In early November I became an active participant in a blind trial for a medication. The medication was already approved by the Food and Drug Administration for other medical conditions. Personally, I was part of the trial to see if the medication could/would benefit those with Endometriosis, like myself. I went in and met with the trial team, for almost four hours they asked questions and performed various tests. I was instructed as to how to take the medication, twice a week, leaving 3 days between each dose. I did not know if I was on the placebo or the actual drug they were studying. It quickly became evident that I was on the medication due to the side effects I was enduring.
I started retaining water, having a hard time sleeping, hot flashes, constipation that left me almost septic at the end. I reached out to the medical team letting them know my struggles and concerns, especially because while I was struggling daily due to the symptoms, my endometriosis pain had significantly decreased. They will not confirm or deny which pill I was taking, however, after a visit with my specialist I am confident that I was in fact on the medication. I was frustrated at the lack of empathy, sympathy, understanding, or concern from the trial team. Until I remembered, I was a guinea pig, a number, a statistic, I was not a patient or a "human" so to speak.
I made the decision after weeks of making lists of pros and cons to come off the medication, bowing out of the study. As I detox off the medication, that happens to have a long half-life, I am also visited with endometriosis pain, and it's back with vengeance. Of course I am disappointed that my body didn't react well to the drug, especially where I seemed to be getting relief. I am however, not sorry that I tried something different, that I stepped out of my comfort zone knowing that medications and I have a history of not playing nice with one another. I took a chance, and as I said upon being picked for the study, it helped me find hope. Hope that the medication may be approved and help other women struggling with endometriosis, hope that there one day be a medication option than helps women live a more normal life with this disease. There is also hope that something else will come along, and perhaps another study will come along that I can be successful in. I was told after my last surgery to hurry up and have kids and to consider a hysterectomy, by a physician who I no longer see. She stole my hope temporally, my new provider along with the team conducting the study gave me hope. They were not neglecting me they were collecting data. The data the collected from me will show that yes, there is relief, or there can be. It will also show potential side effects and help those in the future, should the medication be approved, know what to look for, what they may or may not struggle with. Hope. I still have hope, even as a guinea pig who was not successful with this particular medication trial.
While I initially started the trial for myself, with the hopes of relief, I realize now that it was about something much bigger. The potential to help so many others. Prior to my initial appointment I came up with a list of questions to ask those running the trial. It was as follows:
Are the medications/placebos gluten free and celiac safe?
What is the protocol?
What, if any are the most common side effects?
What studies have been completed on this medication thus far?
Has anyone had positive effects at this point?
How do you think I might benefit from joining this clinical trial?
Why is this specific approach being studied?
What are the eligibility criteria to enroll in this study?
Am I eligible for this clinical trial? If not, can you recommend other options?
Why are you recommending this specific clinical trial for me?
What happens if it works, and the trial ends? Can it be prescribed?
How will I know if it interferes with my other medications?
What if I have a bad reaction and need to stop the study?
Am I eligible for other studies if this one doesn't work out for me?
What is expected of me as a participant?
How long will the trial last?
What is the purpose of the study?Have similar studies already been done and what were the results?
How will my medical information and privacy be protected?
Ask the questions, get the answers, and if something else comes to mind, ask that too. You can never ask too many questions, you can never have enough information. This experience was an emotional roller coaster due to everything that led to it, however, I am grateful for the opportunity, and carry hope with me always.