found similar results, and the companies already have
asked the federal Food and Drug Administration to approve
its use for those women.
"The testosterone patch looks very promising. It may
be the answer for what women are looking for a libido lag
in menopause," said Dr. Marian Damewood, a University
of Pennsylvania gynecologist who is president of the American
Society for Reproductive Medicine.
As many as 30 million American women will have gone through
natural menopause by 2005 and another 10 million will be menopausal
because of having their ovaries removed, Procter & Gamble
Lack of interest in or pleasure from sex is a big problem
for such women, partly because of the decline in testosterone.
Even though men make far more of this hormone than women,
females still need a certain amount of it to have healthy
sex lives, experts say.
Taking testosterone pills isn't advised because it can cause
excessive hair growth, liver complications and other problems.
Testosterone creams that are applied to the inner thigh are
an option, but they've gotten little scientific study, Damewood
She had no role in the patch study, which involved 549 women
in Seattle, Denver, Boston, Canada and Australia, averaging
54 years old, who were upset because they didn't feel like
having sex. They were assigned to get either hormone or placebo
patches. All kept logs of their sexual activities and filled
out standard questionnaires about their feelings.
Those on the hormone patch improved in all measures. Side
effects were mild and reported by three out of four women
in each group -- mostly excess facial hair and red or irritated
skin from the patch, Kroll said.
"None of those patients wanted to stop taking the testosterone,"
The experiment was done over six months, the longest period
of time the patch has been tested.
Meanwhile, a survey of 2,000 American women sponsored by
Procter & Gamble and done by the Robert Wood Johnson Medical
School in New Jersey found that one in three naturally menopausal
women reported lackluster sex lives, but only one in 10 said
it upset them.
P&G Intrinsa For Female Sexual Dysfunction To Get
Cmte. Review In December
Procter & Gamble’s testosterone transdermal patch
Intrinsa will be considered for the treatment of hypoactive
sexual desire disorder in surgically menopausal woman receiving
concomitant estrogen therapy by FDA’s Reproductive Health
Drugs Advisory Committee at its Dec. 2 meeting.
P&G recently announced that the NDA (21-769) for the
testosterone patch was submitted to FDA in early summer and
is receiving a priority review, giving the product an estimated
user fee deadline of December 2004 or January 2005.
If approved, Intrinsa would be the first treatment for female
sexual dysfunction. It is estimated that about 40 mil. woman
experience some form of impaired sexual function.
P&G cited Intrinsa as the company’s “next
major opportunity” in the pharmaceutical market and
has been priming for market entry. The company expects a July-December
2005 launch. P&G licensed Intrinsa from TheraTech, now
The Intrinsa NDA is based on the INTIMATE SM 1 and 2 trials
in surgically menopausal women taking estrogen.
In the 562-patient INTIMATE SM 1 trial, women using the testosterone
patch had a 74% increase in the frequency of satisfying sexual
activity and a 56% increase in sexual desire from baseline.
Intrinsa patients reported an average 2.13 episodes of sexual
activity in four weeks compared to .98 episodes for placebo
patients, P&G reported.
The 533-patient INTIMATE SM 2 trial found a 51% increase
in the frequency of total satisfying sexual activity with
a mean increase of 1.56 episodes every four weeks compared
to .73 for placebo.
There was also a 49% increase in sexual desire (10.6 points
vs. 4.3 points for placebo). Significant improvements were
also seen in arousal orgasm pleasure, responsiveness, concerns,
self-image and distress levels, based on the Profile of Female
Sexual Function and Personal Distress Scale, P&G reported.
P&G has two ongoing Phase III trials in naturally menopausal
women with hypoactive sexual desire disorder (HSDD). The company
expects to present results at major medical meetings this
FDA Rejects Libido Drug for Women
Panel Cites Lack of Long-Term Safety Information for Intrinsa
By Todd ZwillichWebMD Medical News Reviewed By Brunilda Nazario,
MDon Thursday, December 02, 2004
Dec. 2, 2004 - An FDA advisory panel refused to recommend
approval of a new testosterone skin patch to treat low libido
in women, saying that its manufacturer did not provide enough
evidence that it is safe for long-term use.
The panel voted unanimously that Procter & Gamble, which
sought to market Intrinsa, did not have sufficient data to
show that prolonged exposure to testosterone is safe in women.
The company wants to market Intrinsa as a way to boost waning
sexual desire in women who have had their ovaries surgically
Women would wear the patch on their skin, where it delivers
a steady amount of testosterone, the male sex hormone known
to help stimulate sexual desire. Testosterone is also made
by the ovaries in tiny amounts, which is why the company wants
to limit the drug to women with removed ovaries. Women would
change the patch twice a week.
Company officials estimate that as many as 900,000 women
qualify as candidates for the testosterone patch. A projected
5,500 new patients could take the drug each year, but others
caution that many women who are not good candidates for Intrinsa
would be tempted to use the drug to improve their sex lives.
FDA scientists quickly raised doubts about Intrinsa's benefits
and questioned whether the modest improvements in women's
sex lives shown in studies are worth the drug's potential
Women in the company's clinical trial reported that they were
able to enjoy an average of five "satisfying sexual experiences"
per month, up from an average of three before they started
using the patch. But at the same time, women using a placebo
patch reported that their number of satisfying experiences
increased from three to four.
Roslyn Washington, a patient who participated in an Intrinsa
study, said the drug helped restore a "healthy and satisfying"
sex life and her libido, which dropped sharply after a hysterectomy
10 years ago.
"I would like to experience those feelings again,"
she told the panel.
Daniel Davis, MD, a reviewer with the FDA's Division of Reproductive
and Urologic Drug Products, pointed out that Intrinsa only
appeared to offer women one more satisfying sexual session
per month than a placebo patch.
"The key issue for us is really the clinical significance
of the findings," Davis said.
Concerns About Cancer, Cardiovascular Risks
Other officials cautioned that the company's one-year study
did not follow patients for a long enough time to address
the long-term health consequences of taking hormones. Data
suggest that testosterone supplementation can raise blood
pressure and alter cholesterol levels, raising concerns that
the patch can increase the risk of cardiovascular disease.
"It is too small a safety database for any reasonable
assessment of cardiovascular risk," said Steven Nissen,
MD, a cardiologist from The Cleveland Clinic and a voting
consultant to the committee.
"It is not an acceptable trade-off, and we cannot allow
this to move forward until we have such data," he said.
Hormone therapy also raises lingering questions about breast
In the studies on the patch, the average blood level of testosterone
in women using Intrinsa increased 4.5-fold by 52 weeks.
Some studies have shown higher-than-normal testosterone levels
in many women with breast
cancer, but any relationship between testosterone and tumors
remains essentially unknown.
Three women using Intrinsa and one using the placebo were
diagnosed with breast cancer during clinical trials, though
too little data exist to determine if the cancers were connected
to the drug, said FDA scientist Lisa M. Soule, MD.
"The current safety database is unable to answer many
questions about the long-term safety," Soule told the
Fears of the risks of long-term hormone medication have risen
since the release in 2002 of a study known as the Women's
Health Initiative (WHI). That study was halted after revealing
that a popular hormone replacement therapy containing estrogen
and progestin and taken by millions of menopausal women increased
the risk of heart disease and breast cancer.
Procter & Gamble sought Intrinsa's approval while the
FDA is under heavy scrutiny over its handling of several drug
safety issues including Merck's recent withdrawal of the pain
drug Vioxx and new warnings of suicide risk associated with
antidepressants in children.
Procter & Gamble officials unveiled a planned program
using insurance claims records to closely monitor the patch's
safety once it is on the market. The plan includes five years
of tracking by an independent expert panel that would report
directly to the FDA on its findings.
"P&G Pharmaceuticals will monitor the long-term
safety of Instrinsa. We are committed to making this happen,"
said Michael Steinbuch, PhD, the scientist in charge of post-market
Several witnesses warned of Intrinsa's potential for being
prescribed to women who are on a quest for sexual stimulators
but aren't good candidates for the drug. Some media coverage
has already billed the drug as a women's version of erectile
dysfunction drugs marketed for men with waning sex lives.
"It may well be promoted with a giggle and wink as the
female Viagra. Not so," said Leonnore Tiefer, PhD, a
New York psychologist and sex therapist who testified in front
of the panel.
Company officials stressed that they intend the drug only
for the narrow group of women defined by the drug's proposed
SOURCES: Daniel Davis, MD, reviewer, Division of Reproductive
and Urologic Drug Products, FDA. Lisa M. Soule, MD, Division
of Reproductive and Urologic Drug Products, FDA. Michael Steinbuch,
PhD, director of pharmacovigilance and epidemiology, Procter
& Gamble. Leonnore Tiefer, PhD, psychologist and sex therapist,
New York. Steven Nissen, MD, cardiologist, The Cleveland Clinic.
© 2004 WebMD Inc. All rights reserved.