Two New Studies: Endometriosis & Effects on Partners

Love Couple Man Woman Holding Hands Relationship

In June 2017, two new studies were published both focusing on the effects of partners of women with Endometriosis.

In the first study we’ll be discussing (from The Journal of Obstetrics an Gynaecology Research), 51 partners of women with Endometriosis completed and returned questionnaires.  A breakdown:

  • 75% reported a negative affect on their own day-to-day life;
  • 52% felt their finances were affected (partly due to the fact that their partner’s weren’t able to work as much, if at all);
  • Although 70% of the partners were involved in the healthcare decision-making process, only 34% felt that healthcare providers had engaged them in that process;
  • 80% stated they hadn’t received information about dealing with Endo as a couple;
  • 74% reported on affect on sex life, mostly due to the pain it causes their partners. (All except 8 partners said they could not have sex because of the pain it caused);
  • 56% reported on affect on their relationship; and,
  • It suggested that better education and support be provided to partners of women with Endometriosis.  And it stated, “Involvement of partners from the beginning, normalization of symptoms, and education may assist in dealing with the burden of the disease.”

The second study, published in the Oxford Academic publication, Human Reproduction, included 22 male partners of women with Endometriosis answering questions.  In summary:

  • Nearly half of the participants stated sex was rare to non-existent.  This was due to pain, lack of desire due to medication, fatigue, stress, bleeding before/during sex, or even just feeling unattractive.  Four of the men stated matter of factly that they don’t want to pursue sex because it hurts their partners;
  • It affected the ability of many to have children, or frustrated efforts to conceive;
  • Many men reported a difficulty in their work due to taking time off of work to be with their partners, childcare, or household tasks.  Many of these men felt an added pressure to provide more income due to their partner’s inability to work as much (if at all);
  • New roles in the relationship developed since the diagnosis: accompanying them to appointments, taking time off work to care after surgery, household chores and tasks, child care, and a much deeper support role emotionally;
  • Most men expressed feeling helpless, frustrated, worried, and angry (anger was directed toward healthcare) regarding Endometriosis;
  • The majority of men felt there was a lacking of support for partners of people with Endometriosis.
  • And my favorite?  Many described that since the diagnosis, they’ve learned to become better partners:  caring, listening better, more supportive, has brought them closer, strengthened the relationship.

I am grateful for an understanding and supportive partner, but I also know that many women don’t have a partner who is as understanding.  And that breaks my heart.

If YOU are the partner of someone with Endo and are searching for support, consider joining the Braave support network (they’re on Facebook here); it’s specifically for partners of EndoSufferers.  If you know of any other support groups for partners of people with Endometriosis, please let me know! I’ll add them here.

And, both studies are linked below in our Resources section, if you’d like to read them.

 

Resources:

Braave – online support network for partners of women with Endometriosis

Oxford Academic Human Reproduction (Article, June 2017) – A Qualitative Study of the Impact of Endometriosis on Male Partners

The Journal of Obstetrics and Gynaecology Research (Article, June 2017) – Exploring the Impact of Endometriosis on Partners

 

A 1946 Study on Endometriosis

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While doing a bit of research for a recent blog entry, I ran across a study from 1946 describing Endometriosis.  I found it fascinating!

Written by Drs. Fallon, Brosnan, and Moran in Massachusetts, The New England Journal of Medicine published the study on November 7, 1946, and I wanted to point out some quotes that I found of particular interest:

frequent

missed

private

blueberry

octo

cramps

jarring.jpg

radium

all the babies.jpg

pox

time

To read the entire study yourself, please click here.  Groan if you will at reference to retrograde menstruation, treatment with castration, becoming a baby-factory, regression of the disease once the ovaries are removed, and…a cure. I just severely enjoyed the verbiage and disease descriptions from  70 years ago and wanted to share it with you.

Have a wonderful day!

~Lisa

Article: Management of Endometriosis-Related Pelvic Pain

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An article published in the April 2017 edition of The Obstetrician and Gynecologist offers a great breakdown of Endometriosis, the diagnostic journey, and treatment (both conventional and complementary) options.  It also encourages the use of support groups, mental healthcare professionals, and multidisciplinary medical teams.

If you’re interested, I encourage you to read the entire article here.  You may learn some new things, or just get affirmation of your present path of treatment.

Have a wonderful day!

~Lisa

New Study: migration of Endometriosis cells throughout the organs of mice

House_mouse

On April 6, 2017, Oncotarget published an article which I’ll be briefly discussing here today.

Researchers took mice and implanted Endometriosis cells inside of of their pelvic regions wanting to see if the Endometriosis cells would migrate to extra-pelvic organs.   They later analyzed the organs for microscopic Endometriosis-derived cells throughout the mice and found that it had migrated to the lungs, spleen, livers, and brains in many of the mice.

The authors suggest, “…that endometriosis in locations distant from the pelvis may be more common than previously recognized. Endometriosis should be considered a systemic disease that is often subclinical.”  They suggest that these Endometriosis-derived cells residing in other organs may influence symptoms of Endometriosis, such as fatigue, eating disorders, sociopsychological issues and other symptoms which lessen our quality of life.  It also discusses thoracic Endometriosis and Endometriosis on the liver, and those side effects.  Further research, of course, is always needed.

The entire published study is free for us to read and is very, very interesting.  I fully encourage you to click here and read the study and the conclusions.  And please feel free to correct me if you feel I’ve misread the science-y bits. ❤

Resources:

Oncotarget – (Article; April 2017) Micrometastasis of Endometriosis to Distant Organs in a Murine Model

 

~ Again, I am a layman.  I do not hold any college degrees, nor mastery of knowledge.  Please take what I say with a grain of salt.  If curious, do your own research 😉 Validate my writings.  Or challenge them.  And ALWAYS feel free to consult with your physician. Always.  Yours ~ Lisa

Endometriosis in the psoas major muscle

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An article was published on October 30, 2016 in the International Journal of Clinical and Experimental Medicine, which caught my interest.  We know that Endometriosis can grow in a lot of places other than the reproductive organs and pelvis.  This study found Endometriosis growing within a muscle: the psoas major muscle.

The pso-what-is muscle? Well, that’s what I said.

Psoas_major.gif

It’s a pair of muscles that run from the lumbar spine, along the back of the abdomen, and end inside the hip area. It helps flex our hips, aids our walking and running, and can improve posture.  In some places, it’s as thick as a wrist!  As a side-note, weak psoas muscles can cause back pain, hip pain, limited movement in the hips, tight/deep pelvic pain, belly aches, constipation, and a twisted pelvis.  Dr. Axe offers some tips, tricks, and stretches to help strengthen your psoas muscles.

Okay, now back to the study!

A 49-year-old Chinese woman was admitted to the hospital because she had increased CA-125 levels.  If you’ve followed my previous blogs, you’ll remember this could be an indication of the presence of Endometriosis. Seven years prior, she had a hysterectomy and oopherectomy (removal of her right ovary) – she had a uterine myoma and ovarian Endometriosis.

After screening and testing, the doctors found a mass in the left side of her psoas muscle and thought she had a tumor.  She didn’t have any of the usual signs and symptoms of Endometriosis.  She was discharged from the hospital (at her insistance).

Three months later she returned for an MRI.  The mass had grown by 3cm and was also involved with her iliac vessels.  Her CA-125 levels were still increased.  And her physicians needed answers.  An exploratory laparotomy was performed and the mass was visualized in her psoas major muscle.  It was 10x10x8 cm and was inside the muscle tissue.  They continue to fear it was a tumor.

Rather than remove the mass in its entirety, a portion was removed and biopsied: confirmed as Endometriosis.  She received more than 3 months of Lupron Depot and the remaining mass decreased in size and her CA-125 levels stabilized.  The authors surmise the lesion may have transplanted during prior surgeries and hope this case report sheds further light on the illness.

Yet another example of extra-pelvic Endometriosis, as well as post-hysterectomy Endometriosis.  Here’s to hoping this case study continues to push the medical and scientific community into further research and greater funding toward better understanding Endometriosis – and one day finding that much-needed cure.

Resources:

Dr. Axe

International Journal of Clinical and Experimental Medicine – Article (Oct. 2016) Endometriosis in the Psoas Major Muscle: A Case Report

Yoga International

~ Again, I am a layman.  I do not hold any college degrees, nor mastery of knowledge.  Please take what I say with a grain of salt.  If curious, do your own research 🙂 Validate my writings.  Or challenge them.  And ALWAYS feel free to consult with your physician. Always.  Yours ~ Lisa

Blood Biomarkers & Endometriosis

Vacutainer_blood_bottles

You may have read some of my previous blogs about biomarkers…blood tests for things which may help doctors diagnose Endometriosis without surgery, such as CA-125 levels.  There are a lot of hopes that indicators may help save costly diagnostic surgeries, surgical risks, and painful recoveries.

A study published on May 1, 2016, reviewed 141 past studies and analyzed the data.

It does not look good for us, ladies and gents.  Well, not yet at least.  It concludes, “Overall, there is not enough evidence to recommend testing for any blood biomarker in clinical practice to diagnose endometriosis.”  If you’d like to read it for yourself, please click here.

A study published on July 27, 2016, however, holds hope that the CA-125 test may “rule in” Endometriosis.  You can read it here.  It is supported by a December 2016 study, which you can read here.  Unfortunately, a 2017 study (read it here) found that due to the fluctuating levels of CA-125 throughout a woman’s menstrual cycle, as well as the fact that CA-125 is not exclusive to Endomtriosis, does not make it a recommended diagnostic tool (yet).

A November, 2016 publication stated that women with Endometriosis may have elevated MiRNA (micro RNA) gene biomarkers.  Strides are being made to identify proteins and glycoproteins (like CA-125) that may be more prevalent in women with Endometriosis.  Although inflammation is a major syptom of Endometriosis, research into cytokines and chemokines (which may point to inflammation) appear equal in women with and without Endometriosis.  However, potential is being shown for using IL-8, TNF-α, and CA125 as a combined biomarker panel to help diagnose the presence of Endometriosis.  Research into identifying biomarkers in urine and peritoneal fluid is also ongoing.  All the science in this is waaaaaay over my head…but if it leads you to a specific conversation with your doctor, or delves you deeper into researching it yourself, my job here is done!  You can read it here.

Hoping that future research can continue to push forward on non-invasive diagnostic tools.

*Updated April 6, 2017*

~ Again, I am a layman.  I do not hold any college degrees, nor mastery of knowledge.  Please take what I say with a grain of salt.  If curious, do your own research 😉 Validate my writings.  Or challenge them.  And ALWAYS feel free to consult with your physician. Always.  Yours ~ Lisa

Inflammation & Endo

justlogoinflam

The Oxford Dictionary defines inflammation as, “a localized physical condition in which part of the body becomes reddened, swollen, hot, and often painful, especially as a reaction to injury and infection.”

An article which is slated to be published in June 2016’s Frontiers in Bioscience reviews previous studies and literature which discuss how inflammation may cause Endometriosis to develop.  It states, “…inflammation is crucial in the pathogenesis of endometriosis…” Pathogenesis is the development of a disease; the cellular events and mechanisms that lead to a disease.

It also discusses how estrogen can affect inflammation which, in turn, affects Endometriosis.  It points out that anti-inflammatory medication and GnRH analog drugs (such as the highly-controversial Lupron Depot which depletes our estrogen production) have been found to reduce inflammation in Endometriosis patients.

Remember our blog about stress and Endometriosis?  This June 2016 study identifies that stress hormones may also play a role in creating inflammation and aggravating Endometriosis.

The authors theorize that inflammation may not only play a role in the development of Endometriosis, but that Endometriosis may contribute to pelvic inflammatory disease.  Imagine if you will a snowball effect : stress = inflammation + estrogen = Endometriosis + more inflammation = pelvic inflammatory disease or other illnesses.

A study published in Fertility & Sterility (Oct. 2017) also showed that inflammation may play a role in the development of Endometriosis, especially peritoneal cavity inflammation.  It concludes “therapeutic strategies focused on reducing peritoneal inflammation may be effective in limiting the development, progression or recurrence of endometriosis.”

I may not have understood a lot of the science mumbo-jumbo of the article, but I did certainly walk away with one thing : inflammation is noooo bueno and I will do anything I can do to naturally reduce my body’s inflammation.

Diet plays a huge role in reducing inflammation.  You have to decide what aids and hinders your body…not just do what “works for everyone else.”  You may have heard this all before, but :

  • Omega-3 fatty acids, like those found in salmon or tuna, are great at reducing inflammation.  Don’t like fish but take fish oil caplets?  Be careful; Omega-6 fatty acids, which may be found in fish oil supplements, may spurn inflammation rather than quell it.
  • Nuts are also a great sort of antioxidants and Omega-3s.  Try walnuts or almonds.
  • Whole grains contain a lot of fiber, which may decrease inflammation.
  • Eat your fruits & veggies.  Leafy greens, broccoli, tomatoes, beets, garlic, onions, berries, and cherries (the tart ones) all have amazing properties that combat inflammation.
  • Ginger and turmeric, two very ugly roots which are common spices, also have properties which are well-known to fight inflammation.  Cinnamon has also been found to be anti-inflammatory.
  • Don’t forget about herbs!  Rosemary, thyme, sage, and oregano are among the top 10 herbs and spices for fighting inflammation.
  • Extra virgin olive oil has been found to have similar anti-inflammatory properties to NSAIDs (i.e, Ibuprofen, Naproxen Sodium).

Dr. Andrew Weil has created a fun graphic known as the Anti-Inflammatory Food Pyramid.  If you like visual aids, click here.

There’s also a list of foods that promote inflammation, which you may want to avoid (if you’re able to).  These include dairy, soy, red meat, and foods that are high in saturated fat and sugar. Some people are affected by a gluten sensitivity or intolerance, which flare up their inflammation and symptoms.

Also, try to reduce your stress levels.  In any way : stretching, meditation, yoga, medication, rest, a different job, removing toxic people from your life, etc.

I repeat : do what feels good and works well for you.  Pay no mind to someone else if they say “this works,” but you’ve tried it and it doesn’t make you feel any better…or if it makes you feel worse.  You, and only you, really know your body.

*Updated September 12, 2017*

Resources:

Body Ecology10 Top Foods that Prevent Inflammation in Your Body

Center for Disease Control and Prevention – Pelvic Inflammatory Disease

Fertility & Sterility (Article; Oct. 2017) – Effect of Inflammatory Environment on Development of Endometriosis in Murine Model

Health.com14 Foods that Fight Inflammation

Mercola Top Anti-Inflammatory Food, Herbs, and Spices

U.S. National Library of Medicine (Abstract; June 2016) – Inflammation and Endometriosis; the full article is available for purchase from Frontiers in Bioscience

Women to WomenReducing Inflammation – The Natural Approach

A biiiig thank you to Gary for his help in securing the entire article for me to read.  I truly appreciate you.

~ Again, I am a layman.  I do not hold any college degrees, nor mastery of knowledge.  Please take what I say with a grain of salt.  If curious, do your own research 😉 Validate my writings.  Or challenge them.  And ALWAYS feel free to consult with your physician. Always.  Yours ~ Lisa

Endometriosis & Iron Levels

dumbbell
(…no, not that kind of iron)

So, if you’re reading this you probably already know a little bit about Endometriosis.  One of those facts is that the Endometriosis implants/lesions shed (or bleed) inside the pelvic cavity (or wherever else the Endo is located).  Another fact is that women with Endometriosis tend to have much longer and heavier periods than women who do not suffer from Endo.  Recently at our support group meeting, the question of iron levels and anemia came up.   With all that bleeding, can we suffer from anemia or an iron deficiency?

And, again, the topic of iron levels and Endo came up at our Endometriosis Awareness & Support Walk : could the blood left in my pelvic region from shedding Endo have caused the “abnormally high” iron levels during a blood test?

Just what does Endometriosis and iron do to our bodies?  Anemia? An iron deficiency?  High levels of iron? What does iron do?  Why do we need it?  All of these questions have been swimming around in my head and its’ time to get them out…and you know what that means : RESEARCH!

I don’t know about you, but every time I swallow a multivitamin with iron in it, I’m throwing up within five minutes.  When I spoke with my primary care physician a few years ago about iron making me throw up, he asked me why I was taking it.  My response was simply, “Because I thought I had to…”  He clucked his tongue, shook his head, and told me he generally only advised pregnant women to take iron.  So, I steer clear of iron supplements or vitamins that contain any iron.

Anyway, on with the research!

 

Iron Deficiency:

How do you know if you have an iron deficiency?  Symptoms may include shortness of breath while exerting, fatigue, weakness, dizziness, an urge to eat ice, headaches, depression, temperature sensitivity, a sore tongue, restless leg syndrome, an increase of infections, poor muscle coordination, and a decreased mental function.

Many women who are anemic suffer from an iron deficiency (without iron, enough red blood cells cannot be created/maintained and less oxygen is delivered throughout the body).   This deficiency may be due to blood loss, a lack of red meat in a diet, their bodies may have trouble absorbing iron, they may not take enough vitamins, GI issues, or some diseases such as fibroids or cancer.

According to the Iron Disorders Institute, blood loss may be due to heavy menstruation, Endometriosis, and fibroids, which may lead to anemia.  An average healthy woman’s body increases iron absorption during her period to make up for the loss of blood during her cycle.  With Endo, we tend to have lengthy or heavy periods and the iron regulatory systems in our bodies may not be able to properly regulate the amount of blood (and iron) we are losing, leading to anemia.  With that being said; however, a 2006 study claims to debunk the theory that heavy periods lead to anemia.

You can also not get enough iron into your body through diet and supplements, which can lead to anemia.  The Center for Disease Control estimates that only one-fourth of women between 12-49 years old meet the daily recommendation of iron intake.  Red meat is supposedly the best food-source for iron, which, for many following the Endo diet, is out of the question.  If you must eat red meat, try to get the organic, grass-fed beef.  Also, eggs, beans, fish, nuts, dried fruits, whole grains, and dark leafy vegetables are rich in iron.  A word of warning, calcium may inhibit the absorption of iron.  A healthy digestive system and nutrient-rich diet is critical to ensure good iron absorption.

Looking to restore your iron levels if you’re anemic?  Adjust your diet or talk to your physician about iron supplements (taking it orally, injecting it, or infusions) or, in extreme cases, a blood transfusion may be necessary.

Too Much Iron:

Too much iron may be indicated by chronic fatigue, joint pain, abdominal pain, skin color changes, the loss of your period, loss of libido, and even hair loss.

Women who no longer have their periods are at risk for having too much iron in their systems.  (This is interesting to me since I’m on the pill and haven’t bled since Sept. 25, 2014).  Other causes of heightened levels of iron could include hereditary factors, genetic mutations in the cells, autoimmune diseases, or an iron overload due to blood transfusions, excessive alcohol, or too much iron supplementation in the diet.

Some of the risks of having too much iron include premature heart attack (especially of interest given recent studies that women with Endo are at a higher risk of heart disease), diabetes, liver disease, osteoarthritis, and hormonal imbalances.

How Can I Know My Iron Levels?

You an ask your physician to order a blood panel.  Give up a vial or two of blood, lab work is done, and *presto* you have a magical piece of paper that only medical professionals can understand.  You may prod your doctor asking to check your ferritin, transferrin, iron,  TIBC (total iron-binding capacity), CBC (complete blood count), and reticulocyte count.  You may even want him/her to order a check on your thyroid levels, as these may come into play.

Or you can contact and pay Health e-Iron to test you with their FeGGT LifePro test.  (I don’t know or endorse these guys…just found them through the Iron Disorders Institute webpage).

Iron & Endometriosis

A study published in 2002 found that the iron concentrations in the peritoneal fluid of the pelvic cavity of women with Endometriosis was higher than women without, and that those high concentrations remained throughout each stage of the disease.  It also found that the higher iron concentrations were found alongside the lesions, suggesting a link between the two.  The study surmised that “…cellular defenses might be overwhelmed owing to repeated bleeding of lesions…” and further research was needed.

A study in 2006 proved that iron deposits and iron overload are found within the pelvic cavity where Endometriosis is present and may contribute to the growth and spread of the disease.  Lab rats who were treated with an “iron chelator” known as Desferoxamine (aka DFO) had less iron deposits, less cell growth, and less iron concentrations!  An iron chelator is a drug which removes excess iron from the body.  The study concluded that iron may contribute to the growth of the disease and the use of an iron chelator may be beneficial to help control iron levels in women with Endometriosis.  A 2009 study confirmed the findings that iron chelators may prove beneficial in reducing iron overload and controlling inflammation.

In 2008 several scientists from the 2006 study published another.  This time it was to review and discuss the potential consequences of iron overload in women with Endometriosis.  Again, they conclude that treatment using an iron chelator with Endometriosis patients should be considered to help lessen the effects of iron overload.  Table 1 of the 2008 study identifies 21 prior studies which demonstrate iron overload in women with Endometriosis (click here).   The study suggests that women with Endometriosis are unable to stabilize the amounts of iron in their bodies as easily as women who do not suffer from Endo.  These excess iron levels may contribute to the development of Endometriosis, add to inflammation, or even aggravate symptoms.

Now what?

I found it interesting reading different articles, blogs, and studies today.  In one corner, you have the “eat iron-rich foods and take supplements to make up for what you lose during your period” campaign – and in the opposite corner, you have the “women with Endometriosis have an iron overload.”  And throw in the 2006 study that blood loss during a period doesn’t lead to anemia.  So just what to do?

I think Step One is talk to your physician (well, I plan to).  My next appointment with my Endo doc/gyno is on April 12, 2016 for my annual exam & check-up.  I also want to ask him his opinion regarding menstruation and anemia and/or an iron deficiency.  After that appointment, he always orders my blood work so it works out perfectly : I’m going to ask him if he can test my iron & Vitamin B levels.  Depending on those results, I’ll think about Step Two.

Possible Step Two(s):

a.  Increase the amount of iron-rich foods in my diet (if I’m iron deficient);

b.  Find a good iron supplement that’s right for my body (if I’m iron deficient);

c.  Talk about iron chelators (if I have too much iron);

d.  Do nothing different than what I have been doing (assuming my numbers are juuuust fine).

What are you going to do?  And what are your thoughts on iron, anemia, and Endometriosis?

(and thanks for reading!)

 

Resources:

American Journal of Human Biology – (2006; Article) Menstruation Does Not Cause Anemia: Endometrial Thickness Correlates Positively with Erythrocyte Count and Hemoglobin Concentration in Premenopausal Women

American Red CrossIron Information for All Donors

Endometriosis.org Overload of Iron in the Pelvic Cavity May Promote Proliferation of Endometriosis Lesions’ Epithelial Cells

Every Day Health

Fertility & Sterility – (Oct. 2002, Article) Iron Overload in the Peritoneal Cavity of Women with Pelvic Endometriosis

Health e-Iron, LLC

Human Reproduction– (July 2006, Article) Iron Overload Enhances Epithelial Cells in Endometriotic Lesions Induced in a Murine Model

Iron Disorders InstituteIron Deficiency Anemia

Iron Disorders Institute – Iron Out-of-Balance in Women

Iron Disorders InstituteIron Overload

Lab Tests Online

Livestrong Iron-Rich Foods for Iron-Deficiency and Anemia

Mary Vance NC

Molecular Human Reproduction – (May 2008, Article) Potential Involvement of Iron in the Pathogenesis of Peritoneal Endometriosis

National Heart, Lung, and Blood Institute

NHS.uk

Scientific American – (July 2011, Article) Iron-Deficiency is Not Something You Get Just for Being a Lady

SelfGrowth.com

The Curriculum in Iron Metabolism & Related DisordersIron Chelation Basics

US National Library of Medicine – (Sept. 2006, Abstract) Menstruation Does Not Cause Anemia: Endometrial Thickness Correlates Positively with Erythrocyte Count and Hemoglobin Concentration in Premenopausal Women

US National Library of Medicine – (Dec. 2009, Article) Synthetic and Natural Iron Chelators: Therapeutic Potential and Clinical Use

US National Library of Medicine – (Jan. 2009, Abstract) The Role of Iron in the Pathogenesis of Endometriosis

~ Again, I am a layman.  I do not hold any college degrees, nor mastery of knowledge.  Please take what I say with a grain of salt.  If curious, do your own research 😉 Validate my writings.  Or challenge them.  And ALWAYS feel free to consult with your physician. Always.  Yours ~ Lisa

New Pill? Viagra for Women!

lilpinkpil

You may have heard in recent news that the an FDA advisory committee is pushing for the approval of a new drug, Flibanserin, which is being hailed as “viagra for women,”  and decision by the FDA is expected on or before August 18, 2015. Many women suffer from a low sex drive for many different reasons.  I myself have suffered with one since my Lupron Depot injections, which were immediately followed by a continuous birth control.  My libido is nearly non-existent nowadays. Blah.

But what is this drug? What are the potential side effects? How long were the clinical trials?  All of these questions come running to the tip of my tongue – will the pros outweigh the cons?  Will there be interactions with my birth control pill?  Less questions, MORE RESEARCH!

Flibanserin

In 2006, Flibanserin was first tested and developed by a German pharmaceutical company, Boehringer, as an anti-depressant medication. The drug lowers serotonin while raising dopamine, and norepinephrine levels in a woman’s brain.  The initial anti-depressant trials of the drug with women showed an increase in sexual desire, which prompted new studies with thousands of women.  The hope was to pass it off as a libido-increasing drug to combat the affects of hypoactive sexual desire disorder (HSDD).  However, due to it’s failed attempts at FDA approval to treat HSDD, Boehringer sold the rights of the drug to Sprout Pharmaceuticals in 2011. Sprout Pharmaceuticals filed their patent in 2014.

Sprout Pharmaceuticals was developed in 2011, solely for the purpose of creating a libido-enhancing drug for women.  They have not produced any drugs on the market, to date.  However, several of their executive team hail from other pharmaceutical companies such as Slate Pharmacueticals (manufactured Testopel), Halozyme Therapeutics (manufactured Hylenex), Actient Pharmaceuticals (a company which acquires pharmaceutical companies), Hyman Phelps & McNamara (a food & drug law firm), and AAI Pharma (a pharmaceutical testing company).

The suggested dosage for women would be 100mg per day, likely taken at night.  For some women in the clinical trials, it took 4-8 weeks before they felt any improved sexual response.

There is a huge lobbying campaign by several women’s groups to approve this drug, stating that men have a lot of approved libido-enhancing drugs, where women have zero.  I see their point…but…safety first!  The National Women’s Health Network strongly opposed the drug’s approval at the recent hearing due to concerns over side effects.

Potential Side Effects

Since 2010, the FDA rejected Flibanserin’s approval due to concerns over the side effects, which may include dizziness, fainting, sleepiness, low blood pressure, and nausea.  Sprout Pharmaceuticals has tried twice since 2013 to have the FDA approve the drug, and failed.

Side effects may be worsened by prescription drugs (particularly, birth control pills) and/or alcohol.  There were also concerns expressed at the advisory committee hearing over a potential for increased accidents (trips, falls, vehicle collisions, etc.) due to these side effects.  Reportedly, one woman reacted so poorly in a clinical trial that she had to be hospitalized.

However, the advisory committee feels that with proper warnings and labels, this drug has the potential to change the lives of a lot of women, and their significant others.   They are also hoping a bona fide, approved drug will help steer women clear of unsafe internet wonders and snake oil treatments for lowered libidos.

Studies

There are countless reports and studies regarding Flibanserin available to you through the interwebs.  I will discuss a few here, but for a comprehensive list, please click here.

Sprout Pharmaceuticals ran a 24-week trial, and the results showed that the Flibanserin had positive effects for 46-60% of the women taking that pill; however, the advisory committee altered those numbers once they figured in the placebo pill.  After the committee’s alterations, they found only 10% of women had positive feedback; which was about an increase of one sexually satisfying event per month.  The advisory committee stated that the drug had “marginal to moderate” results.

There was also a two-year cancer study on the effects of raised dosages in mice, which found an increased risk of breast cancer tumors (these mice received four-times the recommended dosage).  There are reports that studies of Flibanserin lasted anywhere from one year to 18 months, and the FDA is concerned over the lack of time taken to evaluate any potential cancer risks.  Sprout Pharmaceuticals reminded the advisory committee that just because studies in lab animals shows an increased potential for developing breast cancer, doesn’t mean those study results will transfer over to humans…

What Now?

The advisory committee has begun preparing their recommendation package to be presented to the FDA to aid in their decision.  This will include suggested warning labels, educational materials, training for professionals who will prescribe this medication, etc.

Some members of the advisory committee who voted against the pill’s approval are concerned over a lack of data and information, and feel the benefits do not outweigh the risks.

My 0.02

I hate taking pills.  I hate feeling ill from taking pills even more.  I especially run from pills that may potentially harm me, or come with ludicrous warning labels and side effects.  Just not worth it.

I’ve always felt that Big Pharma is lookin’ for that Next Big Thing to make a buck.  Many people do not agree that this pill is the “viagra for women” since the chemical and physical reactions of viagra versus Flibanserin are completely different: it does not increase blood flow to a sexual organ; it increases and decreases chemicals within the woman’s brain to alter sexual interest.  “Viagra for women” may be a general misleading and miscategorized statement.

So, if this pill hits the market, I’ll avoid it.  A little prompting by my very patient partner goes a long way in reminding me just how much I’ve missed sex.  Just because I don’t have a sense of initiation any further doesn’t mean I want it any less.  I just…forget…how much I want it.  However, that being said, I know there are a lot of women who may want to pursue this little pill route; and more power to them.

But I am curious and will continue to follow these stories as they break.

What are YOUR thoughts? I’d love to hear them…leave a comment below.

Resources:

AAI Pharma

Flibanserin-HSDD – timeline

Forbes – 6/4/15 article

Google Patents – September 2014 – Method for the Treatment of Premenstrual and other Female Sexual Disorders

Google Patents – June 2014 – Use of Flibanserin for the Treatment of Post Menopausal Sexual Desire Disorders

GTCR – re: Actient Pharmaceuticals

Halozyme

Hyman, Phelps & McNamara, P.C.

International Business Times – 6/8/15 article

MedCity News – 4/4/12 article

National Post – 6/5/15 article

National Women’s Health Network – 6/3/15 press release

Science 2.0 – 6/6/15 article

Sprout Pharmaceuticals – 2013 (Article) – Efficacy of Flibanserin in Women with Hypoactive Sexual Desire Disorder : Results from the Begonia Trial (the 24-week study)

Sprout Pharmaceuticals – 2/11/14 press release

Sprout Pharmaceuticals – 6/5/15 press release

Sprout Pharmaceuticals – executive leadership information

Tech Times – 6/8/15 article

Thomas Reuters – 2014 (Abstract) – Flibanserin for Female Sexual Dysfunction

US News – 6/3/15 article

~ Again, I am a layman.  I do not hold any college degrees, nor mastery of knowledge.  Please take what I say with a grain of salt.  If curious, do your own research 😉 Validate my writings.  Or challenge them.  And ALWAYS feel free to consult with your physician. Always.  Yours ~ Lisa