Notice of Decision for Pr VISANNE® Canada

Notice of Decision for PrVISANNE®Help on accessing alternative formats, such as Portable Document Format (PDF), Microsoft Word and PowerPoint (PPT) files, can be obtained in the alternate format help section.

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Contact: Bureau of Metabolism, Oncology and Reproductive Sciences

Date issued: November 7, 2011

On October 12, 2011, Health Canada issued a Notice of Compliance to Bayer Inc. for the drug product, Visanne.

Visanne contains the medicinal ingredient dienogest which is a progestin.

Visanne is indicated for the management of pelvic pain associated with endometriosis. The efficacy of Visanne has not been tested beyond 15 months.

Endometriosis is a gynaecological disease where endometrial tissue is found outside the uterine cavity, most commonly on the ovaries and the peritoneal surface. This tissue can cause inflammation and adhesions which result in chronic pelvic pain and often infertility. The cause of endometriosis remains unknown. Visanne reduces the endogenous production of estradiol and thereby suppresses the trophic effects of estradiol on both the eutopic and ectopic endometrium. When given continously, Visanne leads to a hyperprogestogenic and moderately hypoestrogenic endocrine environment causing initial decidualization of endometrial tissue. In addition to the estradiol-mediated effects Visanne also has direct antiproliferative, immunologic and antiangiogenic effects that contribute to the reduction of pelvic pain associated with endometriosis.

The market authorization was based on quality, non-clinical, and clinical information submitted. The efficacy and safety of Visanne were demonstrated primarily in three multicentre Phase III studies. All three studies enrolled patients with a confirmed diagnosis of endometriosis with various stages of disease severity. Assessment of pelvic pain associated with endometriosis was determined by using a visual analog scale (0-100 mm, where 0 mm represents no pain and 100 mm represents severe pain). The first study was a double-blind placebo-controlled study where 102 patients were treated orally (PO) with a Visanne 2 mg tablet once daily (OD) compared to 96 patients who were treated with a placebo, over a 12 week period. The second study was an open-label extension to the placebo-controlled study. The extension study included 168 women; 87 previously treated with Visanne (2 mg, PO, OD) and 81 previously treated with placebo. All 168 women received Visanne (2 mg, PO, OD) for an additional 52 weeks to assess the long-term efficacy of Visanne treatment. The third study compared Visanne (2 mg, PO, OD) to 3.75 mg leuprolide acetate administered intramuscularly every four weeks, where 120 patients received Visanne treatment and 128 patients received leuprolide acetate, for a 24-week treatment period. Results from all three studies demonstrated that treatment with Visanne produced clinically significant reductions in pelvic pain compared to baseline values. In the placebo-controlled study, following 12 weeks of treatment with Visanne, the mean reduction of pelvic pain compared to baseline was 27.4 ± 22.9 mm. The open-label extension study showed continued improvement in pelvic pain for up to 15 months. In the third active comparator study, Visanne demonstrated efficacy similar to leuprolide acetate in reducing pelvic pain associated with endometriosis. In all clinical studies, Visanne was generally well-tolerated.

Visanne (2 mg, dienogest) is provided in tablet form. The recommended dose of Visanne is one oral tablet per day, preferably taken at the same time each day, with some liquid as needed. Visanne tablets are intended for continuous administration regardless of any vaginal bleeding. Dosing guidelines are available in the Product Monograph.

Visanne is contraindicated in women with any of the conditions listed below, which are partially derived from information on other progestin-only preparations. Should any of the conditions appear during the use of Visanne, treatment must be discontinued immediately.

•Known or suspected pregnancy;
•Lactation;
•Active venous thromboembolic disorder;
•Arterial and cardiovascular disease, past or present [for example (e.g.) myocardial infarction, cerebrovascular accident, ischaemic heart disease];
•Diabetes mellitus with vascular involvement;
•Presence or history of severe hepatic disease as long as liver function values have not returned to normal;
•Presence or history of liver tumours (benign or malignant);
•Known or suspected sex hormone-dependent malignancies;
•Undiagnosed abnormal vaginal bleeding;
•Any ocular lesion arising from ophthalmic vascular disease, such as partial or complete loss of vision or defect in visual fields;
•Current or history of migraine with focal aura;
•Hypersensitivity to dienogest or to any ingredient in the formulation or component of the container.
Visanne should be administered under the conditions stated in the Product Monograph taking into consideration the potential risks associated with the administration of this drug product. Detailed conditions for the use of Visanne are described in the Product Monograph.

Based on the Health Canada review of data on quality, safety, and efficacy, Health Canada considers that the benefit/risk profile of Visanne is favourable for the indication stated above.

© 2011, Bayer Inc.
®VISANNE is a trademark used under license by Bayer Inc.

Notices of Decision (NDs) are produced in accordance with the Summary Basis of Decision (SBD) initiative. All NDs will be reproduced within the corresponding SBD, normally available within 5 months of product authorization.

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/drug-med/nd_ad_2011_visanne_132174-eng.php

Visanne® is the first oral treatment approved in more than 10 years for Canadian women with endometriosis

MORE FINANCIALS November 29, 2011 7:00 AM - General
Save Visanne® is the first oral treatment approved in more than 10 years for Canadian women with endometriosis~ Provides women with the first approved long-term, oral treatment option to relieve debilitating pelvic pain from endometriosis ~

TORONTO, Nov. 29, 2011 /CNW/ - There is now relief for Canadian women living with the pelvic pain associated with endometriosis. The symptoms of endometriosis, including severe menstrual cramps, painful intercourse, painful urination or bowel movements, and lower back or abdominal pain, take a toll on a woman's emotional health and overall quality of life. Bayer HealthCare announced that Visanne® (2 mg dienogest tablets) was approved by Health Canada for the management of pelvic pain associated with endometriosis. It is the first long-term, oral, progestin-only regimen specifically developed for women with endometriosis in more than 10 years.1

"Once diagnosed, endometriosis patients must use a treatment on a daily basis to cope with the immense pain of the disease," said Dr. Sony Singh, Director of Minimally Invasive Gynecology, Department of Obstetrics and Gynecology, University of Ottawa. "Visanne is an important management option for patients with the disease, as it is proven to relieve the chronic, debilitating pelvic pain caused by endometriosis including menstrual pain and pain during sexual intercourse. This is the first new treatment in more than a decade to help these women, which is encouraging."

Visanne® has been shown to provide effective pain relief in women with endometriosis, as clinical studies of up to 15 months duration, have proven that Visanne® is effective at relieving pelvic pain.2 Visanne® contains a novel progestin called dienogest, which suppresses the effects of estradiol on endometrial tissue and effectively reduces pelvic pain.3

The Impact of Endometriosis
Endometriosis is the growth of tissue, similar to the kind that lines the uterus every month, elsewhere in the abdomen. This excess tissue responds to the monthly menstrual cycle and when the tissue breaks down, it can lead to inflammation, causing pain. Common sites for endometrial growth are the ovaries, on the uterus and behind the uterus.4 The condition affects approximately 5 - 10 per cent of women of reproductive age.5 Pain associated with endometriosis can be excruciating and debilitating and is often the most difficult symptom for women with the disease.6

The disease can greatly impact a woman's social, professional and personal life, and women with endometriosis often experience a higher incidence of depression and emotional distress due to the uncertainty of diagnosis, unpredictability of symptoms and living a normal life.7

Recognize the Symptoms
Despite the high prevalence of endometriosis, there is a lack of general disease awareness and few women recognize the symptoms - thus causing a significant delay in diagnosis. Studies show it takes an average of three years from the time a woman has her first symptom to the time she discusses it with her doctor.8 It frequently takes up to 12 years for a woman to get a confirmed diagnosis from the first time she seeks help for her symptoms.9

"It is very common for women to live for several years with the severe pelvic pain of endometriosis before receiving an official diagnosis. This often means a delay in disease management consequently, negatively impacting their professional, social and psychological life," said Jan Silverman, The Endometriosis Network of Toronto (TENT). "It's important for women to learn about the symptoms of endometriosis, rather than just thinking pelvic pain is 'normal.' Women need to know that endometriosis is real and the pain can be treated, so it's important for them to speak with their doctors. The availability of a new treatment is good news and a step in the right direction."

The Facts on Visanne®
Visanne® (2 mg dienogest tablets) is indicated for the management of pelvic pain associated with endometriosis. Clinical trials regarding the efficacy of Visanne® have lasted up to 15 months.10

In clinical trials, Visanne® was generally well tolerated. The most frequent side effects reported were headache, breast discomfort including breast engorgement and breast pain. Undesirable effects, such as irregular bleeding, are more common during the first months of treatment with Visanne® and subside with continued treatment.2 Patients are encouraged to talk to their healthcare provider to see if Visanne® is right for them.

To learn more about endometriosis, visit www.endometriosisinfo.ca. For more information on endometriosis support groups from TENT, visit the group's Facebook page: http://www.facebook.com/group.php?v=info&ref=mf&gid=301016744454
.

About Bayer Inc.
Bayer Inc. (Bayer) is a Canadian subsidiary of Bayer AG, an international research-based group with core businesses in health care, crop science and innovative materials. Headquartered in Toronto, Ontario, Bayer Inc. operates the Bayer Group's HealthCare and MaterialScience businesses in Canada. Bayer CropScience Inc., headquartered in Calgary, Alberta operates as a separate legal entity in Canada. Together, the companies play a vital role in improving the quality of life for Canadians - producing products that fight diseases, protecting crops and animals, and developing high-performance materials for applications in numerous areas of daily life. Canadian Bayer facilities include the Toronto headquarters and offices in Montréal and Calgary.

Bayer Inc. has approximately 800 employees across Canada and had sales of $827 million CDN in 2010. Globally, the Bayer Group had sales of over 35 billion Euro in 2010. Bayer Inc. invested approximately $36 million CDN in research and development in 2010. Worldwide, the Bayer Group spent the equivalent of over 3.1 billion Euro in 2010 in R&D. For more information, go to www.bayer.ca.

Forward-Looking Statements
This news release may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer's public reports which are available on the Bayer website at http://www.bayer.com/
. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

References:
--------------------------------------------------------------------------------

1 Lupron Depot Canadian Product Monograph. http://www.abbott.ca/static/content/document/LUPRON-DEPOT-ENDO-PM-23MAR10.pdf.
 May 20, 2011.

2 Visanne Product Monograph. 2011. Page 21.

3 Visanne Product Monograph. 2011. Page 14.

4 SOGC.ca. What is Endometriosis? Available at http://www.sogc.org/health/health-endometriosis_e.asp
. Accessed November 1, 2011.

5 Endometriosis. Infertility Awareness Association of Canada. Available at: http://www.iaac.ca/content/endometriosis-1
. Accessed October 31, 2011.

6 Hummelshoj L. Medical needs in endometriosis. Gynaecology Forum 2010;15(2):5-7.

7 Kennedy S, Bergqvist A, Chapron C, D'Hooghe T, Dunselman G, Greb R, Hummelshoj L, Prentice A, Saridogan. ESHRE guideline on the diagnosis and management of endometriosis. Human Reproduction 2005;20(10):2698-2704. Also available online at: http://guidelines.endometriosis.org/.


8 Diagnosis: http://www.womenshealthmatters.com/centres/pelvic_health/endometriosis/diagnosis/index.html . Accessed November 1, 2011.

9 SOGC Diagnosis and Management Guidelines. Available at: http://www.sogc.org/guidelines/documents/gui244CPG1007E.pdf.  Accessed November 1, 2011.

10 Visanne Product Monograph. 2011. Page 3.



For further information:
For more information or to arrange an interview, please contact:

Laine Jaremey Tiana DiMichele
GCI Group (Canada) Bayer Inc.
416-486-7224 416-240-5466
laine.jaremey@gcicanada.com

http://www.newswire.ca/en/story/886139/visanne-is-the-first-oral-treatment-approved-in-more-than-10-years-for-canadian-women-with-endometriosis

Endometriosis

This patient education video explains endometriosis. Endometriosis is a common medical condition that affects women. The program covers anatomy, symptoms, causes, diagnosis, and treatment options.

Taking birth-control pills — but not for birth control

By Jennifer LaRue Huget
Oral contraceptives are quite the multi-taskers these days.

A new report finds that of the 11.2 million women ages 15 to 44 who use oral contraceptives, 86 percent do so primarily to prevent pregnancy, while the remaining 14 percent — 1.5 million women — take them solely for other reasons. Those reasons include easing menstrual cramps or pain, regulating menstrual cycles, relieving symptoms of endometriosis and controlling acne. The report further found that more than three quarters of a million women who take the pill report never having had sex.

The report was written and published by the nonprofit Guttmacher Institute (which works to “advance sexual and reproductive health and rights,” according to its Web site) and drawn from data collected through the federal National Survey of Family Growth.

The report could help clarify, or further muddy, the controversy over whether the federal government should require insurance companies to cover the cost of birth control, including oral contraceptives.

By Jennifer LaRue Huget | 07:00 AM ET, 11/18/2011

http://www.washingtonpost.com/blogs/the-checkup/post/taking-birth-control-pills--but-not-for-birth-control/2010/12/20/gIQAbKieVN_blog.html

'Top Chef' Host Padma Lakshmi On Dealing With Her Chronic Pain From Endometriosis

Padma Lakshmi, an author, model and Emmy-nominated host of Bravo's "Top Chef," suffered chronic pain every month for 23 years before she was finally diagnosed with endometriosis at age 36.

"I even had regular exams, and I had an ovarian cyst removed. They said everything would be better, but it didn't, and that was the tip of the iceberg," Lakshmi, now 41, said in an interview with HuffPost. "If I had been diagnosed at 20, or 25, the quality of my life would have been drastically different."

Endometriosis is actually quite common, affecting 8.5 million women in North America, though many are not diagnosed until their mid-20s, according to the Endometriosis Foundation of America, a non-profit organization Lakshmi co-founded with her doctor, Dr. Tamer Seckin, MD, to educate girls and young women about the condition. Just last month, the foundation held a conference to teach nurses about endometriosis, as they are often the first to see potential signs of the condition.

Undiagnosed and untreated, endometriosis causes abnormally painful cramping, bloating and nausea, and can even lead to infertility, according to the Mayo Clinic. It's often confused for ovarian cysts, pelvic inflammatory disease and irritable bowel syndrome. There is no cure for the condition, which occurs when the endometrium (the tissue that lines the inner part of the uterus) grows outside of the uterus, most commonly on the ovaries, bowel or the tissue that lines the pelvis, according to the Mayo Clinic. Depending on the pain, painkillers, hormone therapy, surgery and even hysterectomy are options for treating the condition.

Risk factors for the condition include having a shorter-than-normal menstrual cycle, having never given birth and having a family history (a mom, aunt or sisters) of the disease, the Mayo Clinic reported.

Lakshmi's in the family history camp. Her mother had undiagnosed endometriosis, and so when Lakshmi grew up experiencing the severe pain every month, she thought "it was just my lot in life."

Click here to read the rest: http://www.huffingtonpost.com/2011/11/15/padma-lakshmi-endometriosis-chronic-pain_n_1094003.htm l

Endometriosis slowly emerges as a debilitating Disease for Women

Endometriosis slowly emerges as a debilitating Disease for Women
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Written by Cleophas Mutinda




Imagine a pain in your abdomen so excruciating that you are unable to get out of bed for several days every month. That is horrible enough, but when it continues 12 times a year for more than 27 years, majority of people would agree it is cruel.

Most women with endometriosis will recognise this shocking scenario as not imaginary, but very real. They know the misery of pelvic pain and have poignant stories of how endometriosis has devastated their lives with terrible suffering. Many women feel angry or despondent about being robbed off a normal life during teenage, adulthood and even sometime a ruined motherhood.

Endometriosis is a gynaecological condition, which occurs when, cells like the ones (endometrial cells) lining inside of the uterus (womb) grow outside, usually on the surfaces of organs in pelvic and abdominal areas. It can be found within the peritoneal cavity, on the ovaries and the bowels or bladder. In extremely rare cases, endometriosis can be found in lungs or other parts of the body. Endometriosis can affect any menstruating woman, from time of her first period to menopause, regardless of race, ethnicity or socio-economic status. Endometriosis rarely persists after menopause. The disorder, for which there is no absolute cure, affects over 70 million women and girls worldwide. Often stigmatized as simply “painful periods,” Endometriosis is a puzzling and widely misunderstood illness.

It is not known exactly what causes endometriosis. But over the years several theories have been advanced to explain the probable cause of the disease although none can fully explain the various clinical manifestations of the disease. A theory proposed by John Sampson in the 1920s, suggests that endometriosis may result from something called “retrograde menstrual flow”, in which some of the tissue that a woman sheds during her period flows back through the tubes and grows in the pelvic cavity. While studies show that retrograde menstrual flow is a universal phenomenon among women of reproductive age, the theory fall short of explaining why the tissues survive in some women, but fail in others. Another theory proposed by Iwanoff in 1898, claims that, the transformation of what we call coelomic epithelium into endometrial-like tissue may be a cause of endometriosis. This theory has been supported by experimental data. The induction theory, proposes that an endogenous factor can induce peritoneal cells to develop into endometrial tissue. This theory has been supported by experiments in rabbits.



Lymphatic or vascular hypothesis suggests that endometrial fragments may be transported through blood vessels or the lymphatic system to other parts of the body. This theory speculates how endometriosis ends up in distant sites, such as the lung, brain, or the skin. A genetic linkage has been adduced which claims that, this disease could be inherited, or result from genetic errors, making some women more prone to develop the condition than others.



Studies show that the risk of endometriosis is seven times greater if the disease has affected a first-degree relative. This theory has been supported by experiments in mouse model but has not been verified either in women. Immunological etiology (cause) has also been conjured since studies report that many women with endometriosis exhibit immunological abnormalities. It is speculated that the immune system may fail to clear the menstrual debris in the pelvic cavity, allowing the endometrial cells to implant and develop into endometriosis.



Also most scientists agree that endometriosis is exacerbated by oestrogen; a hormone involved in the thickening of the endometrium and appears to promote the growth of disease implants. Some studies have pointed out environmental factors like toxins may contribute to the development of endometriosis, though this theory has not been confirmed and remains controversial.



The most common symptoms of endometriosis are abdominal pain and infertility. Some studies have reported that endometriosis may occur in 30%-40% of women with infertility and the incidence of endometriosis in women with pelvic pain may be higher than 50%.



Endometriosis associated pain may include but not limited to extremely painful (disabling) menstrual cramps, chronic pelvic pain (which includes lower back pain and pelvic pain), pain during or after sex, painful bowel movements or painful urination during menstrual periods, heavy menstrual periods and bleeding between periods. The amount of pain a women feels is sometimes not linked to degree of endometriosis. Some women have no pain even though their disease is extensive, while others have severe chronic pelvic pain even though they have only few affected areas.

The relation between endometriosis and pain is still shrouded in the mist of intricate puzzle and ignorance. Many women with endometriosis feel pain during their periods. Normally, a woman’s menstrual cycle involves her endometrial tissue to build up, breaks down into blood and tissue debris, and is shed as her menstrual flow or period. This cycle of growth and shedding happens every month under normal condition. Endometriosis grows outside the uterus and also goes through a similar cycle, build-up, breakdown and bleed every month. The problem is the tissue is in the wrong place and can’t leave the body the way a woman’s period normally does. Studies show that as part of this process, endometriosis may spur the production of substances that may irritate the nearby tissue, as well as provoke the release of chemicals that cause or mediate pain. Over time, endometriosis areas can grow and become nodules or bumps on the surface of pelvic organs, or become cysts (fluid-filled sacs) in the ovaries and may cause the organs in the pelvic area to adhere together.

Endometriosis is more than just simple "killer" cramps. Women and girls around the world continue to suffer in silence with a disease that can be potentially devastating to every aspect of their lives. It can be so painful as to render a woman or teenager unable to care for herself or her family, attend work, school, or social functions, or go about her normal routine. Endometriosis has a negative impact on the individual quality of life, affecting both physical and emotional well-being. A study by the American Endometriosis Association, demonstrated that 81% of the endometriosis patients in USA were unable to work, including household chores, because of pelvic pain. Approximately 27% were incapacitated for 3 or more days and 87% complained of fatigue or low energy. These figures are indicators of enormous suffering, in addition to the healthcare costs incurred. The need to develop intervention strategies is eminent, a published poll reveals women have to wait an average of 11.7 years in US and 8 years in UK to get a correct diagnosis after the initial onset of symptoms and a patient will seek the counsel of five or more physicians before her pain is adequately addressed and diagnosed. Once diagnosed, it is not unusual for a patient to undergo repeat surgeries and embark on many different medical therapies in an attempt to treat her symptoms. Endometriosis is a bit puzzling. We do not know why it causes such extreme symptoms in some women, while less in others. The treatment options can sometimes be unsuccessful. Sadly, endometriosis is associated with menstruation, sex, infertility, and pain (taboos in many societies), thus it is a disease that is not well known, understood, or accepted in the general public. This is frustrating for those who suffer from endometriosis, and for those who care for someone with the disease.

There is no non-invasive test to diagnose endometriosis. In fact, the only gold standard diagnosis of endometriosis is a surgical procedure known as laparoscopy and confirm histologically by taking a biopsy of the suspicious tissue.

However, this is an expensive, minimally invasive procedure. Furthermore, a specialised surgeon is needed for adequate assessment of the pelvis, for recognition of the various types and appearances of the disease. If the patients decline surgery, this makes diagnosis a challenge, and therefore an experienced gynaecologist should be able to recognise symptoms suggestive of endometriosis. The fact that there is no non-invasive diagnostic test for endometriosis is frustrating for clinicians as well as for women with the disease and underscores the need for search of better diagnostic tools.

Since the cause of endometriosis remains unknown, a treatment that fully cures the disease is yet to be developed. Choosing a holistic, treatment option comes down to the individual woman's needs, depending on symptoms, age, and reproductive desires.

Pain is the most common symptom in many women with endometriosis, mainly managed by painkillers, which may vary from simple analgesics to non-steroidal anti-inflammatory drugs. Most researchers agree that endometriosis is exacerbated by oestrogen. Subsequently, hormonal treatments for endometriosis attempt to reverse oestrogen production in a woman's body and thereby alleviate symptoms. However, hormonal therapies have varying degrees of side effects, and unfortunately, whatever pain relief is achieved tends to be only temporary for many women. Most gynaecologists agree that laparoscopic surgery is the only way to diagnose and treat endometriosis. Laparoscopy involves a small cut or incision in the abdomen, inflating the abdomen with harmless gas, and then inserts a viewing instrument with help of light (Laparoscope) into the abdomen. The success of surgery depends largely on the skills of the surgeon and the thoroughness of the surgery. The aim is to remove all endometriosis lesions, cysts, and adhesions. Today, most endometriosis surgery is being done through the laparoscopy, although a full abdominal incision called a laparotomy may still be required in rare cases for extensive disease or bowel resections.

Although the prevalence of endometriosis is well documented in women living in the developed world, studies among African women are still limited. The current myth is that endometriosis rarely affects women of African origin. However, among African-American women in the USA, studies have shown endometriosis is one of the common indications for major gynaecological surgery and hysterectomy, and is associated with a high hospital costs. Although genetically, African-American and African women from the African continent are not necessarily identical given the known genetic admixture among the African-American population. Lack of awareness of endometriosis as a potentially disabling disease and poor access to state-of art diagnostic and therapeutic facilities has contributed to the meagre data on prevalence of the disease in the African population. There is need to initiate awareness campaign of endometriosis to reach all women in Africa. Also to highlight the general lack of information, facilitate endometriosis research efforts and draw attention to the impact and implications of the disease to healthcare systems in our country and the continent in general.

The writer is a Senior Scientist with special interest in endometriosis and ovarian cancer research

http://www.africasciencenews.org/en/index.php/health/63-health/194-endometriosis-slowly-emerges-as-a-life-threatening-disease-for-women

sharing my experience with the robotic laparoscopy and endometriosis

http://www.youtube.com/watch?v=lTCMy4k9qrE&feature=related 

Oxytocin receptor expression in smooth muscle cells of peritoneal endometriotic lesions and ovarian endometriotic cysts.

Oxytocin receptor expression in smooth muscle cells of peritoneal endometriotic lesions and ovarian endometriotic cysts.
Authors
Mechsner S, Bartley J, Loddenkemper C, et al.
Institution
Endometriosis Research Center Berlin, Department of Gynecology, Charité, Campus Benjamin Franklin, Hindenburgdamm 30, 12200 Berlin, Germany.

Source
Fertil Steril 2005 Apr.:1220-31.
Abstract
To investigate the expression of oxytocin receptor (OTR) in peritoneal and ovarian endometriotic lesions.Retrospective nonrandomized study.University hospital endometriosis research center.Premenopausal women with histologically confirmed endometriosis were selected. Peritoneal endometriotic lesions (n = 120); ovarian endometriotic cysts (n = 40); peritoneal biopsies, distant from the endometriotic lesion (n = 55); and unaffected peritoneal biopsies from patients without endometriosis (n = 11) were obtained. Hysterectomy specimens from patients without endometriosis and/or adenomyosis were used for controls (n = 10).Histopathological examination of peritoneal and ovarian specimens for OTR expression and identification of smooth muscle cells by immunohistochemistry staining with antibodies against OTR and smooth muscle actin. In addition, Western blot analysis, double-immunofluorescence, and in vitro studies with primary cell cultures have been performed.Comparison of the immunoreactive score of the OTR and smooth muscle actin expression with the smooth muscle content in peritoneum with and without endometriosis.In the epithelial cells of endometriotic lesions, we could demonstrate a high OTR expression. The stromal cells were OTR negative with the exception of some single cells. By using a monoclonal anti-smooth muscle actin antibody, these cells could be identified as intrastromal OTR-positive smooth muscle cells. The peritoneum of women with endometriosis shows a significantly higher smooth muscle content than the peritoneum of women without endometriosis. There were no significant differences between the smooth muscle content of active or inactive lesions and the stage of disease.Oxytocin receptor is expressed in smooth muscle cells and epithelial cells of peritoneal endometriotic lesions and ovarian endometriotic cysts. The inhibition of OTR by specific inhibitors might be a useful approach for the treatment of endometriosis-associated pain.

Mesh
Adult
Blotting, Western
Endometrium
Female
Fluorescent Antibody Technique
Humans
Metaplasia
Middle Aged
Myocytes, Smooth Muscle
Myometrium
Ovarian Cysts
Peritoneum
Receptors, Oxytocin

Language
eng

Pub Type(s)
Journal Article Research Support, Non-U.S. Gov't

PubMed ID
15831296
http://www.unboundmedicine.com/anesthesia/ub/citation/15831296/Oxytocin_receptor_expression_in_smooth_muscle_cells_of_peritoneal_endometriotic_lesions_and_ovarian_endometriotic_cysts_

Does laparoscopic management of deep infiltrating endometriosis improve quality of life? A prospective study.

 Deep infiltrating endometriosis (DIE) can affect importantly patients'quality of life (QOL). The aim of this study is to evaluate the impact of the laparoscopic management of DIE on QOL after six months from treatment.MethodS: It is a prospective cohort study.

In a tertiary care university hospital, between April 2008 and December 2009, 100 patients underwent laparoscopic management of DIE and completed preoperatively and 6-months postoperatively a QOL questionnaire, the short form 36 (SF-36).Quality of life was measured through the SF-36 scores. Intra-operative details of disease site, number of lesions, type of intervention, period of hospital stay and peri-operative complications were noted.

Results: : Six months postoperatively all the women had a significant improvement in every scale of the SF-36 (p<0,0005). Among patients with intestinal DIE, significant differences in postoperative scores of SF-36 were not detected between patients submitted to nodule shaving and segmental resection (p>0.05). There were no significant differences in the SF-36 scores at 6 months from surgery between patients who received postoperative medical treatment and patients who did not (p>0.05).

Conclusions: : Laparoscopic excision of DIE lesions significantly improves general health and psycho-emotional status at six months from surgery without differences between patients submitted to intestinal segmental resection or intestinal nodule shaving.

Author: Mohamed MabroukGiulia MontanariManuela GuerriniGioia VillaSerena SolfriniClaudia VicenziGiuseppe MignemiLetizia ZannoniClarissa Frasca'Nadine Di DonatoChiara FacchiniSimona Del FornoElisa GeraciGiulia FerriniDiego RaimondoStefania AlvisiGiulia Gio

http://7thspace.com/headlines/399070/does_laparoscopic_management_of_deep_infiltrating_endometriosis_improve_quality_of_life_a_prospective_study.html

One in ten women ~ Endometriosis

Endometriosis from Endometriosis.org on Vimeo.

Massachusetts Adopts Groundbreaking Endometriosis Resolution

http://www.prweb.com/releases/2005/11/prweb306562.htm
Representative Elizabeth A. Poirier (R) introduces Endometriosis Awareness to Massachusetts with the resolution below urging increased awareness of endometriosis.
Email PDF Print .(PRWEB) November 5, 2005

Massachusetts House of Representatives

Urging Increased Awareness of Endometriosis

Whereas, Endometriosis is a painful, reproductive and immunological disease which is a leading cause of female infertility, chronic pelvic pain, and gynecological surgery, and accounts for nearly half the 600,000 hysterectomies performed annually, and endometriosis is more prevalent than Alzheimer's disease, Parkinson's disease and even Breast Cancer, that places significant costs for the individual, and the Commonwealth in medical bills and lost productivity; and

Whereas, Endometriosis can negatively affect a woman or teen's ability to work, attend school, social functions or care for herself and her family, and can frequently be misdiagnosed due to lack of awareness and understanding of the symptoms ; and

Whereas, Endometriosis symptoms include pelvic pain with or without menstruation, infertility, miscarriage, ectopic pregnancy, pain associated with sexual intercourse, gastrointestinal difficulties, fatigue, chronic pain, allergies and other immune system-related dysfunction and associations to diseases including multiple sclerosis, lupus, and fibromyalgia, and endometriosis can lead to painful internal scar tissue know as adhesions, resulting in a complex set of symptoms called Adhesion Related Disorder; and

Whereas, studies have also shown an elevated risk of certain cancers and autoimmune disorders in women with endometriosis and rarely, even malignant changes within the disease itself, thus researchers remain unsure as to the specific cause of endometriosis and there is no definitive cure, and current treatments are often accompanied by significantly negative side effects; and

Whereas, in recognition of the disabling effects endometriosis as a significant disabling disease in women, it is incumbent upon the citizens of the Commonwealth of Massachusetts to support the courageous individuals living and coping with this painful condition; therefore be it

Resolved, That the Massachusetts House of Representatives moves to promote Endometriosis Awareness Month every March and to encourage awareness of the Endometriosis Research Center, The Endometriosis Association, and The International Adhesion Society; and be it

Resolved, That a copy of these resolutions be forwarded by the clerk of the House of Representatives to the Endometriosis Association.

House of Representatives, adopted October 31, 2005

http://www.endometriosisassn.org/
http://www.endocenter.org/
http://www.adhesions.org/
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Teen finds relief from debilitating endometriosis

BY CYNTHIA BILLHARTZ GREGORIAN • cbillhartz@post-dispatch.com > 314-340-8114 STLtoday.com  |

Read more: http://www.stltoday.com/lifestyles/health-med-fit/fitness/article_aea7c10e-1f4f-5f7b-8353-1761f10c6d9e.html#ixzz1cjQpZ7fu
Endometriosis is a common disease by most standards. Between 6 percent and 10 percent of women of child-bearing age have the condition, which results when cells from the lining of the uterus grow in other parts of the body.

Yet many women, like Emily Ingargiola, endure intense and prolonged pain and the possibility of infertility because they're misdiagnosed or inadequately treated, says Dr. Patrick Yeung. He intends to change that.

In August, Yeung, one of a handful of OB-GYNs nationwide who call themselves "excisionists," joined SLUCare and formed the Center for Endometriosis at St. Mary's Health Center. Before that, he'd been practicing at Duke University, where he founded a similar center.

The main mission of the clinic, Yeung said, is to take seriously the women who come to him seeking pain relief. In those who prove to have endometriosis, he'll use a CO2 laser to excise it. All of it. No matter how big or small or where it is.

Most doctors only recognize some lesions as endometriosis and won't touch it on certain organs.

The center at St. Mary's also will study the value of excising endometriosis with CO2 lasers compared to more traditional removal methods such as cauterization and ablation, Yeung said. And it will become home to an endometrial tissue bank for further study.

Ingargiola, 19, of High Ridge, became Yeung's first patient shortly after he set up shop in St. Louis.

By then, she and her mother, Nancy Ingargiola, a registered nurse who has worked in obstetrics and gynecology, had grown frustrated with a medical system that initially refused to believe Emily had a problem.

Ingargiola's troubles started shortly after she reached puberty at age 14. At first she had extreme pain but just during menstruation.

Then she started urinating and defecating blood. Her periods were so heavy that she'd use a tampon and maxi-pad simultaneously and bleed through both. The pain started lasting all month, often leaving her doubled over, unable to go to school.

At first, she said, her doctors told her pain was normal. That she was being whiny. Then they said she had irritable bowel syndrome, most likely from stress.

She spent an entire month during her junior year of high school in the hospital. "It's really traumatic to have something going on in your body and having a lot of pain and having doctors not believe you and say that you're crazy," Emily Ingargiola said. "Not being listened to was the hardest part for me."

Finally, in March 2010, doctors at the Mayo Clinic suggested that maybe she had endometriosis. An ultrasound in St. Louis indicated that was likely. When hormone suppressants didn't work, doctors performed laparoscopic surgery and found severe endometriosis on her bladder, bowels, ureter, ovaries and pelvic lining. They ablated it twice. Ablation vaporizes endometrial lesions by either freezing, heating, microwaving or sending electrical currents through them.

It didn't work. The pain and endometriosis returned within weeks.

By this time, Ingargiola was enrolled at Bellarmine University in Louisville, Ky. Out of desperation, she began getting Lupron injections, which suppressed the endometriosis and induced menopause. The side effects were almost as bad as the pain.

"I turned into a different person," Ingargiola said. "I was getting hot flashes, I was completely unable to remember things or focus on school, and I had horrible mood swings."

She had been on Lupron for three months when her mother attended a medical conference and heard about Yeung.

Emily Ingargiola had the laparoscopic CO2 laser excision surgery Aug. 23.

THE TEXTBOOK PATIENT

Ingargiola is the type of patient Yeung hopes to help.

Many OB-GYNs have accepted that recurrences of pain and endometriosis after ablation and cauterization are normal, particularly in teenagers, he said.

But excisionists like Yeung who train at the Center for Endometriosis Care in Atlanta don't accept that.

They're taught to recognize subtle forms of the disease, including the slightest of spots, which other OB-GYNs either miss or dismiss as something else. Then they use a CO2 laser to cut out every last bit of it.

Most OB-GYNs only cauterize or ablate tissue on the surface of organs.

"You might be getting just the tip of the iceberg," Yeung said. "We know endometriosis can invade, and you can't tell which lesions are invading. I and others believe that excision, which is cutting out the entire implant down to healthy tissue, is the only way to 100 percent treat it."

Read more: http://www.stltoday.com/lifestyles/health-med-fit/fitness/article_aea7c10e-1f4f-5f7b-8353-1761f10c6d9e.html#ixzz1cjQa2nB i

Part 2 - Darcy Spears News Report on Lupron Depot - (KTVN, Las Vegas)