This is great for those of you who can not
take large doses of estrogen.
Many of the stores do not have it in sotck,
but will order it for you."
(FDA Approves World's Smallest Transdermal
Estrogen Delivery System)
MIAMI, FL -- Jan. 11, 1999 -- The United States Food and Drug
Administration has approved Noven Pharmaceuticals, Inc.’s second generation
transdermal estrogen delivery system (transdermal 17(beta)-estradiol) for the
treatment of the symptoms of menopause.
The new product is the smallest transdermal estrogen patch ever approved. The
patch is expected to be marketed and sold in the U.S. by Vivelle Ventures LLC.
Slightly larger than a nickel, the patch is less than half the size of any other
estrogen patch on the U.S. market and less than one-third the size of the current
market leader. Available in four dosage strengths (.0375, .05, .075 and .10
mg/day), the patch provides prescribing physicians with greater dosing flexibility
than competitive products.
The new patch, which is applied twice per week, delivers 17(beta)-estradiol
through the skin and into the bloodstream. 17(beta)-estradiol is identical to a
woman's own estrogen, unlike those estrogen therapies derived from equine sources.
Estrogen Plus Androgen Therapy Improves
Libido, Reduces Hot Flashes
COPENHAGEN, DENMARK -- August 8, 1997 -- Adding small amounts of
androgen to estrogen replacement therapy can restore failing libido, resolve
persistent hot flashes and restore decreased bone density, all consequences of
menopause that can affect the quality of life and health of postmenopausal
These findings and others were presented at a symposium entitled "The
Emerging Role of Estrogen-Androgen Therapy in the Care of the
Postmenopausal Patient," at the XV World Congress of Gynecology and
Obstetrics, in Copenhagen, Denmark yesterday.
Androgens are hormones produced in the ovaries and adrenal glands that act on
the musculoskeletal, nervous, hepatic and vascular tissues. Women actually
make more androgens than estrogens daily and convert the androgens to
estrogens. In adult women, androgens have long been known to play a key role
in sexuality and to prevent bone loss and increase bone density.
Like estrogen, androgen production drops significantly after menopause. Yet the
impact of postmenopausal androgen decline has been far less studied than that
"Androgen, for some women, is the 'missing hormone' of their postmenopausal
years," said Dr. Elizabeth Barrett-Connor, who moderated the symposium and
is a world-renowned expert in menopause research and professor and chief of
the division of epidemiology at the University of California, San Diego, School of
These findings are exciting because they add to a growing body of research
showing one-size-doesn't-fit-all in hormone replacement therapy,” she added.
“Hormone therapy should be tailored to each individual according to symptoms,
and combination estrogen-androgen therapy can be a significantly better option
for some women than estrogen alone."
Loss of Libido a Common, Untreated, Symptom
Many postmenopausal women experience a sharp drop in sex drive and the
enjoyment and frequency of orgasm.
"The decline of androgen levels after menopause is an important factor in the
decline of sexual interest, yet libido remains a subject that many postmenopausal
women -- and their doctors – are uncomfortable discussing," said Dr. Alex
Vermeulen, MD, Ph.D., professor of medicine, University of Ghent, Belgium.
"But sexuality should be just as much a part of life after menopause as before."
In his presentation, Dr. Vermeulen noted that because the ovaries continue to
secrete minute amounts of androgens even after menopause, women who have
undergone oophorectomy (surgical removal of the uterus and ovaries) have even
lower androgen levels than do women in natural menopause. Surgically
menopausal women -- frequently younger and less prepared for the onset of
menopausal symptoms -- may go untreated.
Dr. Vermeulen cited other potential benefits of estrogen-androgen therapy,
including improvements in memory abilities, increase in lean body mass and
prevention of bone loss.
Promising News About Osteoporosis
Postmenopausal women are at increased risk for osteoporosis, a bone-thinning
disease that can cause significant physical disability and shorten life expectancy.
Estrogen taken after menopause has been proven to slow bone loss. But in
several investigations of both postmenopausal and surgically menopausal
women, estrogen plus androgen therapy was shown to not only slow bone loss,
but also to stimulate bone formation. Oral estrogen-androgen therapy
significantly increased bone mineral density in two, two-year studies, particularly
in women who had not taken estrogen in the previous two years.
Broadened Spectrum of Menopausal Symptom Relief
Dr. Philip Sarrel, professor of obstetrics and gynecology and psychiatry, Yale
University School of Medicine, called for a re-evaluation of the role of
androgens in the treatment of postmenopausal symptoms at the time of
menopause, and continuing until ten years later, when androgen levels decline
"The notion that menopause is a one-or two-year 'event' is an outdated way of
looking at what is really a spectrum of symptoms, over as long as a decade, for
many women," said Dr. Sarrel. "Androgen production, except in women
undergoing surgical menopause, decreases gradually over the years leading up to
menopause and for a decade later. As a result, symptoms due to androgen
depletion, if any, are to be expected as the menopausal transition begins to
persist into late menopause."
According to Dr. Sarrel, these symptoms, observed in surgically menopausal
women receiving estrogen replacement therapy, can include more severe and
frequent hot flashes, more and longer-lasting symptoms due to urogenital
atrophy and a greater frequency of psychologic difficulties, including mental
depression and loss of libido.
"Women who received estrogen plus androgen showed an improvement in
sexual desire, fantasy, response and frequency and a decrease in dyspareunia
compared with women who received estrogen alone," said Dr. Sarrel.
Dr. Sarrel also discussed findings of a separate study of 252 women that
showed 50 percent of women using estrogen-only therapy and women not
taking any therapy both reported decreased libido.
Also presented was a study showing improvement in symptom relief (hot flashes,
insomnia and vaginal dryness) when androgens are added to estrogen regimens.
"Estrogen in optimal doses provides adequate relief of hot flashes in most
women, but a proportion of treated women remain dissatisfied with residual
unresolved symptoms, even after taking estrogen," said Dr. Barrett-Connor.
Treatment needs to be customized to each individual woman in order to obtain
complete relief of persistent vasomotor symptoms.