Hormone Replacement Therapy Is Linked to More Aggressive Breast Cancer
It was demonstrated in the initial analysis of the Women’s Health Initiative Study that women who were treated with estrogen and progestin had an elevated risk to develop breast cancer. This recent analysis has further demonstrated that these cancers are also more likely to be more advanced at the time of diagnosis.
Estrogen Therapy Accelerates Ovarian Cancer Growth
Researchers from the University of Colorado have demonstrated that estrogen can cause some types of ovarian cancer to grow faster in mouse models. About 60% of ovarian cancers will have estrogen receptors, and estrogen can cause these cancers to grow faster in these animal models.
Soy based Supplement, Natural S-equol, Can Reduce Hot Flashes, and Muscle and Joint Pain in First Study of US Women
This information was recently presented in poster form at the North American Menopause Society. S-equol is a whole soy germ –based supplement. It was recently shown to decrease the frequency of moderate to severe hot flashes and reduces menopausal associated muscle and joint pain. S-equol [7-hydroxy-3-(4'-hydroxyphenyl)-chroman] is a compound resulting — when certain bacteria are present in the digestive tract — from the natural metabolism, or conversion, of daidzein, an isoflavone found in whole soybeans. However, not everyone who consumes soy can produce s-equol. S-equol selectively binds to the estrogen receptor, most strongly to the receptor beta. Additional clinical evidence has also demonstrated that S-equol can help preserve bone.
Manufacturing Plan for Hot Flash Drug Candidate Menerba Approved by the FDA
Menerba is an oral, botanically derived drug candidate designed to treat hot flashes associated with menopause. Its action is through the estrogen receptor beta. The designs for the definitive studies are currently being planned with the FDA and the drug’s manufacturer, Bionovo.
The National Institute of Health is Increasing Funding to Study the Health Effects of Botanical Estrogens
The Botanical Research Center based at the University of Illinois, will receive a large portion of the funding, as well as University of Mississippi, Oregon State University and the FDA’s National Center for Toxicological Research. The research will utilize the expertise of a multidisciplinary team of researchers to address the many unknowns associated with use of botanical estrogens. Examples of naturally derived phyto estrogens are from soy, licorice root, wild yam and dong quai, Prior research related to the efficacy of the naturally derived estrogens has lead to mixed results. Some research has even demonstrated that some of these agents may interfere with breast cancer treatment and induce cognitive problems.
Non-Hormone Treatments of Hot Flashes
A new Cochrane review finds that a variety of non-hormonal treatments (mostly non-hormonal drugs) can offer women who have had breast cancer some relief from hot flashes. Relaxation therapy, the anti hypertensive Clonidine, the anti convulsant gabapentin and the anti depressants that inhibit serotonin reuptake were found in review to have a mild to moderate effect.
Menopause Associated Depression Can be Treated with an Antidepressant
Pristiq was recently demonstrated to be effective in treating menopause associated depression in the Journal of Clinical Psychiatry. . This data was recently published study generated from Virginia Commonwealth University. This is the first study to demonstrate the effectiveness of an antidepressant specifically related to perimenopause and post menopause.
Progestin Type May Alter Breast Cancer Risk in Hormone Replacement Therapy
In animal studies recently published in Cancer Prevention Research from the University of Missouri, researches compared synthetic progestins (medroxyprogesterone acetate – MPA), norgesterel, norethindrone, and megesterol acetate. Animal studies have demonstrated that MPA is a tumor promoter, however norgesterel and norethindrone are tumor inhibitors.
Posted: November 1st, 2010 | Author: drpoynor | Filed under: estrogen, general health, gynecology, menopause | Tags: news, reviews | No Comments »
Pain Management Of Endometriosis: Conservative Approach Is First-Line Treatment
Source: Medical News Today June 23, 2010
Ob-gyns recommend conservative nonsurgical treatment approaches for treating women with endometriosis-associated pain followed by more invasive procedures if these fail to alleviate pain, according to a newly updated Practice Bulletin published in the July issue of The American College of Obstetricians and Gynecologists’ journal, Obstetrics & Gynecology. The Practice Bulletin “Management of Endometriosis” includes the latest recommendations on the incidence, diagnosis, and treatment of this common gynecologic health condition.
Endometriosis is a chronic condition in which endometrial tissue that lines the inside of the uterus migrates outside of the uterus and attaches to the lining of the abdominal cavity and to internal organs inside the pelvis, including the ovaries, fallopian tubes, bladder, and bowel. The condition occurs in 6-10% of reproductive-age women. Endometriosis is a leading cause of chronic pelvic pain and a common cause of infertility, the two main symptoms. Some women with endometriosis have no symptoms, but for those that do, pain can range from mild to severe.
“We recommend starting with conservative approaches to treating women with endometriosis-associated pain,” says Tommaso Falcone, MD, who led the document update. “For instance, continuous oral contraceptives and nonsteroidal anti-inflammatory drugs are effective. If these fail and further medical management is needed, then gonadotropin-releasing hormone agonists or progestins can help by suppressing the disease.” Medical therapy, however, will not improve fertility for women trying to get pregnant since most of these drugs suppress ovulation. Medical therapy is effective while using it, but recurrence of pain symptoms is common after discontinuing the drugs. Surgery to remove endometriosis tissue helps improve pregnancy rates among infertile women, but it is difficult to predict by how much, said Dr. Falcone.
According to the College vaginal ultrasound is the best way to investigate the presence of endometriosis. The only definitive way to diagnose endometriosis is with laparoscopic surgery. Laparoscopy also can remove visible endometriosis lesions, but it is not 100% effective in helping pain. As with medical therapy, there is a high recurrence of symptoms in patients after laparoscopic surgery. Both laparoscopic surgery and long-term hormone suppression-typically with an oral contraceptive-will likely be needed to control pain.
The treatment of last resort for women with severe endometriosis is hysterectomy. “If a woman has completed having children and all other conservative treatments haven’t worked to stop the pain, she may consider having her uterus removed,” said Dr. Falcone. “If both ovaries are normal and all of the visible endometriosis is removed, then consideration should be given to conserving them.” This way, Dr. Falcone noted, women won’t suffer the consequences of a surgical menopause.
Even when both ovaries are removed, endometriosis symptoms can recur in some women, likely due to lesions that remain attached to the bowel. The Practice Bulletin notes that estrogen therapy after ovary removal does not appear to affect the risk of recurrence of endometriosis and can be safely considered to avoid an immediate surgical menopause.
Practice Bulletin #114, “Management of Endometriosis,” is published in the July 2010 issue of Obstetrics & Gynecology.
American College of Obstetricians and Gynecologists
Abbott And Neurocrine Announce Global Agreement To Develop And Commercialize Elagolix For The Treatment Of Endometriosis
Source: Medical News Today June 17, 2010
Abbott and Neurocrine Biosciences, Inc. announced they have entered into a collaboration agreement to develop and commercialize elagolix for the treatment of endometriosis-related pain. Elagolix is a novel, first-in-class oral gonadotropin-releasing hormone (GnRH) antagonist, which has recently completed a phase IIb study in endometriosis. In addition to endometriosis, elagolix will be evaluated for the treatment of uterine fibroids.
“Extensive preclinical and clinical experience with elagolix suggests this drug could be an important advance for women with endometriosis and uterine fibroids, highly prevalent conditions where there is a need for new treatments,” said John Leonard, M.D., senior vice president, pharmaceuticals, research and development, Abbott. “This agreement enhances Abbott’s late stage pipeline, with the potential for additional compounds in earlier stage development.”
Under the terms of the agreement, Abbott will receive worldwide exclusive rights to develop and commercialize elagolix and all next-generation GnRH antagonists for women’s and men’s health. Abbott will make an upfront payment of $75 million and will fund all ongoing development activities. Neurocrine is eligible to receive additional milestone payments of approximately $500 million from Abbott for the achievement of certain development, regulatory and commercial milestones; funding for certain internal collaboration expenses; plus royalty payments on any future product sales.
“We are pleased to have one of the world’s most admired companies as our partner in developing our entire GnRH portfolio for both women’s and men’s health indications,” said Kevin Gorman, president and chief executive officer, Neurocrine Biosciences. “Abbott shares our long-term vision for elagolix, and, together, we look forward to bringing this important new treatment option to endometriosis and uterine fibroid sufferers.”
About GnRH and Elagolix
Elagolix inhibits gonadatropin releasing hormone (GnRH) receptors in the pituitary gland and ultimately reduces circulating sex hormone levels. Elagolix has a unique profile that allows partial estrogen suppression. It maintains estradiol in the low-normal range, providing symptom reduction while avoiding significant bone loss or other adverse effects that can sometimes be associated with excessive suppression of estrogen. In Phase II studies, elagolix has been found to be effective in reducing the pain associated with endometriosis. To date, elagolix has been studied in 18 clinical trials totaling more than 1,000 subjects.
About Endometriosis and Uterine Fibroids
Endometriosis is associated with a multitude of symptoms, some of the most common of which include pain related both to menstruation (dysmenorrhea) as well as chronic pelvic pain throughout the menstrual cycle, and infertility. The World Endometriosis Research Foundation estimates that there are approximately 100 million women worldwide who suffer from endometriosis. With annual healthcare costs and endometriosis-related productivity losses of approximately $4,000 per patient, the annual direct and indirect costs of endometriosis are estimated to exceed $20 billion in the United States alone.
Uterine fibroids are benign tumors that form on the wall of the uterus. They are the most common type of growth found in a woman’s pelvis and are most common in women aged 30-40 years. While many women do not have symptoms, depending on the size, location and number, uterine fibroids can cause heavy menstrual bleeding, can put pressure on the bladder and rectum, and can cause pain and nausea. Symptoms can also include miscarriages and infertility. Depending on the symptoms, treatment sometimes requires surgery.
Source: Abbott LaboratoriesNeurocrine Biosciences
BioSante Pharmaceuticals Reports Positive LibiGel(R) Safety Data In Phase III Clinical Program
Source: Medical News Today June 23, 2010
BioSante Pharmaceuticals, Inc. (NASDAQ:BPAX), announced that the independent Data Monitoring Committee (DMC) of the ongoing LibiGel® Cardiovascular (CV) and Breast Cancer Safety Study unanimously recommended study continuation without modifications, after its third review of the study’s unblinded safety data. The review was based on data from almost 1,500 women-years of exposure. LibiGel is in development for the treatment of female sexual dysfunction (FSD), specifically, hypoactive sexual desire disorder (HSDD) in menopausal women, for which there is currently no FDA approved product. BioSante anticipates the submission of a new drug application (NDA) for LibiGel in 2011.
“To date, there have been only seven adjudicated CV events and only four diagnoses of breast cancer reported in the study population,” said Michael Snabes, M.D., Ph.D., BioSante’s vice president of clinical development. “If testosterone increased CV disease, the CV event rate would be expected to be higher in the women enrolled since as per the protocol, the study subjects are at the higher end of cardiovascular risk for the intended treatment population. With this favorable DMC recommendation, we believe that LibiGel will be the first product approved by the FDA to treat HSDD in menopausal women, also referred to as FSD.”
The LibiGel Phase III Cardiovascular and Breast Cancer Safety Study is a randomized, double-blind, placebo-controlled, multi-center, CV events and breast cancer study that will enroll between 2,500 and 4,000 women, exposed to LibiGel or placebo for 12 months. After NDA submission and potential approval of LibiGel, BioSante will continue to follow the women enrolled in the study for an additional four years. The first decision point as to whether enrollment is complete or needs to continue will occur early in the fourth quarter 2010.
The LibiGel safety study is tracking a predefined list of CV events, in agreement with the FDA, including CV death, myocardial infarction and stroke, in women 50 years of age or older and suffering from at least two CV risk factors including hypertension and diabetes. The objective of the safety study is to show the relative safety of testosterone compared to placebo in the number of CV events. The incidence of breast cancer also will be tracked over the course of the study.
About LibiGel
LibiGel® is a testosterone gel Phase III in clinical development for the treatment of women who suffer from female sexual dysfunction (FSD). The on-going Phase III efficacy trials are double-blind, placebo-controlled trials that will enroll up to approximately 500 surgically menopausal women each for a six-month clinical trial. The efficacy trials are being conducted under an FDA-approved special protocol assessment (SPA) agreement. LibiGel is absorbed quickly through the skin after a once-daily pea-sized application on the upper arm, delivering testosterone to the bloodstream evenly over time and in a non-invasive and painless manner.
In a Phase II trial, LibiGel significantly increased the number of satisfying sexual events in surgically menopausal women suffering from FSD by 238 percent versus baseline (p<0.0001); this increase also was significant versus placebo (p<0.05). In this study, the effective dose of LibiGel produced testosterone blood levels within the normal range for pre-menopausal women and had a safety profile similar to that observed in the placebo group. In addition, no serious adverse events and no discontinuations due to adverse events occurred in any subject receiving LibiGel. The Phase II clinical trial was a double-blind, placebo-controlled trial, conducted in the United States, in surgically menopausal women distressed by their low sexual desire and activity.
Source: BioSante Pharmaceuticals, Inc
Advisory Panel Says FDA Should Not Approve Drug To Address Female Sexual Dysfunction
Source: Medical News Today June 22, 2101
On Friday, an FDA advisory panel voted 11-0 against recommending FDA approval of a proposed treatment for hypoactive sexual-desire disorder, which decreases women’s sex drive, the Wall Street Journal reports.
The Reproductive Health Drugs Advisory Committee reviewed an application seeking FDA approval of the drug flibanserin, also known as the “pink pill” or “female Viagra.” Although the agency is not required to follow the panel’s recommendation, it typically does (Corbett Dooren, Wall Street Journal, 6/18).
The drug’s effects on women’s sexual drive was “not robust enough to justify the risks,” which included dizziness, fatigue and nausea, particularly with long-term daily use, according to Julia Johnson, chair of the advisory panel and head of the department of obstetrics and gynecology at the University of Massachusetts Medical School. She added that the drugmaker — Germany-based Boehringer Ingelheim — should continue to pursue research on the drug (Wilson, New York Times, 6/18).
According to the Journal, the panel’s recommendation “wasn’t surprising” because FDA released a background document last week with a “fairly negative review” of the drug. The company submitted data involving about 2,400 women for about six months treated with either flibanserin or a placebo months. FDA scientists said the drug did not show an increase in the women’s libido, although some women reported an increase in their number of sexually satisfying events. The document noted that it was “not clear whether the safety and efficacy data from these trials are generalizable to the target population for this drug.”
Boehringer said that women with HSDD have “extremely limited” treatment options and that flibanserin provided “clinically relevant” data for the drug’s efficacy (Wall Street Journal, 6/18). Christopher Corsico, the company’s U.S. medical director, said in a statement that the company is “disappointed with the advisory committee’s recommendation and will work with the FDA to address questions raised” (New York Times, 6/18).
Drug Marketing ‘Bigger Issue’ in Flibanserin Review, Los Angeles Times Editorial Say
Early Menopause Linked To Higher Risk Of Future Cardiovascular Disease
Source: Medical News Today June 22, 2010
Women who experience early menopause appear to have more than twice the risk of having a heart attack, stroke or other cardiovascular disease event later in life than do women who do not go through early menopause, a new study indicates. The results will be presented Saturday at The Endocrine Society’s 92nd Annual Meeting in San Diego.
Early menopause was defined as going through menopause before age 46, either naturally or surgically through removal of both ovaries.
“It is important for women to know that early menopause is a potential risk factor for cardiovascular disease the number one killer of American women. They can then work harder to improve their modifiable risk factors, such as high cholesterol and blood pressure, by exercising and following a healthy diet,” said the study’s principal author, Melissa Wellons, MD. She is a fellow at the University of Alabama, Birmingham.
Previous research found a link between early menopause and cardiovascular disease in mostly white and European populations, according to Wellons, but the new study had a multiethnic representation of women. Of the more than 2,500 participants, about 40 percent were white, 25 percent were black, 22 percent were Hispanic and 13 percent were Chinese-American.
At the beginning of the study in July 2000, women were ages 45 to 84. Nearly 28 percent of the women reported early menopause; 446 women had natural menopause and 247 had surgical menopause. Women not yet past menopause were included in the group that did not have early menopause. Follow-up tracked whether participants had a cardiovascular disease event, which included a heart attack, nonfatal cardiac arrest (a suddenly stopped heart), angina (chest pain due to narrowed or blocked arteries), probable angina followed by angioplasty or bypass surgery, a stroke or death due to stroke, heart attack or other cardiovascular disease.
No one had any such event before age 55. After that, women who had early menopause were more likely to have had a cardiovascular disease event than women who had not gone through menopause before age 46.
Even when the researchers’ statistical analysis controlled for current or previous use of hormone replacement therapy or for major cardiovascular risk factors, it did not change the results. Early menopause remained a risk factor on its own, although it is unclear why, Wellons reported.
“Our study is observational; therefore, we cannot conclude that early menopause somehow causes future cardiovascular disease,” Wellons said. “However, our findings do support the possible use of age at menopause as a marker of future heart and vascular disease risk.”
The women in this study were part of the Multi-Ethnic Study of Atherosclerosis (MESA), an observational research study funded by the National Institutes of Health and involving more than 6,000 men and women from six U.S. communities. Also contributing to the current study were researchers from Johns Hopkins Medicine, Baltimore; Wake Forest University, Winston-Salem, N.C.; and the University of Minnesota, Minneapolis.
Source: Endocrine Society
Progesterone Is Effective For Hot Flash Treatment And Provides An Alternative To Estrogen
Source: Medical News Today June 22, 2010
Postmenopausal women who experience bothersome hot flashes or night sweats may have an alternative treatment to estrogen. According to a new study, oral micronized progesterone relieves those symptoms. The results will be presented Saturday at The Endocrine Society’s 92nd Annual Meeting in San Diego.
“This is the first evidence that oral micronized progesterone, which is molecularly identical to the natural hormone, is effective for women with symptomatic hot flashes,” said the presenting author, Jerilynn Prior, MD, professor, University of British Columbia, Vancouver, Canada.
Available only by prescription and sold under the brand name Prometrium in the United States and Canada, this form of progesterone is manufactured from a steroid in yams.
“Vasomotor symptoms” hot flashes (sometimes called hot flushes) and night sweats are experienced by most women during the years around the final menstrual period. In the most symptomatic women (at least 5-10%) these symptoms disturb sleep, energy and quality of life, Prior said.
The researchers recruited 114 healthy postmenopausal women seeking hormonal therapy for hot flashes and night sweats and randomly assigned them to take either oral micronized progesterone or an inactive substance (placebo), both as three round capsules at bedtime. Neither the women nor the study team members were aware which treatment the study participants received during the three months of therapy. The time since their last menstrual flow was one to 10 years, with an average of four years. To be eligible to participate in the study, women could not have taken ovarian hormone therapy within the past six months.
Prior and Christine Hitchcock, PhD, of the University of British Columbia, calculated the average daily vasomotor symptom score, or VMSScore, from the data that subjects recorded in a daily diary. This score reflects both intensity and number for hot flashes and night sweats each day.
Progesterone, in a 300-milligram dose, was more effective than placebo at decreasing the intensity and number of symptoms, the authors reported, and the difference was both statistically significant and clinically important. The 68 women taking progesterone showed a 56% improvement from baseline in VMSScore, and a 48% reduction in the number of VMS; the 46 women taking placebo had 28% lower VMSScores and a 22% reduction in number.
“Women improve very quickly on oral micronized progesterone. The improvement is apparent within the first 4 weeks,” Prior said.
Micronized progesterone did not cause any serious side effects, she said. The drug may be an option for postmenopausal women who do not want to or should not take estrogen “currently the only effective therapy for decreasing severe vasomotor symptoms,” Prior said.
Besins Healthcare and Schering Canada donated the progesterone and placebo for this study.
Source: Endocrine Society
For Insulin-Resistant Women, Cutting Carbs Is More Effective Than Low-Fat Diet
Source: Medical News Today June 21, 2010
Obese women with insulin resistance lose more weight after three months on a lower-carbohydrate diet than on a traditional low-fat diet with the same number of calories, according to a new study. The results were presented at The Endocrine Society’s 92nd Annual Meeting in San Diego.
“The typical diet that physicians recommend for weight loss is a low-fat diet,” said the study’s lead author, Raymond Plodkowski, MD, chief of endocrinology, nutrition and metabolism at the University of Nevada School of Medicine, Reno. “However, as this study shows, not all people have the same response to diets.”
People with insulin resistance, a common precursor for Type 2 diabetes, metabolize carbohydrates, or “carbs,” abnormally, which may affect their rate of weight loss. For them, Plodkowski said, “the lower-carb diet is more effective, at least in the short term.”
At 12-weeks, the study funded by Jenny Craig and using prepared calorie-controlled meals as part of a behavioral weight loss program, found that the insulin resistant women on a lower-carb diet lost 3.4 pounds more than those on a low-fat diet.
Forty-five obese women between the ages of 18 and 65 years participated in the study, and all had insulin resistance, as found by fasting blood levels of insulin. The researchers randomly assigned the women to either a low-fat or lower-carb diet. The groups did not differ significantly in average body weight, the authors reported. On average, women in the low-fat diet group weighed 213 pounds, while women in the other group weighed 223 pounds.
The composition of the low-fat diet was 60 percent of calories from carbs, 20 percent from fat and 20 percent from protein. Although the lower-carb diet also had 20 percent of calories from protein, it had 45 percent from carbs and 35 percent from primarily unsaturated fats, such as nuts. Menus included a minimum of 2 fruits and 3 vegetable servings a day.
Use of prepared meals helped make the structured diets easier and more palatable for the dieters, according to Plodkowski. “We wanted to make this study real-world – anyone could follow this plan by making moderate changes as part of a healthy menu,” he said.
Both groups lost weight at each monthly weigh-in, but by 12 weeks, the insulin resistant group receiving the lower-carb diet lost significantly more weight, 19.6 pounds versus 16.2 pounds in the low-fat diet group – approximately 21 percent more on average.
“These data have potential widespread applications for clinicians when counseling people with insulin resistance to help improve weight loss as part of a calorie-restricted diet,” Plodkowski said. “They should at least initially lower their carbohydrate intake.”
Source: The Endocrine Society
Posted: June 25th, 2010 | Author: drpoynor | Filed under: endometriosis, gynecology, menopause, nutrition & diet, sex, weight loss | Tags: cardiovascular, diet, endometriosis, home, hot flashes, libido, menopause, news, nutrition | 3 Comments »
For a number of years now scientists have been studying the effects of the so called Mediterranean diet, and it all looks good. The diet is called the Mediterranean diet because it mimics the eating and lifestyle patterns of the residents of the Mediterranean costal region. The diet and lifestyle emphasize eating primarily plant based foods such as fruits and vegetables, whole grains, legumes and nuts, replacing butter with healthy fats such as olive oil and canola oil, using herbs and spices to flavor food instead of salt, eating fish and poultry at least two times a week, limiting red meat intake to no more than a few times a month, getting plenty of exercise, and drinking red wine in moderation (optional). The diet and lifestyle have been demonstrated to be associated with healthy weight loss, lower blood pressure and cholesterol levels, a reduction in the risk of diabetes and heart disease, as well as associated with lower risks of cancer. Most recently new study has demonstrated that brain function is improved with this diet and lifestyle. For more information on the Mediterranean diet and what it can do for you go to: The Mediterranean Diet 
