IUD required for new Vertex study

[ToriMom]

This is mostly a vent...
I have been trying to get my daughter into a clinical trial for one of the CFTR modulators for a while. For different reasons she hasn't been eligible--wrong mutations, too young, etc. Well, yesterday I contacted a few centers around the country about the Vertex 440-101 study. It seemed like it would be a possible match for her, and I was excited! Well, one of the coordinators emailed me back to say that the FDA is requiring all childbearing aged females to have an IUD contraceptive device in place in order to participate. The birth control pill is not allowed as an alternative. The study is for people 12 years and older, and my daughter is fifteen. My thoughts were that this would decrease the likelihood of female participants in these studies. I know the protocol is in place for safety, and I'm not blaming anyone for these rules. I'm simply disappointed that she can't enroll due to this new protocol. Have any females on the forum been required to have an IUD before? Like I said...Just a vent because I was pretty excited about the possibility of being in this study.
Still hoping,
Michelle

 

[Rebjane]

I hear your frustration. I find this information disheartening. What if your daughter is completely not sexually active? i would ask more questions. What kind of birth control is required of the boys in the study?

 

[triples15]

Wow. While I can understand the reason behind it, I find this to just SUCK. Pardon my language.

I agree that for some women/girls this will be prohibitive. I am currently in the Vertex 770/661 trial and am on oral contraceptives. I've not heard mention of an IUD. I have a study visit next week and intent to talk to coordinator about the upcoming triple combo studies. I'll ask about the IUD and will be curious to see if that will be required if I roll into the next study. I will have a tough decision to make if it is. I have had all kinds of gynecological problems, including two procedures to remove precancerous cells, too many biopsies to count, and a surgery to repair a septate uterus. I have ZERO interest in "messing with" anything in that department again. :/ I guess I'd have to talk to my OB/Gyn and get her thoughts.

While generally speaking they are pretty safe, IUDs are not without risk. The main one being that they can embed and even perforate the uterus, requiring surgery. If it goes unnoticed it can go to other parts of the body, causing more harm. They can also fall out (expulsion), unbeknownst to the woman, sometimes resulting in pregnancy. I actually had a close friend who got pregnant with an IUD in place. That said, obviously I know women get pregnant on the pill as well.

Anyway, like I said I understand it, but I don't like it. I'm sorry that you will have to make that decision for your daughter. I'm guessing this decision to change policy must have something to do with women becoming pregnant during Vertex trials. Apparently, according to posts on FB, there have been lots of instances.

Well I've gotta run but thanks for the info. I'll ask about it at my visit next week.

Take care,

Autumn

 

[ToriMom]

Hello Friends!
So I did find out from a second center in another state that the IUD is what they will be requiring for any menstruating females. At least, that is the current plan for the triple combos. Even if you are not sexually active AT ALL--it's required. Probably on the slim chance of a sexual assault during participation. I'm not sure why birth control pills are not enough, but I assume it is because people might forget to take their contraceptive. Here is the wording on Clinical trials.gov:

To prevent pregnancy, female participants of childbearing potential and their male partners will be required to use pre-specified, highly effective methods of non-hormonal contraception. Male participants with female partners of childbearing potential will be required to use a condom.

So I suppose men can participate if they say they will use condoms. It's not very fair, but with CF so many things are not fair that I've pretty much stopped expecting fairness. I'm just not sure I would put my sexually abstinent daughter through an IUD placement. I would need more encouraging information to make that choice.
Autumn--maybe they will "grandfather" you into the next phase. Please do update us on what you hear from your clinic.
Thanks

 

[jricci]

How frustrated you must feel! I remember how disappointed you were when the 661 study fell through for her and now this. It's so difficult when we get our hopes up about somethong only to have them dashed.
I think the reason for the IUD is because VX-440 was associated with teratogenicity risks in a preclinical study. And with the knowledge that Orkambi may lower the effectiveness of hormonal birth control, they’re probably taking extra precautions in case this drug also lowers effectiveness of birth control.

If you do decide to find out more about the IUD, try to find a GYN that specializes in adolescents. My daughter’s friend, who is also 15, is having some GYN issues and her mom took her to a GYN that specialized in adolescents. She said that it was obvious that the doctor had a lot of experience in working with teenagers and that she patiently addressed all of their concerns. The GYN said that if further testing indicated that her daughter needed to have a pelvic exam that she would suggest sedation during the exam to prevent any type of psycological trauma since her daughter was so upset and scared with the thought of one. So if you do decide to go this route, maybe you could find someone that would be willing to sedate her during the procedure.

I’ve had an IUD for 12 years. I haven’t had any issues with it. The procedure itself is done in minutes and was slightly painful for me. I had some cramping and bloating for a few days after. I’m not trying to sway you towards the IUD choice. But I wanted to give you more information as you make your decision. I have a 15 yo daughter and know that I’d have a very tough time deciding what to do.
Also wanted to mention that I’ll fix the information on the thread I created about this study back in November. I copy and pasted the information from the CFF website when this study was first announced, but I guess they changed the inclusion criteria from 18 years old to 12?

 

[kenna2]

I'm sorry this is frustrating. While I don't have an IDU and do not take oral birth control (due to absorption issues I use NuvaRing), I might have an idea why this is being required. With the risk of CF patients not being able to absorb things well and the earlier studies shown that these types of meds render oral birth control ineffective, there is no data about other forms of birth control being used to see how they react with these meds. I think it might be possible that a non-oral type of birth control might be the new norm or recommendation for females with CF. It makes sense, if we can't absorb things normally, why rely on a from of birth control that you have to absorb to work? Just my thoughts

 

[ToriMom]

Thanks for the kind words everyone! Jricci--the coordinator said phase one is for 18 years and up--the next phase is for 12 and up. It's good to hear that you haven't had any issues with the IUD, and that you have had one for a while. What you (and kenna2) wrote about the lowered effectiveness of hormonal contraception clarifies the reasoning for me!

Thanks for that information. I sure love this forum.
Hugs

 

[jaimers]

one more thing to note is that it has to be a copper IUD. It can't be one of the hormone releasing IUDs. You also have to have it in place for at least 90 days prior to starting the study. i understand their concerns but I'd be curious about the birth control requirements for men as well. It seems if it's a young woman that's not sexually active at all that there would be some flexibility in the IUD requirement.

 

[kenna2]

There wouldn't be any birth control requirements for men as there is no oral birth control for men therefore nothing their bodies have to process. There isn't any drug interaction going on.

 

[jaimers]

But if male participants are sexually active and their partner became pregnant couldn't the baby theoretically be affected in some way by the father being on the trial medication? Maybe not....

 

[Imogene]

Need to let you know on the Clinical Trial front...that this week Feb 21 and 22, I was a presenter at the Data and Technology Clinical Trials Summit in Philadelphia.
I was invited to speak because I am a founding member of the Aurora Project for pharmaceutical companies with the mission of having pharmaceutical companies becoming more patient centric.

The first part of the Summit was heavy with Pharmaceutical companies presenting all the new and exciting ways to deal with data for clinical trials. The data is always de identified and it is amazing all the different ways data is manipulated in clinical trials.

Data is of course the treasure for research...you, participating in clinical trials "give away" your data in the hopes of a cure for the disease. But the data for cystic fibrosis mutations is VERY VALUABLE...as you witness the CFF with 3 billion dollars and Vertex valued at 5 billion dollars based on drugs for cystic fibrosis.

I presented with Patrick Merel, ...because our new CF APP solution for this community is revolutionary and simple


Because the whole summit was about clinical trials...KNOW that I did read from this thread...hoping to receive an answer to Michelle's original question...why does a 12 year old need an IUD to be included in the clinical trial?
This was a breathtaking moment in the clinic...one pharma rep who answered told me she had goosebumps...and her solution to the group was:

something along these lines: "Perhaps we need to look carefully at those who don't quite qualify for trials...they could be in a category by themselves and have the drug available (I am not sure at what point?).... The man from the Pfizer group sat with me a lunch and mentioned that clinical trials for breast cancer never include men...even though men with breast cancer benefit from the same drugs as women with breast cancer
But KNOW you make a difference as I figure out my own role in the Aurora project...and especially as we move forward with our app.
which was revolutionary at the summit!
You have the pharmas attention and they are thinking!
Wonder how it is going for you, Michelle and your daughter.

Salt and Light,
Imogene

 

[chicagocubsmom]

The only reason I can think of that a study would require a copper-only (non hormonal) IUD is to eliminate any hormone interactions with the medication they are testing. And there is some evidence out there that hormones play a role in CF (studies showing that women have a shorter life expectancy).

That said, I would caution a teenager on getting a Paraguard copper IUD. I have one now and it's my only option because I can't be on hormonal birth control. I'm MISERABLE on it. Periods are ridiculously heavy and come every three weeks. I've also gained weight on it. As a mom I can handle it and work around it. As a teenager I would be freaked out and find it hard to do sports and extra curricular activities with the care I have to take. I've had it for two years and there has been no abatement in the side effects. That said, it can always be removed if your daughter really wants to do the study!

 

[ToriMom]

Imogene--wow and super WOW--I think it's incredible that you have these connnections with medical personnel and pharmaceutical companies. Thank you so much for putting my concerns out there so the people creating these clinical trials get a clearer understanding of the patients' point of view. I'm so happy to have someone speak and advocate on our behalf! You asked how Victoria is doing--overall pretty good! We have discussed the IUD more, and I think that for now we will not participate in the studies requiring the IUD. We spoke with her pulmonologist who said he is happy with her "moderate" lung disease at nearly 16 years old. As a mom I want her to have the BEST medicine out there, but I think patience is wise in this case. We did order her a VibraLung to try another airway clearance system. We are also taking Indrepta every day now. Hopefully we will see some improvement in her energy soon.
With infinite gratitude,
Michelle