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

ABC 10 News Interviewed Local EndoWarriors About Lupron Depot

Stillframe from ABC10 story about San Diego Endosisters who speak about about Lupron Depot

Jennifer Kastner of ABC 10 News San Diego reached out to Bloomin’ Uterus to see if we had any of our local Endo Warriors that had treated with Lupron Depot. Several of us had and jumped at the chance to share our experiences on the drug.

Five EndoSisters, Jennifer, and her cameraman Adam met for a two-hour interview one afternoon early this year. It was an incredible experience. We each had the opportunity to share our Endometriosis stories and our experiences on Lupron Depot.

One Sister has chosen not to take Lupron and talked about her battle with physicians to respect that decision.

The 2-hour Q&A session was paired down to a 5-minute investigative report. Jennifer did a wonderful job of fitting in a bit of our stories, as well as covering the side effects of Lupron, and the havoc it can cause.

If you’d like to watch the interview and read the more in-depth written report, please check out ABC 10 News’ page.

I’m grateful to Jennifer and Adam for reaching out to us and dedicating their afternoon to our interviews and for their weeks of investigative research. And I’m so proud of, and equally grateful to, our EndoWarriors who were able to join me that day: Melinda, Amanda, Brooklyn, and Linda – I love you. And am so pleased that you’re a part of my life.

Thank you for all that you do. Together we can achieve great things!

Feel Good Fridays

The sun beaming through clouds at twilight

It’s the end of the week already?!?

So, bringing you a reason to laugh:

“Laughter is magic that dispenses clouds and creates sunshine in the soul.” 
― Richelle E. GoodrichSmile Anyway

If you’re down in the depths, try to find something to make you smile. A memory, a thought, a thing, a book, a quote, a TV show, a friend, a pet, a game, or even sleep and find it in a dream.

May you find peace.

Blogs I updated this week:

C-Sections & Endometriosis:  added a March 2018 study published in the  International Journal of Reproduction, Contraception, Obstetrics & Gynecology of a woman who had a large purple lump on her c-section scar that oozed greenish fluid during her periods.  Any guesses as to the diagnosis?

Endometriosis & the Lungs: added a March 2018 study of a woman with a collapsed lung and the positive biopsy results for Endometriosis found in the pleural cavity.

Lupron Depot: My Experience:  added an update as to how I’m doing three years later, as well as a 2018 study of long-term effects of Lupron Depot use, published in the Journal of Pediatric & Adolescent Gynecology

Natural Products I’ve Fallen in Love With: added Truth Serum deodorant made by Lucky AF Club.

Cataract Surgery has been Scheduled!

20170829_134901
Gigantic dilated eyes are the window to the soul?

Okay! Here we go!

Today I met with my ophthalmologist and we talked about my eyeballs.  I learned quite a few things today.

He confirmed that I do have two cataracts in my left eye.  The first is a benign congenital cataract. One that I was born with.  He cannot say if it has or hasn’t grown over my 38 years ’cause he didn’t know me when I was born, but it’s small and out of the way 😉  He did confirm it’s there and it’s sounds to be in the same spot it was when I learned about it 15 years ago.

The second cataract is the booger that’s been causing my vision to blur and see double.  And continue to worsen and grow.  My right eye is 20/20 and my left eye is 20/50…So my choices are: leave it alone and let it worsen and eventually have it surgically removed at some point…or don’t wait and have it surgically removed now.

I’m a gal of action, so … surgery has been scheduled! October 2!

I ALSO learned that my left eye is slightly lazy.  Whua? He thinks that likely my left eye may have developed differently than my right eye because of my premature birth.  I’m 38 years old. You think eye exams every two years of my adult life (and however many I had as a child) – someone would have said something at some point?  Nah.  Ha!

What does the lazy eye mean? Not much. My left eye is slightly off center; I may have some trouble with my left and right eye focusing together, my left eye may have to work a bit harder, etc.  But it doesn’t mean much.  It’s only a little lazy. 😉  When you Google it, it’s something something something brain gave more focus power to the good eye blah blah blah.

Anyway, I’m uber excited about  my upcoming cataract surgery.  I’m not expecting miracles, but I am expecting to be able to see slightly better than I can now.  And that’s exciting.

My doctor/surgeon is an incredible man who explains things in awesome layman terms, has a great sense of humor, and I immediately trusted him.  We discussed options regarding surgical techniques and lense replacements and I feel we chose the best option for my eyeball, my age, and my budget.

I’m going with the standard surgery and a standard monofocal lens (aka; what the insurance covers!).  My understanding from the consult: using a blade, my surgeon will slit open my eyeball, peel open the “envelope” (as he put it), and break my cataract into pieces using an ultrasound thingymobopper, then they suck out the broken bits.  Then they’ll pop in a lens and *presto* – done.  His hopes are that my vision will be restored to what it was when I was a 10-year-old kiddo.  Wouldn’t that be nice?  I’d be happy if it were just restored to what it was before 2015. Ha!  Other options were a laser-assisted surgery (instead of a blade) and fancy replacement lenses that do a lot of things my eyeballs won’t need.

I’ve no real fears for October.  In, out, and back to work the next day.  So, I’ve called my insurance and *hopefully* figured out all of the co-pays…this will hopefully cost me no more than $700 out of pocket (funny; making it more expensive than my last excision surgery…)!

The bonus?  My Mum may be able to come out and be with me for my surgery! ❤

BUT…what does this have to do with Endometriosis? Why am I sharing my non-Endo related news on my blog?  First off, ’cause I can. Haha.  And it’s an important piece of my life and I wanted to share it with you.  Secondly, IT *is* Endo related:

  1.  While the assistant was taking down all of my pertinent info and health history, we talked about Endometriosis.  She has a few friends who have the disease, so I gave her my little Bloomin’ Uterus cards and invited her friends to join us for our support group meetings or just to reach out and talk.  Every chance you get, talk about the illness – you NEVER know whose life you’re affecting.
  2. My doctor today mentioned that because I was born premature with a congenital cataract, it was very likely that my susceptibility to developing cataracts was higher than the Average Person.  Combine that with six months of Lupron Depot (which some studies have shown may cause cataracts) and *poof* I believe I have my cause.  Although there’s no way to truly ever know.

I hope that you’re all doing well.  If you’ve followed my blog since last week and my incredibly painful days, please know that I am doing well once more.  The pain has ceased (well, the backaches are still there, but meh…they’re not too bad). I’m still bleeding (yay period), but the pain is gone.  And that’s a good thing.

I have a consultation with my gyno/surgeon in late September to discuss “options.”  Brace yourself.

I hope your’e doing well!!  Much love to you.

 

 

Lupron Depot: Q&A

Q&A

As many of you know, I was on Lupron Depot for six months for my Endometriosis.  I wrote about my personal experiences here and also how my life had changed after my last injection (you can read that, and other’s experiences, here).

Recently, a friend of mine learned he will be starting Lupron Depot to treat his prostate cancer.  My husband was surprised this morning when I told him.  He didn’t realize the drug’s original purpose was to treat cancer…in men!  And it’s because of the connection with cancer that many people think Lupron Depot is chemotherapy.  It isn’t.

So, today’s blog entry is here to accomplish a few things:

  1. Discuss the origins and history of Lupron Depot;
  2. How it morphed from a cancer treatment to a treatment for hormonal issues (such as Endometriosis, fibroids, and central precocious puberty); and,
  3. Clarify why I think Lupron Depot is not considered chemotherapy.

I am in no way encouraging or discouraging the use of Lupron Depot in your treatment regimen.  This will not be a commentary piece about the pros & cons of the drug.  The decision is yours.  Research the drug, the side effects, and have lengthy discussions with your physician.

Let the research begin!!

What is Lupron Depot?  In a nutshell, it’s a drug delivered by injection that shuts off your hormones.  In men, testosterone; in women, estrogen.  It’s not an easy treatment to endure, that’s for sure…but every person is different in how their body reacts to the drug.

When was Lupron Depot created?

In 1977, two companies, Takeda (Japan) and Abbott Laboratories (USA), came together and formed TAP Pharmaceuticals, Inc.

In 1985, Lupron Depot was approved for the American market to treat prostate cancer.  Over the years, label improvements, dosage changes, and  better syringes were approved by the FDA.

In 2008, Takeda and Abbott ended their joint venture of TAP Pharmaceuticals.  Abbott Laboratories retained “the Lupron franchise.”

In 2013, AbbVie emerged from Abbott Laboratories and took over the manufacture and distribution of Lupron Depot.

When was it approved for prostate cancer treatment?

In 1985, Lupron Depot was approved to treat prostate cancer.

If it’s not chemotherapy, what is it?

I’ve talked to nurses and doctors about this question multiple times.  I’ve done research.  And I am strongly opinionated on the subject.

It’s a hormone therapy drug.  It works with the pituitary gland and shuts down the body’s ability to produce testosterone or estrogen.  That suppression, in theory, gives the body a fighting chance at beating the cancer because those cells are no longer being fed the hormone it desires so badly to grow.  Lupron Depot does nothing to physically attack cancer.  It simply alters the body’s ability to create hormones that may feed cancer cells.  This starvation effect can either slow or shrink the cancerous growths.

It is not chemotherapy.  I repeat: it is not chemotherapy.

Chemotherapy medications attack the cancer cells directly.  Lupron Depot is a supportive medication that may starve the cancer cells.  It’s like comparing apples and oranges.

When was it approved for Endometriosis treatment?

The best I can find, Lupron Depot was approved by the FDA in 1990 for treating Endometriosis.

When was it approved for Central Precocious Puberty?

In 1993, Lupron Depot-PED was approved by the FDA to treat a childhood hormonal imbalance called Central Precocious Puberty.  What’s CPP?  It’s when children who are younger than 8 or 9 years old (depending on their sex) show signs of puberty and sexual maturity.  Lupron Depot suppresses the hormones, thus suppressing the pace of puberty.

[I know I said I would keep the commentary to myself, but I have to voice this one: I could not even imagine a child going through the side effects I went through…breaks my heart.]

There!  I’ve accomplished what I set out to do today.  *whew* If you’re reading this and I got my dates wrong, please feel free to correct me.  If you’d like to express how Lupron Depot has affected YOUR life, please do so by clicking here.

Resources:

AbbVie.com

Chemocare.com

Chemotherapy.com

Crunchbase.com

CVS.com

Endofacts.com

FDA (1993)

FDA (1995)

FDA (1998)

FDA (2001)

Genetics Home Research

Gregthatcher.com

Lupron.com

LupronPED.com

LupronProstateCancer.com

LupronProstateCancer.com – timeline video

LupronVictimsHub.com

Takeda.com

~ 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

 

Share Your Story: Sandy

Watermelon with some flesh scooped out by a melon baller

Sandy has questions for our readers!  Sandy was 33 when she was diagnosed with Endometriosis.  Now 39, her pain has returned and she needs our help!

“Hi, I have posted before IDK name maybe Buffie1313. Anyway about 6 years ago I did get the shots that put you through menopause. I have struggled with my weight ever since. I did get the perfect wavy curly hair I always dreamed of. I noticed a few months ago my curls looked as if they where going bye bye. They pretty much are now. I have been able to start losing weight. And….my endo is back!!! The shots took close to 6 years to go away. I am getting the stabbing pain on my right lower abdomen, I always got it there. Now on my far left abdomen like hip bone or pelvic bone. My endo was not just before my period. It was all the time maybe with a few day break. I really feel like it is coming back with vengeance. I hurt through out my day off and on every day. When I am being active I feel like I am being stabbed on both points I said above left hip pelvis can be all day. I am feeling the pressure pain and stabs down in our lady area and other area down in that area. I refuse to do shot ever again!! To be really honest I am scared. Before sex started hurting. I had so much pressure pain down there the slightest extra pressure from sex was tearful. I have a long way to go for real life menopause to end this for good. What have you all tried that helps with this? FYI I am already on hydrocodone for neck problems..Thank God can you imagine how much worse this pain would be? But, never the less I have the stabbing, the feeling someone is taking a melon ball scooper to my insides. Any advice?”

Please feel free to email Sandy.  She’d love to hear your advice.

An alternative to Lupron Depot, Letrozole, or Danazol?

Needle for Lupron Depot injection

The Journal of Restorative Medicine has published an article by Dr. Edward Lichen in their December 2016 compilation about non-surgical treatment of Endometriosis.  You can read the article, in it’s entirety, by clicking on the link under “Resources,” but I wanted to give a brief overview of my interpretation:

Causation:

  • Causation continues to be a mystery.  An overview of the nine theories of causation is given.
  • DNA research is ongoing.
  • Estrogen plays a role.  Many women with Endometriosis cannot opt for estrogen replacement therapy (even if post-menopausal) due to high recurrence rates of estrogen stimulation.
  • Xenoestrogens, dioxins, and endocrine disruptors increase inflammation and can cause Endometriosis to develop/recur.

Recurrence After Surgery:

  • There’s a 10% recurrence rate in less-severe Endometriosis.
  • There’s a 62% recurrence rate in women with severe Endometriosis who still have their ovaries.  Keeping the ovaries may lead to a 6 times greater risk of recurrent pain and an 8 times greater risk of recurrent surgery.
  • 20%-40% of women who have had surgery continue to suffer from residual pain.
  • 3.7% of women who undergo a hysterectomy and/or oophorectomy have have a recurrence of Endometriosis.

Drugs:

  • The ideal pharmaceutical treatment of Endometriosis has yet to be developed.
  • Lupron Depot, and other similar GnRH agonists, continue to remain the preferred method of symptom suppression, regardless of the side effects.
  • Aromatase inhibotors, such as Letrozole, also have similar side effects and symptom relief as Lupron Depot.
  • Danazol, a synthetic steroid, is the only alternative to GnRH agonists which offers similar symptom relief with fewer side effects.
  • The use of add-back estrogen sometimes offers little relief from the side effects.
  • Failure of these treatments often leads to surgery, hysterectomies, and oophorectomies.
  • A drug combination of anabolic steroids, Nandrolone and Stanozolol, shows similar symptom suppression without the side effects of Lupron Depot or Danazol.  A case study of one woman treating with both drugs has had symptom suppression and very few side effects over an eight-year period. (See US Doctor abstract under Resources).

What will you do with this new information?  I may talk to my doctor about the steroids combo if my pain returns full-force…but only after doing my own research about the side effects one can expect from that cocktail!

(Updated March 27, 2019)

Resources:

Journal of Restorative Medicine – (Article; Dec. 2016) Paradigm Shift: The Realization of New Medical Alternatives to Surgery for Endometriosis

US Doctor – (Poster; 2014) Novel Medical Endometriosis Protocol Offers Alternative to TAH BSO and Hemicolectomy in Confirmed Stage IV Disease

~ 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

Share Your Story : Terry

lupron

Today’s story is a bit different.  Meet, Terry, a 72-year-old man from California.  Terry was diagnosed with prostate cancer and was prescribed Lupron Depot as part of his treatment.  He would like to share his experience with us today, as well as pose a question to all of you:

*

I had prostate cancer and opted for the radiation (43 days) and Lupron Injections for two years – every six months. I was able to withstand the first two injections but the side effects were so bad, I told the doctor to discontinue.

I was due for my third injection on June 15th, 2016 – its now August 6th and I still have side effects. At the height of my pain, there were hot flashes, joint pain in hips, knees, feet, chills, fatigue, burning urine, loose bowels, and would get up 10 times at night. Some of the side effects have decreased, however, the fatigue is extreme. Still having to go to the bathroom all through the night and loose bowels.

The doctors never mentioned any of the less common side effects. Hopefully, it gets better?

*

If YOU would like to give Terry some encouragement and discuss your side effects and how long they took to dissipate (assuming they have), please email him here.  He would love some hope and encouragement.  And I know so many of you who offer hope and encouragement.

And if you would like to share your story, click here.

Questions re: Hormone Therapy & Endo

For those of you who have Endometriosis or know someone who does, Bloomin’ Uterus and The Pharmacists Clinic will be hosting a workshop about hormonal therapy and Endometriosis on August 31st. Even if you cannot attend the event : If you have questions about any hormonal therapy, whether it be birth control pills, IUDs, implants, Lupron Depot, Letrozole, Depo Provera, or others, please feel free to email Dr. Raffie at drrafie@pharmacistsclinic.com. She will do her best to address the question in the presentation. We’ll be taking detailed notes and will write a post-event summary, too. And if you’re in the San Diego area and are interested in attending the event, let me know. I can send you more info.