| Saturday, May 27, 2006 |
| FDA Approves Duramed's SEASONIQUE(TM) Extended-Cycle Oral Contraceptive |
Barr Pharmaceuticals, Inc. (NYSE: BRL) today announced that the U.S. Food and Drug Administration (FDA) has approved its Duramed Pharmaceuticals, Inc.'s New Drug Application (NDA) for SEASONIQUE(TM) (levonorgestrel/ethinyl estradiol tablets 0.15 mg/0.03 mg and ethinyl estradiol tablets 0.01 mg) extended-cycle oral contraceptive for the prevention of pregnancy. SEASONIQUE represents the next generation of extended-cycle oral contraceptives in a category the Company created with the launch of the SEASONALE(R) extended-cycle oral contraceptive in 2003.
SEASONIQUE will be shipped to trade customers and will be available by prescription to women in July 2006. The Company intends to immediately initiate multiple marketing programs aimed at healthcare providers and patients. The Company will initiate full scale detailing for SEASONIQUE to healthcare providers in August using its Duramed Sales Forces. Information about SEASONIQUE will be available at http://www.SEASONIQUE.com.
"SEASONIQUE joins SEASONALE in offering American women a new option in extended-cycle oral contraception," said Bruce L. Downey, Chairman and CEO of Barr Pharmaceuticals, Inc. "The science involving extended-cycle oral contraceptives continues to evolve and SEASONIQUE represents an exciting and unique development in this category. SEASONIQUE provides continuous hormonal support in the form of a low-dose of estrogen in place of the seven placebo pills. There is no other product like SEASONIQUE on the market today."
Downey continued, "We believe that our SEASONIQUE product line, including our Lo SEASONIQUE(TM) product that is currently in Phase III clinical studies, as well as other extended-cycle oral contraceptive products also in development, expands our commitment and leadership to a franchise that provides women with the option of four periods per year and low dose estrogen instead of a hormonal free interval."
The Company's application for SEASONIQUE had received an Approvable Letter in August 2005. In March 2006, the FDA notified the Company that it had determined that additional clinical studies would not be required to support the approval of SEASONIQUE. Following this notification, the Company submitted product labeling that has now gained approval.
SEASONIQUE
Under the SEASONIQUE extended-cycle regimen, women take active tablets of 0.15 mg of levonorgestrel/0.03 mg of ethinyl estradiol for 84 consecutive days, followed by seven days of 0.01 mg of ethinyl estradiol. The regimen is designed to reduce the number of withdrawal bleeding periods from monthly to four per year. The clinical data supporting the SEASONIQUE NDA resulted from one large pivotal randomized, open-label, multi-center trial and one supportive randomized, open-label, multi-center trial, both of which ended in April 2004. The trials involved approximately 2,500 female patients between the ages of 18-40 at 43 sites in the United States. Patients were enrolled in the pivotal trial for the duration of 12 months (four (4) 91-day cycles).
Important Information About Oral Contraceptives
It is estimated that more than 16 million women currently take oral contraceptives in the United States. Oral contraceptives are not for every woman. Serious as well as minor side effects have been reported with the use of hormonal contraceptives. Serious risks include blood clots, stroke, and heart attack. Cigarette smoking increases the risk of serious cardiovascular side effects, especially in women over 35 years. Oral contraceptives do not protect against HIV infection (AIDS) and other sexually transmitted diseases.
Barr Pharmaceuticals, Inc. |
| posted by Jennie Tate @ 4:48 AM |
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| Thursday, May 25, 2006 |
| New Book Looks At Menstrual Disorders In Primary Care |
Many menstrual irregularities can be traced to medical problems that, if left unresolved, can profoundly affect women's health. Moreover, many menstrual disorders can and should be managed by primary care physicians. To help internists and other primary care providers treat the medical causes and implications of menstrual disorders, ACP this spring released the latest title in its acclaimed Women's Health book series, "Menstrual Disorders."
The book provides a detailed discussion of the range of menstrual disorders that patients may experience from menarche through menopause and the relationship between menstrual disorders and other medical illnesses.
"It is the first book on menstrual disorders that my co-editors and I are aware of that blends the fields of gynecology, adolescent medicine, internal medicine and other medical subspecialties into one comprehensive, integrated volume," said Deborah B. Ehrenthal, MD, FACP, assistant residency program director for the obstetrics and gynecology program at Christiana Care Health System in Wilmington, Del.
Dr. Ehrenthal co-edited the book with Matthew K. Hoffman, MD, MPH, FACOG, of the Department of Obstetrics and Gynecology at Christiana Care Health System and Paula J. Adams Hilliard, MD, of the University of Cincinnati College of Medicine.
"Menstrual Disorders" covers menstrual, contraceptive and reproductive issues for women with chronic medical problems. These issues affect a growing number of patients being cared for by internists.
The book includes chapters on caring for women with polycystic ovary syndrome and on the complex menstrual and contraceptive management of women with disabilities. One chapter guides clinicians through the evaluation and management of bleeding disorders, including von Willebrand's Disease. The book also provides an overview of procedures used in managing abnormal uterine bleeding, with old and new treatment modalities including endometrial ablation and uterine artery embolization.
The ACP Women's Health Series provides in-depth coverage of diseases, disorders, and health and wellness issues unique to female patients. The series gives physicians the knowledge they need to optimize patient care, from the initial approach to the patient through diagnosis, treatment and long-term management. Other titles include, "Breast Health and Common Breast Problems: A Practical Approach," "Coronary Artery Disease in Women," and "Medical Care of the Pregnant Patient."
ACP (Doctors of Internal Medicine. Doctors for Adults.(R)) is the largest medical-specialty organization and second-largest physician group in the United States. Membership includes more than 119,000 internists, related subspecialists, medical students, residents and fellows. Internists specialize in the prevention, detection and treatment of illnesses in adults.
The American College of Physicians was founded in 1915 to promote the science and practice of medicine. In 1998 it merged with the American Society of Internal Medicine, which was established in 1956 to study economic aspects of medicine. ACP works to enhance the quality and effectiveness of health care by fostering excellence and professionalism in the practice of medicine. Its publishing program includes the journal Annals of Internal Medicine, electronic products, and books for the medical community and general reader. For more information, visit http://www.acponline.org
Lynda Teer
lteer@acponline.org
American College of Physicians |
| posted by Jennie Tate @ 7:58 AM |
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| Monday, May 22, 2006 |
| New Alternative To Hip Replacement Designed For Patients With Active Lifestyles |
There is a new option for patients suffering from hip pain who do not want to give up their active lifestyle. NewYork-Presbyterian/Columbia University Medical Center is one of the first hospitals in the U.S. to offer a new alternative for total hip replacement-hip resurfacing. The technique allows the orthopedic surgeon to shave and cap several centimeters of bone within the hip joint, helping to preserve bone and joint stability for young or active patients.
The Innovative Birmingham Hip Resurfacing™ System preserves more of the patient's natural bone structures and stability, covering the joint's surfaces with an all-metal implant that more closely resembles a tooth cap than a hip implant. This approach reduces post-operative risks of dislocation and inaccurate leg length, and because the all-metal implant is made from durable, smooth cobalt chrome, it has the potential to last longer than traditional hip implants.
"Hip resurfacing is ideal for many of my young, active patients who suffer from hip pain. As we've seen greater numbers of younger patients and older patients that are physically active, there's been an increased need for an alternative to total hip replacement that accommodates their age and lifestyle," says Dr. William B. Macaulay, director of the Center for Hip and Knee Replacement at NewYork-Presbyterian Hospital/Columbia, and associate professor of orthopaedic surgery and advisory dean at Columbia University College of Physicians and Surgeons.
The FDA-approved procedure is indicated for patients under that age of 60 who live non-sedentary lifestyles and suffer from hip pain due to a variety of diseases which affect the hip joint.
Total hip replacement involves the removal of the entire femoral head and neck. The hip resurfacing technique, however, leaves the head and neck untouched. It is this neck length and angle that determines the natural length of a patient's leg after surgery, and since it is not removed and replaced with an artificial device during the resurfacing procedure, there is a greater likelihood of maintaining accurate leg length.
While the implant closely matches the size of a patient's natural femoral head (hip ball), it is substantially larger than the femoral head of a traditional total hip replacement implant. This increased size translates to greater stability in the new joint, and it decreases the chance of dislocation of the implant after surgery. Dislocation is a leading cause of implant failure after total hip replacement.
The Birmingham Hip implant is an all-metal ball and socket joint. Traditional hip replacements use a metal ball and a plastic socket. This plastic socket wears down over time, and may need to be replaced surgically. In fact, it is a leading cause of follow-up surgeries.
The Innovative Birmingham Hip Resurfacing™ System is manufactured by Smith & Nephew Inc. of Memphis.
NewYork-Presbyterian Hospital/Columbia University Medical Center
NewYork-Presbyterian Hospital/Columbia University Medical Center, located in New York City, is one of the leading academic medical centers in the world, comprising the teaching hospital NewYork-Presbyterian and its academic partner, Columbia University College of Physicians and Surgeons. NewYork-Presbyterian/Columbia provides state-of-the-art inpatient, ambulatory and preventive care in all areas of medicine, and is committed to excellence in patient care, research, education and community service. NewYork-Presbyterian, which is among U.S. News & World Report's top 10 hospitals nationally, also comprises NewYork-Presbyterian Hospital/Weill Cornell Medical Center and its academic affiliate, Weill Medical College of Cornell University.
NewYork-Presbyterian Hospital/Columbia University Medical Center
627 West 165th Street
New York, NY 10032
http://www.nyp.org |
| posted by Jennie Tate @ 4:02 AM |
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| Friday, May 19, 2006 |
| Cutting Calories Slightly Can Reduce Aging Damage |
A lifelong habit of trimming just a few calories from the daily diet can do more than slim the waistline - a new study shows it may help lessen the effects of aging.
Scientists from the University of Florida's Institute on Aging have found that eating a little less food and exercising a little more over a lifespan can reduce or even reverse aging-related cell and organ damage in rats.
The discovery, described this month in the journal Antioxidants and Redox Signaling, builds on recent research in animals and humans that has shown a more drastic 20 percent to 40 percent cut in calories slows aging damage. The UF findings indicate even small reductions in calories could have big effects on health and shed light on the molecular process responsible for the phenomenon, which until now has been poorly understood.
"This finding suggests that even slight moderation in intake of calories and a moderate exercise program is beneficial to a key organ such as the liver, which shows significant signs of dysfunction in the aging process," said Christiaan Leeuwenburgh, Ph.D., an associate professor of aging and geriatric research at the UF College of Medicine and the paper's senior author.
UF scientists found that feeding rats just 8 percent fewer calories a day and moderately increasing the animals' activity extended their average lifespan and significantly overturned the negative effects of cellular aging on liver function and overall health.
An 8 percent reduction is the equivalent of a few hundred calories in an average human diet and moderate exercise is equivalent to taking a short walk.
To reveal the workings of the body's chemical climate when aging-related damage happens, UF researchers tracked levels of biomarkers - chemicals and molecules present in the liver - in groups of rats. The liver, a crucial organ for maintaining good health during aging, cleans the blood and helps regulate the body's immune system. The researchers also plan to assess the same biomarkers in a study of rats' hearts, muscle and brains.
The research team was surprised to find one of the biomarkers, RNA, which is important for coding DNA and for protein synthesis, is more quickly damaged by aging than the more frequently studied DNA. RNA damage, therefore, could be an excellent early signal to indicate the onset of aging, researchers say.
"Because it is more sensitive to oxidative stress, RNA can be useful as an early marker of oxidative damage and even aging," said Arnold Y. Seo, a doctoral student in UF's Institute on Aging.
Seo authored the report along with Tim Hofer, Ph.D., an Institute on Aging research associate.
"To avoid disease, we can increase our defense and look for aging biomarkers and then test interventions," Hofer said. "It is better to protect what is there to improve the quality of life than to have to resort to invasive procedures."
In the study, which followed the rats over their lifespan, one group of animals ate as much food as they wanted and did not exercise, another group of animals exercised lightly and were fed slightly less than they would have eaten if allowed to have their fill. Liver samples from these groups were compared with samples taken from young rats.
The old sedentary rats that ate until they were full had increased levels of harmful oxidizing and inflammatory molecules in the liver that were associated with cell damage caused by aging. Meanwhile, aging rats that exercised and consumed a calorie-restricted diet, had the reverse outcome - they showed a decrease in these molecules in the liver.
Leeuwenburgh said the study results support the theory that cell death and aging-related organ damage are caused by unstable molecules known as free radicals and by cellular oxidation and inflammation.
"In a calorie-restricted environment, you reduce the inflammatory response and prevent cell death," Leeuwenburgh said.
John O. Holloszy, a professor of medicine in the division of geriatrics and nutritional sciences at Washington University School of Medicine in St. Louis, said the study is of major importance because it shows a mild degree of caloric restriction - just enough to prevent weight gain with advancing age - can have beneficial effects against aging. From a scientific perspective, he added, it is important to learn that RNA is a very good marker of aging damage.
"I'd never really thought about RNA before," Holloszy said. "Research has always looked at DNA. Because RNA is the template for the information on the genes on the DNA, RNA damage is a major problem because it results in mutations in the transcription of proteins."
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Contact: Denise Trunk
University of Florida |
| posted by Jennie Tate @ 8:06 AM |
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| Wednesday, May 17, 2006 |
| Study Identifies Substances In Grapefruit Juice That Interact Dangerously With Some Drugs |
New research from the University of North Carolina at Chapel Hill has identified and established the substance in grapefruit juice that causes potentially dangerous interactions with certain medications.
For almost a decade, people have been told by their doctors and pharmacists to avoid grapefruit juice if they are being treated with certain medications, including some drugs that control blood pressure or lower cholesterol. Studies have shown that grapefruit juice can cause more of these drugs to enter the blood stream, resulting in undesirable and even dangerous side effects.
The drugs affected by grapefruit juice usually have some difficulty entering the body after they are consumed because an intestinal enzyme, CYP3A, partially destroys them as they are absorbed. Grapefruit juice, but not other commonly consumed fruit juices, inhibits this enzyme, allowing more of these drugs to enter the body.
It was originally assumed that the ingredients responsible for drug interactions were the flavonoids that give grapefruit juice its bitter taste.
The new study shows that a group of chemicals called furanocoumarins are the likely culprit.
"This is the best evidence to date that furanocoumarins are the active ingredients in grapefruit juice that cause the interaction with medications," said Dr. Paul Watkins, the Dr. Verne S. Caviness distinguished professor of medicine and director of UNC's General Clinical Research Center (GCRC). Watkins led the study team.
A report of the new findings appears in the May issue of the American Journal of Clinical Nutrition.
To determine whether furanocoumarins are responsible for grapefruit juice-drug interactions, Watkins worked with scientists at the Florida Department of Citrus to selectively remove only the furanocoumarins from the juice. He and his collaborators then studied the effect of the whole juice versus furanocoumarin-free juice on the ability to affect absorption of felodipine, an anti-hypertension drug known to interact with grapefruit juice "And we found that removing the furanocoumarins from grapefruit juice entirely got rid of this interaction," Watkins said.
In this randomized study, 18 healthy volunteers took 10 milligrams of felodipine with each of three juices: orange juice, regular grapefruit juice, and grapefruit juice devoid of furanocoumarins. Blood was collected over 24 hours to measure felodipine blood levels. One week elapsed between each felodipine-juice "treatment."
The study found that in contrast to whole grapefruit juice, the furanocoumarin-free grapefruit juice behaved like orange juice and did not cause an interaction with felodipine.
Watkins notes that there are several implications of this work.
"First, it should now be possible to market the furanocoumarin-free grapefruit juice to patients who would otherwise need to avoid grapefruit. In addition, it should be possible to screen new foods for the potential for drug interactions by determining whether they contain furanocoumarins.
"Finally, it may be possible to add furanocoumarins to formulations of certain drugs that tend to be poorly or erratically absorbed to improve their oral delivery."
Contact: Leslie H. Lang
University of North Carolina School of Medicine |
| posted by Jennie Tate @ 9:41 AM |
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| Saturday, May 13, 2006 |
| Rapid Return To Menses Once Oral Contraception Stopped, Study Shows |
A study by a Columbia University Medical Center researcher shows that 99 percent of participants experienced either a return to menstruation or became pregnant within 90 days after stopping an investigational, low-dose oral contraceptive taken every day without placebo. Findings from the first large clinical examination were presented this week at the American College of Obstetricians and Gynecologists (ACOG) Annual Clinical Meeting in Washington, D.C.
Anne R. Davis, M.D., assistant professor of clinical obstetrics and gynecology at Columbia University Medical Center, presented the findings abstract relating to a non-cyclic oral contraceptive, [90 µg levonorgestrel/20 µg ethinyl estradiol tablets], that would be taken every day of the year without a placebo interval. In contrast to a 28-day cyclic regimen, this regimen would be taken every day of the year, without a placebo (or sugar pill) interval, resulting in a temporary interruption of menses.
The follow-up study after a Phase 3, multicenter, open-label study of the safety and contraceptive efficacy of a non-cyclic oral contraceptive investigated return to menstruation after study participants stopped taking the contraceptive. Results showed that 185 of the 187 women in the study experienced either a return to menses or became pregnant within 90 days once they stopped the study drug after taking it for a median of 364 days. Four women became pregnant before returning to menses and two women reported a return to menses more than 90 days after the completion of the study.
"Patients want to know if, after taking an oral contraceptive every day without placebo pills, their menses will return," said Dr. Davis. "By evaluating this, we were able to learn that women who followed this daily regimen experienced a return to menses without a considerable delay."
The most widely used method of contraception in 1995 was oral contraceptives, used by 10.4 million women, according to National Survey of Family Growth (NSFG).
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Columbia University Medical Center provides international leadership in pre-clinical and clinical research, in medical and health sciences education, and in patient care. The medical center trains future leaders and includes the dedicated work of many physicians, scientists, nurses, dentists, and public health professionals at the College of Physicians & Surgeons, the College of Dental Medicine, the School of Nursing, the Mailman School of Public Health, the biomedical departments of the Graduate School of Arts and Sciences, and allied research centers and institutions. http://www.cumc.columbia.edu/
Contact: Elizabeth Streich
Columbia University Medical Center |
| posted by Jennie Tate @ 9:12 AM |
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| Friday, May 12, 2006 |
| Report Shows Popular Birth Control Pill, Ortho Tri-Cyclen(R) LO, Not Associated With Increased Pregnancy Risk In Heavier Women |
The popular birth control pill, ORTHO TRI-CYCLEN(R) LO (norgestimate/ethinyl estradiol) Tablets, is not associated with an increased risk of pregnancy in heavier women, according to findings(1) presented today at the 54th Annual Clinical Meeting of the American College of Obstetricians and Gynecologists (ACOG).
Previous research suggested that higher weight or body mass index (BMI) may compromise the efficacy of birth control pills leading to a greater number of unintended pregnancies.(2,3) This analysis evaluates the risk of pregnancy in heavier women using ORTHO TRI-CYCLEN LO.
"A significant number of women with a wide range of weights and BMIs were included in this analysis, creating a rich source of data to evaluate the association between body weight and efficacy," said Dr. Katherine LaGuardia, director, medical affairs, Ortho Women's Health & Urology. "These results reinforce ORTHO TRI-CYCLEN LO as an effective birth control option for women in a broad range of body weights."
Study Details
The report is based on a retrospective analysis of ORTHO TRI-CYCLEN LO Phase III efficacy data to determine the association of pregnancies with body weight and BMI, a standard measure of weight-for-height. The data were from 1,673 ORTHO TRI-CYCLEN LO users, weighing from 90 to 240 pounds, for 11,003 use cycles.
Investigators found that a total of 20 pregnancies occurred - 14 likely due to "method failure" (eg, the Pill did not work) and six due to failure on the part of the individual (eg, forgetting to take the Pill). This translated into a total pregnancy probability of 1.9 percent and a probability of failure of the Pill of 1.5 percent.
The probability of total and method-failure pregnancies was the same across different body weights. ORTHO TRI-CYCLEN LO users weighing 155 lbs. or more (n=435) did not experience significantly higher pregnancy risk than those less than 155 lbs. with either method-failure pregnancies (relative risk 1.03, p=0.95) or total pregnancies (relative risk 1.42, p=0.46). The results were the same when other weight criteria (median weight of 139 lbs. and over vs. less than 139 lbs., over 175 lbs. vs. less than or equal to 175 lbs., and 198 lbs. and over vs. less than 198 lbs.) and BMI criteria (25 and over vs. less than 25) were applied. The study was conducted and funded by Ortho Women's Health & Urology, a division of Ortho-McNeil Pharmaceutical, Inc.
About ORTHO TRI-CYCLEN LO (norgestimate/ethinyl estradiol) ORTHO TRI-CYCLEN LO is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as their method of contraception.
Important Safety Information
Serious as well as minor side effects have been reported with the use of oral contraceptives. Serious risks include blood clots, stroke and heart attacks. Cigarette smoking increases the risk of serious cardiovascular side effects, especially in women over 35. Women who use oral contraceptives are strongly advised not to smoke. The Pill does not protect against HIV or sexually transmitted diseases.
For more information about ORTHO TRI-CYCLEN LO, please visit http://www.thepill.com.
About Ortho Women's Health & Urology
Ortho Women's Health & Urology, a division of Ortho-McNeil Pharmaceutical, Inc., is a leader in the fields of women's health and urology and is committed to providing patients with products that help them to live healthier lives. Ortho Women's Health & Urology, a trusted partner of healthcare professionals, is committed to meeting the needs of providers and patients with products such as ORTHO EVRA(R) (norelgestromin/ethinyl estradiol transdermal system), ORTHO TRI-CYCLEN(R) LO (norgestimate/ethinyl estradiol), DITROPAN XL(R) (oxybutynin chloride), and ELMIRON(R) (pentosan polysulfate sodium).
Ortho Women's Health & Urology
http://www.thepill.com |
| posted by Jennie Tate @ 9:15 AM |
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| Wednesday, May 10, 2006 |
| New Drug May Offer Cool Relief Of Hot Flashes For Millions Of Women |
Hot flashes afflict most menopausal women, with some experiencing severe and disruptive hot flashes, seven or more times a day, for many years. Fortunately, new discoveries may offer relief -- without the use of controversial hormone replacement therapies.
Drs. Isaac Cohen and Mary Tagliaferri, and their team at Bionovo, Inc., have developed an oral drug designed to minimize a woman's vasomotor symptoms, such as hot flashes and night sweats. The non-steroidal estrogen-receptor beta compound is based on plant extracts discovered by Company scientists. Clinical studies demonstrated that the novel plant-based therapy is safe and well tolerated by menopausal women.
"At present, women contemplating hormone replacement therapy for relief of hot flashes and other menopause-related symptoms still face confusion and controversy," says Dr. Tagliaferri, Bionovo's Medical Director. "Many health professionals have no ready answers to offer women about the risk-benefit ratio with regard to the heart, breast, bone density, skin condition and other areas of the body that could be affected. This leaves women up in the air on the value of taking estrogen at all."
An alternative to estrogen: Bionovo's proprietary oral treatment, MF 101. The drug is now being tested in a multi-center, randomized, placebo-controlled Phase II Clinical Study, designed to evaluate, in postmenopausal women, the change in frequency and severity of hot flashes from baseline to 12 weeks. Dr. Deborah Grady, renowned authority figure on women's health at the University of California, San Francisco, is serving as the Principal Investigator of the study. Recruitment for the trial is also taking place at the University of Alabama, the University of Minnesota and the University of Tennessee.
The women in the trial, ages 40-60, experience seven or more hot flashes a day, or more than 50 a week. A total of 180 women are taking the drug for three months; 60 will be randomized to take dose one of MF101, 60 will take dose two, and 60 will receive a placebo.
For more information, visit Bionovo, Inc. |
| posted by Jennie Tate @ 10:35 AM |
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| New Male Contraceptive Targets Sperm, Not Hormones |
Men and women have long been promised a male version of the female contraceptive pill. But the first new male contraceptive to market may not be hormonal at all.
Researchers received Food and Drug Administration approval today for a 90-man study of the Intra Vas Device (IVD), a nonhormonal contraceptive that stops sperm in their tracks. The study, to take place in Seattle, Washington and St. Paul, Minnesota, will bring men one step closer to having their first new contraceptive in more than a century.
"Preliminary studies in animals and men show that this doesn't have the side effects of hormonal methods," said Jim Stice, president of Shepherd Medical Company, a consortium of researchers and entrepreneurs developing the device. "The concept is pretty simple: A set of tiny plugs block sperm as they travel through a tube called the vas deferens. Men don't need to worry that they'll have acne or gain weight or have their sex drive go up or down--all things that can happen when you manipulate hormones."
This will be the second contraceptive study of the IVD in men. In the pilot study, the method was very effective: All 30 men either had no sperm in their semen or had levels too low to cause a pregnancy. Early monkey studies showed reversibility after seven months of use, but reversibility studies in men have thus far only tested same-day insertion and removal.
Elaine Lissner, director of the nonprofit Male Contraception Information Project, is cautiously optimistic. "The Holy Grail of contraception is a long-term, reversible method without any hormonal side effects," she said. "Right now the IVD developers can't guarantee that it's reversible in men like it has been in animals, so they're billing it as a kinder, gentler vasectomy. But if it turns out to be reversible, they're going to have a line out the door."
Demand from Men
The concept of blocking sperm in the vas deferens is not new: each year about 500,000 American men get vasectomies, a simple 15-minute procedure in which the vas deferens is cut and its ends closed off. About one in six American men over 35 already has a vasectomy. However, vasectomy is generally considered permanent, leaving younger men with condoms as their only option.
Men in long-term relationships, such as Jacob Kostecka, 29, are likely to be the first ones interested in the IVD. "My wife doesn't want to take hormonal methods, and I don't blame her. I wouldn't want to take that stuff and have it mess with my body either! But most other methods are clumsy and ruin the moments of intimacy we have together. Something like this could be really appealing."
The news about the IVD comes on the heels of the announcement that RISUG, a vas deferens-based male contraceptive developed in India, will resume trials in men. RISUG has been shown reversible in animals. Researchers in China are also having success with a new vas deferens device, though theirs is not being billed as reversible.
Kirsten Thompson, director of the Male Contraceptive Coalition, stresses that men can help speed development of these methods. "Men clearly want to know about these options--our website gets thousands of visitors each week. But there are still questions to be answered about the IVD's reversibility," she said. She added that "Men who don't want any more children and live near a study site can help answer those questions by volunteering. Otherwise, the best thing they can do is spread the word."
The Male Contraception Information Project is entirely nonprofit and works in three areas: raising public awareness of promising non-hormonal male contraceptives, advocating increased and expedited government research, and serving as a resource for journalists who wish to write about the subject.
For more information on the IVD and other male contraceptive research, visit http://www.malecontraceptives.org/. For additional press resources, visit http://www.mcip.info/.
IVD research is supported by a grant from the National Institute of Child Health and Human Development.
Contact: Elaine Lissner
Male Contraception Information Project |
| posted by Jennie Tate @ 10:30 AM |
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| Saturday, May 06, 2006 |
| Nuvaring Better Tolerated Than Other Hormonal Contraceptives |
Nuvaring Better Tolerated Than Other Hormonal Contraceptives - Most Users Report Greater Feeling Of Safety And Control Over Their Lives.
Women who switch to NuvaRing - the once-a-month contraceptive ring - from other forms of hormonal contraception experience a significant reduction in hormone-related adverse events, according to results from a study involving 900 Spanish women presented today at the European Society of Contraception [1].
The study also showed that eight out of ten women reported an improvement in quality of life after starting NuvaRing. The reasons that contributed most to this improvement were a greater feeling of safety followed by a greater feeling of control over their lives.
Lead investigator, Dr Lete Lasa, consultant gynecologist commented: "It is easy to understand the growing popularity of NuvaRing among Spanish women in the context of these findings. NuvaRing is extremely well tolerated and women clearly appreciate the convenience of its once-a-month action."
NuvaRing is a highly reliable contraceptive offering the advantage of a once-a-month regimen, while minimizing women's exposure to estrogen. Comparative studies show NuvaRing offers superior cycle control to the Pill, while reducing the incidence of estrogen-related side effects.
Dr Lete Lasa attributed the low incidence of hormone-related adverse events with NuvaRing to its low and steady release of hormone. Previous research shows that total monthly serum exposure to estrogen is 3.4 times lower among women using NuvaRing than those using the transdermal patch, and 2.1 times lower than those using an oral contraceptive containing 30 mcg of estrogen. At the same time, NuvaRing users experience fewer fluctuations in blood hormone levels than women using the contraceptive patch or the pill do.
NuvaRing is proving particularly popular in Spain. Accordingly, Dr Lete Lasa and colleagues at the Santiago Apostol Hospital in Vitoria Spain set up a clinical experience program to investigate aspects of its use. They invited all women requesting contraceptive advice at a number of centres to participate in a six-month observational, prospective open study with NuvaRing. Women were classified as either new users of hormonal contraception if they were not previously using hormonal contraception or switchers if they switched to NuvaRing from another hormonal contraceptive.
The results showed that among switchers, the incidence of nausea, headache and breast tenderness was significantly lower after 3 cycles of NuvaRing use compared to baseline and this improvement was maintained and strengthened at cycle 6. More specifically, the percentage of women with breast hypersensitivity decreased from 6.4 % at baseline to 1.7 % after 6 cycles of use and headache fell from 10% at the start of the study to 1.2%.
About Organon
Organon - with shared head offices in Roseland, NJ, USA and Oss, The Netherlands - creates, manufactures and markets prescription medicines that improve the health and quality of human life. Through a combination of independent growth and business partnerships, Organon strives to remain or become one of the leading pharmaceutical companies in each of its core therapeutic fields: gynecology, fertility, neuroscience and anesthesia. Organon products are sold in over 100 countries, of which more than 60 have an Organon subsidiary. Organon is the human health care business unit of Akzo Nobel.
Organon |
| posted by Jennie Tate @ 3:40 AM |
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| Thursday, May 04, 2006 |
| Just Like Men, Women Need To Check Their Hearts |
Cardiologist Dr. Erica Jones reminds readers that heart disease among women has been growing and a woman's risk of developing heart disease or having a heart attack is now equal to that of a man. "The problem has been growing for years," says Dr. Jones. "But women have been slow to respond and get the preventative screenings and immediate medical help that can save their life. They need to."
Part of the problem, according to Dr. Jones, is that heart disease usually manifests itself a decade later in women - at 60 instead of 50 - when women's bodies are weaker and less able to fend off disease. Estrogen helps protect a women's heart, but after menopause things are different.
Symptoms can also problematic. While a man having a heart attack or heart problem may vomit, sweat profusely, or experience pressure like chest pain, women are more likely to feel subtle symptoms such as vague discomfort, fatigue, or nausea and attribute it to another cause.
About 35 percent of women ignore symptoms or don't report it to a physician, and those who go to an emergency room can wait longer for treatment as physicians rule out other causes. "Time is muscle," says Dr. Jones. "Get regular preventative screenings, and if even mild symptoms of a heart attack occur, seek medical attention immediately and make sure the physician considers it may be a heart attack. Waiting and seeing can be disastrous."
Dr. Jones is an associate professor of clinical medicine at Weill Cornell Medical College and an associate attending physician at the Iris Cantor Women's Health Center of NewYork-Presbyterian Hospital/Weill Cornell Medical Center.
Science Briefs
Science Briefs is an electronic newsletter published by the Office of Public Affairs that focuses on innovative medical research and patient care at Weill Cornell Medical College. |
| posted by Jennie Tate @ 10:44 AM |
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| Wednesday, May 03, 2006 |
| Children And Young Adults With Diabetes Do Not Meet Nutrition Recommendations |
Fewer than half of children and young adults who took part in a national multi-center study of young people with diabetes meet current dietary recommendations for many nutrients, potentially making treatment and management of their diabetes much more difficult, according to researchers at the University of South Carolina and other institutions.
The researchers analyzed at the nutrient intakes of nearly 1,700 10-to-22-year-olds who took part in the five-year nationwide SEARCH for Diabetes in Youth study. SEARCH is a multi-center study funded by the Centers for Disease Control and Prevention and the National Institute of Diabetes and Digestive and Kidney Diseases, focusing on children in the United States who have diabetes. Participants in the study had either Type 1 or Type 2 diabetes for at least 12 months.
The researchers found that less than half the participants met current dietary recommendations for total fat, vitamin E, fiber, fruits, vegetables and grains, "although a majority met recommendations for vitamin C, calcium and iron."
The researchers note that dietary recommendations for youth with diabetes "are based on strong scientific evidence regarding intake of specific nutrients and foods in relation to physiologic health outcomes, including appropriate growth and development through adolescent years and optimizing metabolic status…. Further work to better understand the barriers to healthful dietary habits and to identify effective approaches to improving dietary intake in youth with diabetes is urgently needed."
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Source: May 2006 Journal of the American Dietetic Association
The Journal of the American Dietetic Association is the official research publication of the American Dietetic Association and is the premier peer-reviewed journal in the field of nutrition and dietetics.
With approximately 65,000 members, the American Dietetic Association is the nation's largest organization of food and nutrition professionals. The Chicago-based ADA serves the public by promoting optimal nutrition, health and well-being. To locate a registered dietitian in your area, visit the American Dietetic Association at http://www.eatright.org/.
Contact: Julia Dombrowski
American Dietetic Association |
| posted by Jennie Tate @ 11:04 AM |
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