New Study: Elagolix vs. Lupron (Cost Effectiveness & Quality of Life)

Red apple and green apple
Comparing apples to…apples? Image by Freestocks.org

This will be a highly-charged opinion piece for me…so as you read what I am writing, please know that I am seething and upset and just needed to vent.

A study of Elagolix (aka Orilissa) hit my inbox recently and I just opened it today. It was run by Abbvie, of course. And it compares Elagolix to Lupron to see which is more cost-effective in possibly giving women with Endo a greater quality of life. So, it’s win-win for Abbvie since they make both of those drugs…

Elagolix was deemed the “winner” in that it costs patients less money and possibly grants them a greater quality of life with a possibility fewer side effects.

And why am I seething? That sounds great!

  • a) It’s the same damn company comparing two similar drugs that it manufactures,
  • b) both are laden with possible shit-tastic side effects,
  • c) both can only be taken for a minimum amount of time , and
  • d)…the best for last: San Diego’s own Dr. Agarwal is listed as an author, a consultant for Abbvie’s research, and he helped with the “inception, design, and analysis” of this study. The same Dr. Agarwal who accepted $315,000 from Abbvie from 2013-2017. And I’ve been told my many of his Endo patients that he often pushes Lupron and Elagolix for treatments.

Does it make me want to consider taking Elagolix to manage my Endo pain? Not one bit.

I was on Lupron for six months and it was one of the hardest things I’ve ever done, physically and mentally. Many people I’ve talked to had horrendous side effects and continued to have them long after quitting the treatments. And ABC 10 News interviewed several of our local EndoSisters about their Lupron experiences. It’s my understanding that Elagolix is very similar to Lupron…so I’ve zero desire to put my mind and body through such torture again…for a temporary, limited-use band-aid drug. But, I will always say this: don’t let my opinion sway you from a treatment option.

A fellow EndoSister, Magda, has a different perspective and she has given me permission to share her words today:

“I had a very good experience meeting with Dr A a few months ago finally so I don’t agree with a lot of the comments made about him. 

“I’m on a different study, for [redacted] which is similar but not one he is associated with and he thanked me for doing so even, and honestly my endo pain surprisingly enough I feel is quite nonexistent at this point, around 8 weeks in on non-placebo drug. Obviously if some saw me in a walker this last weekend it’s bc I need surgery on my hip from the labral tear because of a car accident but I’m beyond grateful that my endo is finally under control with one of the newest drugs out there for it, and with the addback therapy I haven’t seen any real side effects I’ve noted. In 2 weeks I’ll have my bone density rechecked so we can see where that is but I feel grateful to finally be on something helping control my endo pain, especially with limited side effects. 

“Since surgery is clearly not an end all option for our disease we’ve all learned maybe we should keep an open mind that there are some doctors out there that are truly trying to actually find a solution to at least help control our daily symptoms and in my opinion that is what Dr A is doing with his current practices, as a cure is not that simple. Unfortunately most diseases don’t have a cure, all kind of people take daily meds for all kind of things, like high blood pressure, diabetes, thyroid problems, high cholesterol, migraines, I could go on and on and on……trust me I get it. I literally cried my eyes out earlier this year the first day a doctor told me I was in denial that I had endometriosis and needed to be doing something about it, but mainly because I realized she was right. I also realized there are a lot worse things in life and in some case way worse conditions, especially some that don’t have a few pills that can help lower the pain levels or even possibly not help you in staying alive.

“So I count my blessings that I finally know what’s caused my pain, even though it took a long 21 painful years and a horrendous almost near death experience in the hospital last year just to get a diagnosis and finally know, but at least now I know and I’m doing something about it.

“That’s why I joined a study. To help not only myself but all the countless women who might still not know, and especially the children, more specifically the ones in my family that might be the unlucky ones to get this disease as well…..everyone has their own choices to make in life. I’ve made mine to help make a difference in any way I can. My question is what are you doing to help. If not others, at least for yourself. God put doctors and scientists on this earth to work on and help possibly eventually find cures, or at least medications that can help, that’s what the current studies out there are for. Without patients willing to help test the products, they will not be able to help us. And who knows, maybe you will actually feel better in the process. I know I do. And I at least have that to be grateful for. That’s my food for thought on this topic. “

Please, please, PLEASE do your own research and know what you’re getting into first: read the entire FDA drug pamphlets, analyze the studies, talk to others that have tried it, and question your healthcare providers. Most importantly: trust your gut. The decision is yours, and yours alone.

Resources:

Future Medicine – (Article, Feb. 2019) Cost–effectiveness of elagolix versus leuprolide acetate for treating moderate-to-severe endometriosis pain in the USA

New Clinical Trial for Endometriosis Pain

Icon of doctor and patient for clinical trial

An EndoSister shared a page with me describing a new clinical trial for women suffering with Endometriosis pain. It’s a vaginal ring that delivers *some type* of medication. There wasn’t much information on the site about what type of medication…

If you’re interested in seeing if you qualify for the clinical trial, you can submit your application by answering a few questions on ResearchMyEndo’s site. Once you’re talking to a representative, be sure to ask questions like what type of medication is it (pain medication? GnRH agonist? GnRH antagonist? potential side effects? options to leave the study, etc.) AND (most importantly), you may not want to read any further of this blog entry because I don’t want to reduce your chances of being accepted if researching the product is a disqualifying factor.

I will never tell you what to do, or not to do. The decision to participate in a clinical trial is wholly yours. It may help your symptoms. There’s always a risk with clinical trials…who knows what side effects await you. BUT…it’s a personal decision. Don’t make it lightly – but do feel free to make the decision that is right for you.


A domain owner search of ResearchMyEndo’s site simply shows that the domain is owned by GoDaddy and was purchased in April of 2019. So, I can’t actually snoop around to see what pharmaceutical company, if any, has sponsored the site…

The ONLY clinical trials currently recruiting I could find dealing with a vaginal ring and Endometriosis involved Ferring Pharmaceuticals and a drug known as Quinagolide. In the past, there were studies using vaginal rings to deliver leuprolide (yep…good ol’ Lupron) and Danazol.

Quinagolide is a “non-ergot-derived selective dopamine D2 receptor agonist” used to treat elevated levels of prolactin (a hormone secreted by the pituitary gland). Prolactin has been shown to have over 300 functions in the body, including the “reproductive, metabolic, regulation of fluids (osmoregulation), regulation of the immune system (immunoregulation) and behavioural functions.”

According to Drugbank, the most common side effects of Quinagolide use include “nausea, vomiting, headache, dizziness and fatigue that usually appear in the beginning of initial therapy. Less frequent side effects (1 to 10%) include anorexia, abdominal pain, constipation or diarrhoea, insomnia, oedema, flushing, nasal congestion and hypotension. Orthostatic hypotension may result in faintness or syncope.”

According to Google Patents (filed by Ferring Pharmaceuticals), a pilot study was conducted of nine women to test Quinagolide in humans. The women had several of their Endometriosis lesions removed and biopsied, and additional lesions were left inside their bodies but marked with a silk knot and photographed. One week after surgery, these women began treating with Quinagoilde orally for four months and underwent exploratory surgery again. The marked areas were excised and biopsied (any adhesions were also removed). The surgeons who performed the laparoscopies believes the treatment significantly reduced the severity of Endometriosis in the patients. The study boasts that “the quinagolide treatment induced a 68% reduction in size with 35% lesions vanishing after 18-20 weeks treatment…The quinagolide may significantly decrease the blood vessels (vascularisation) in the endometrioic lesions; indicating increased tissue degeneration and hence reduction of the endometriotic tissue on a microscopic scale.”


On to the clinical trials (if you can’t tell, click on the trial title to be directed to their Clinical Trial page for more info):

Randomized Trial Assessing Quinagolide Vaginal Ring for Endometriosis-Related Pain

First posted in October of 2018, the purpose of this study is to test the efficacy of quinagolide (aka Norprolac) being released via a vaginal ring in the hopes of treating moderate to severe Endometriosis-related pain. Some participants will receive a placebo treatment. The sponsor of this study is Ferring Pharmaceuticals, who acquired worldwide manufacturing, marketing and distribution rights of Norprolac back in 2004.

It’s estimated this study will be concluded by April 2022. It’s recruiting now. You can contact Global Clinical Compliance for more information. They are currently recruiting in Arkansas, California, Florida, Illinois, Iowa, Louisiana, North Carolina, Pennsylvania, Texas, and Virginia.

Quinagolide Vaginal Ring on Lesion Reduction Assessed by MRI in women with endometriosis/ adenomyosis

This study is not yet recruiting. It is again sponsored by Ferring Pharmaceuticals and will investigate the effectiveness of the quinagolide ring to reduce lesion size (assessed by MRI) in women with Endometriosis, deep infiltrating Endometriosis, and/or adenomyosis. It is expected to start recruiting participants in June of 2019 and complete in December of 2020.

You can contact Global Clinical Compliance for more information. It appears they will be recruiting in Denmark, Germany, Italy, and Spain.


Again, I have no way of verifying if the trials I found are related to the trial offered on ResearchmyEndo. But…be sure to ask questions and only do what you feel is right for you.

Before I close, I do want to point out an area of frustration for me: ResearchmyEndo’s definition of Endometriosis (I snapped a screenshot and highlighted it for you)…Not only does it (wrongfully) identify Endometriosis as the lining of the uterus (it’s SIMILAR, but not the same), BUT they severely downplay the seriousness and severity of recovery of a laparoscopy. And I specifically despise the fact that the surgeon will “sometimes remove endometriosis tissue.” UGH! Crappy definition. And sub-par care! Meh…

Screenshot of Researchmyendo.com's definition of Endometriosis

Resources:

Clinical Trials – Randomized Trial Assessing Quinagolide Vaginal Ring for Endometriosis-Related Pain (RAQUEL)

Clinical Trials – Quinagolide Vaginal Ring on Lesion Reduction Assessed by MRI in Women with Endometriosis/Adenomyosis (QLARITY)

Drugbank – Quinagolide

EndometriosisNews (2016) Intravaginal Ring to Possibly Treat Endometriosis Shows Potential in Proof of Concept Trial

Ferring – Ferring Acquires Norprolac

Google Patents – Use of Quinagolide in the Treatment of Endometriosis, Pain and Cancer

Journal of Controlled Release – (2016) A Novel Approach to Administration of Peptides in Women: Systematic Absorption of a GnRH Agonist Via Transvaginal Ring Delivery System

Journal of Obstetrics & Gynaecology Canada – (2015) Vaginally Administered Danazol: an Overlooked Option in the Treatment of Rectovaginal Endometriosis?

Patientwing – clinical trials of quinagolide vaginal ring for endometriosis in the United States

Whois – domain search

You and Your Hormones – Prolactin

~ 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

Research OutSmarts Endometriosis Study is ongoing

ROSE-logo-FINAL1

The ResearchOutSmarts Endometriosis (ROSE) Study has been ongoing for a few years and they still need our help.  They received the 2018 Innovation Challenge Award for researching potential diagnostic tests for menstrual effluent (aka period blood) – congratulations you guys!!  I’ve participated in the study and so can you. Yes, you!!  But you must be over the age of 18 and NOT pregnant or breastfeeding.   Don’t live in the New York area and feel like you can’t help in any way? That’s not true!  You can work via e-mail and express mail.

What’s the study all about?  Per their webpage, “The goal of the ROSE study is to investigate the causes of endometriosis and bring improved diagnostics and treatments for women with endometriosis…Researchers involved in ROSE are using several approaches to study endometriosis. These include efforts to better understand the genetic basis of the disease and relate this what is occurring at the cellular level in the disease, with particular emphasis on the role of stem cells and the immune system.”

What do you have to do?  You sign a consent and answer a few questionnaires.  Once enrolled, you provide a DNA sample either through a mouth swab or a blood sample (if you’re local), provide an authorization to collect tissue samples from your prior/future surgery(ies), and provide a sample of your menstrual blood (this part is totally optional). When I first participated in the study in late 2014, they only used a diva cup for collecting menstrual blood (which, due to my double cervix, I couldn’t do). But now they’ve offered the use of a small sponge to collect menstrual fluid, too. SO I GET TO DO IT NOW! 😀

I’ve also kept in touch with my contact with the ROSE study and sent them the op reports, pathology reports, and photographs from my 2016 and two 2018 surgeries. If you’ve already participated in the ROSE study and have had subsequent surgeries, please feel free to keep them updated!

Also, the folks at ROSE still need the help of parents, siblings, or children of someone who suffers from Endometriosis.  This goes for men and women!  I know I’ve poked my brothers and mum to help with this one!  Please feel free to pass the ROSE Study link on to your immediate family members! They would answer a questionnaire, provide that same mouth swab DNA sample (or a blood sample), and have the option to provide some period blood (well, the ladies would).  I always hear, “I wish there was something I can do to help…” and now they can!

Don’t have Endometriosis?  YOU CAN STILL HELP!  The ROSE study is looking for control groups (aka women without Endometriosis) to compare to those with Endometriosis.  You’d go through the same process:  questionnaire, DNA sample, period sample (again…this last bit is totally up to you).

Reach out to someone on the ROSE team by contacting them:

Telephone: (516) 562-ENDO (3636)

Email: ROSE@northwell.edu

Webpage: https://www.feinsteininstitute.org/rose-research-outsmarts-endometriosis/how-get-involved/

A flyer for the ROSE Study can be read here if you’d like more information: ROSE Endo Flyer 2018_0522

*And if you talk to Margaret, tell her Lisa and Bloomin’ Uterus say hello*

Together we can help push for a better understanding of Endometriosis…and one day: a cure.

Online Research Study: Endometriosis – Emotional & Social Effects

Endometriosis Study for Emotional Issues

I’ve learned of a new study that we EndoWarriors can all pitch in to help. A few students at
Cairnmillar Institute in Melbourne, Australia are working on a study regarding the psychological and social impact of Endometriosis in women 18 years old and older.

This survey should take around 25 minutes to complete.

If you have any questions or concerns, please contact the study authors by email . They’d be happy to answer any questions or provide additional information. And again, if you’d like to answer a few questions, they’d LOVE your participation and help.

Aly Needs Our Help: An Endometriosis Survey

Aly, standing in front of a rock wall

Yesterday we shared Aly’s story with you.  Today, we’d like to share an Endo project that Aly is working on…and she needs our help!

Here’s a quick introduction from Aly regarding her project:

I have been struggling with endometriosis for 7 years now plus 7 other chronic illnesses and I am only 21. I am a graphic design student and for my senior project, I want to create a catalog/brochure that would be available in doctor’s office or clinics to:

  • give patients information about the disease
  • ways to help with the pain and symptoms
  • share stories
  • find support
  • to help bring awareness about endometriosis
  • and a way to let women know they are not alone in the fight.

She has created a survey that she is asking people to take to help her with my research to create a catalog/brochure that people won’t just throw away. She’s also open to suggestions for the content, as well. 

I’ve taken the survey and it took a few minutes and had some valuable questions to answer.

An Endo Study in the UK is Looking for Participants

A fountain pen resting on a page containing the definition of research

Are you a South Asian Muslim woman living in the UK and have you been diagnosed with Endometriosis?  This one is for you!

Shabnam Jheengoor is a student at the University of Derby and she is working on her a research study for her Master’s in Psychology thesis.  Her work is being supervised by Dr. Sophie Williams.

She will be exploring the experiences of endometriosis of South Asian Muslim women in the UK.  Why?  Research suggests that culture/faith can influence one’s experience of living with endometriosis. Little is known about the challenges, concerns, needs, and experiences of South Asian Muslim women in the UK with endometriosis.   Shabman wishes to shed some light on that subject.  And offer these women a voice.

Qualified participants will be expected to take photographs of their daily life of living with endometriosis. The participants will be given 2 weeks to take photographs and the choice of photographs is theirs, following ethical photography guidelines of course.

Their participation will remain confidential and anonymous and is completely voluntary. Participants may also withdraw from the research before, during and after participation.

For more information on the study, please check out the participant form or you may contact Shabnam directly by email.  The recruitment period will close at the end of August 2018.  So, if you are able and interested, please get in touch with Ms. Jheengoor.

Recruitment flyer for endometriosis study

An Endometriosis Study Needs Our Help

Research Outsmarts Endometriosis logo

The ResearchOutSmarts Endometriosis (ROSE) Study has been ongoing for a few years and they still need our help.  They’ve recently received the 2018 Innovation Challenge Award for researching potential diagnostic tests for menstrual effluent (aka period blood) – congratulations you guys!!  I’ve participated in the study and so can you. Yes, you!!  But you must be over the age of 18 and NOT pregnant or breastfeeding.   Don’t live in the New York area and feel like you can’t help in any way? That’s not true!  You can work via e-mail and express mail.

What’s the study all about?  Per their webpage, “The goal of the ROSE study is to investigate the causes of endometriosis and bring improved diagnostics and treatments for women with endometriosis…Researchers involved in ROSE are using several approaches to study endometriosis. These include efforts to better understand the genetic basis of the disease and relate this what is occurring at the cellular level in the disease, with particular emphasis on the role of stem cells and the immune system.”

What do you have to do?  You sign a consent and answer a few questionnaires.  Once enrolled, you provide a DNA sample either through a mouth swab or a blood sample (if you’re local), provide an authorization to collect tissue samples from your prior/future surgery(ies), and provide a sample of your menstrual blood (this part is totally optional).

Also, they’d still like the help of parents, siblings, or children of someone who suffers from Endometriosis.  This goes for men and women!  I know I’ll be poking my brothers and mother for this one!  Please feel free to pass the ROSE Study link on to your immediate family members! They would answer a questionnaire, provide that same mouth swab DNA sample (or a blood sample), and have the option to provide some period blood (well, the ladies would).  I always hear, “I wish there was something I can do to help…” and now they can!

Don’t have Endometriosis?  YOU CAN STILL HELP!  The ROSE study is looking for control groups (aka women without Endometriosis) to compare to those with Endometriosis.  You’d go through the same process:  questionnaire, DNA sample, period sample (again…this last bit is totally up to you).

Reach out to someone on the ROSE team by contacting them:

Telephone: (516) 562-ENDO (3636),  send them an email, visit their webpage, or view their Flyer.

*And if you talk to Margaret, tell her Lisa and Bloomin’ Uterus say hello*

An Update: Endometriosis in Cynomolgus Monkeys

macaca_fascicularis - monkey

Last year I wrote about a study involving Endometriosis being found in Cynomolgus monkeys.  Recently, a new study was published in Human Reproduction about those monkeys and Endometriosis, and here I am to regurgitate it to you in my layman understanding.

At the Tsukuba Primate Research Center in Japan, 614 female cynomolgus monkeys were evaluated between 2008 and 2012.  Of those, 29 were chosen to be screened on a routine basis, including monitoring menstrual cycles, fertility, bloodwork (including CA-125 levels), and physical examinations.  Surgeries were performed and 15 of the 29 monkeys had surgically confirmed cases of Endometriosis.

Let me repeat that:  fifteen of the 29 monkeys had surgically confirmed cases of Endometriosis.  These monkeys were not implanted with Endometriosis as lab rats often are.  It grew on its own.

These 15 monkeys ranged in age from 8 years old to 20 years old.  They discovered that CA-125 levels tended to be elevated in the monkeys that had chocolate cysts present and lower in those who did not have endometriomas.  They also discovered that painful palpation examinations and abnormal feces were both commonalities with these monkeys.  Also of note, the monkeys ate less food during their menstrual cycles, which may be attributed to increased pain and a decreased quality of life.

During the time of the study, the remaining monkeys who did not have Endometriosis were monitored to make sure they did not develop the illness.  Four of them DID develop Endometriosis!

Even though the monkeys were small in comparison to humans, the surgeons were able to easily identify Endometriosis lesions (and their various colors: red, pink, brown,  blue, black or white), endometriomas (chocolate cysts), and adhesions while performing the laparoscopies.

Based on these findings, the authors suggest that screening, diagnosing, and monitoring Endometriosis in monkeys should include palpations, fecal monitoring, and CA-125 testing.

The findings of the study were that cynomolgus monkeys with spontaneous endometriosis may prove to be a good model to evaluate the disease, as well as drug efficacy.  I would hate to think that that means they may one day end up as lab rats for drug companies.  My animal-lovin’ brain takes me down that dark path, though.

I am constantly amazed by the presence of Endometriosis in non-humans.  And saddened at the thought that these animals cannot vocalize the pain I know they feel.  But knowing that the illness affects other species makes me hope that it may one day get the attention of the scientific and medical communities that it deserves.

RESOURCES:

Human Reproduction –  (April 2018) – Spontaneous Endometriosis in Cynomolgus Monkeys as a Clinically Relevant Experiment Model (entire 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