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    Menopause News

" 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
                women.

                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
               of estrogen.

                "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
                Medicine.

               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
                even further.

                "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.
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