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

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