Sage 217 clinical trials started


#1

Sage is now recruiting for the clinical trial testing out sage 217. Go to clinicaltrials.gov and search for sage in your city (or nearest big city) to find locations where they are conducting the trials. This is the oral form of Allopregnanolone which according to Melcangi is a major component of PFS. Apparently the oral form of this medication is supposed to improve depression symptomatology within 2 weeks. In addition, studies have shown that Allopregnanolone plays a large role in sexuality.


#2

Have you signed up, @dgreene?


#3

Looks like the eligible participants are those with types 1/2 bipolar, major depression, and insomnia.

You do not need all three of the above to be a participant.


#4

Wish I was American, everyone should do what they gotta do to get in on this


#5

Yes I am trying to sign up. I am currently very busy with my job, but hopefully I can get started within the month. Everyone here should try to get involved, this is the biggest hope we’ve had for years. I’m surprised more people are not commenting.


#6

…It would suck to be placed in the placebo group though…

I checked the locations of the clinical studies and there is nothing remotely near me.

EDIT: Full list of investigational sites here: https://clinicaltrials.gov/ct2/show/study/NCT03672175?term=sage-217&rank=7&show_locs=Y#locn


#7

Everyone who enrolls should post here so we can keep a log of people’s experiences with Allopregnanolone.


#8

They’re doing a 1:1:1 ratio of 30 mg, 20 mg, and placebo - so a good 67% chance you’ll get some dosage if you sign up ;).

I think this would be very enlightening if some people on this forum could get in their trial and share their experience.

They actually dosed the first patient on December 7 but now they’re advertising the trial now, it seems. Good news that they still appear to be on target of completing their trial by Nov 2019.


#9

In the UK but this brings hope for us all


#10

here is the link they sent me for the trial sign up if anyone else is interested


#11

If they ask you to name any existing conditions, what will you say?


#12

Depression and anxiety. The medical world doesn’t even acknowledge PFS anyway so what’s the point in mentioning a pre-existing medical condition that they don’t think exists?


#13

Wouldn’t say that you have “post-finasteride syndrome”.

Just say typical depression and no suicidal thoughts/episodes :slight_smile:


#14

Update… I urge anyone else that is willing to try to participate as well as its unclear if they’ll have a site for me yet. Witchita Falls is a 5 hour drive for me so that’s undoable.


#15

Just in case people have not picked up on it.

If you’re locating in the U.S., here’s the website where you can potentially qualify for the phase 3 sage-217 trial:

Hoping to hear some feedback of members who qualify (I’m unfortunately from Canada!).


#16

Replacement of Allopregnanolone with a synthetic hormone may lead to a suppression of the natural hormone. The body will detect the synthetic version then may decide after a period of 14 days that there is enough of the hormone within the body and thus stops natural production. Therefore cycling the drug for 14 days then coming off maybe a way to minimize the risk of damaging natural production assuming what I write is correct. So this drug may only provide a short term solution via cycling but still it should improve the patients quality of life during treatment.

With anabolic steriods a 6 month shut down of natural production is enough to damage the HPTA and result in lower levels of natural testosterone being produced on a permanent basis. The longer our natural production is shut down the greater the risk to natural secretion within the body. There is no guarantee that the body will accept a synthetic version over a long period of time. TRT patients have sometimes found testosterone treatments have started to fail after many years of use and require a long period off the medication.

We also don’t know how PFS will react if Allopregnanolone is introduced to the body at normal levels or what will happen to PFS if we come off synthetic Allopregnanolone. Then there will be a period of low natural production as the body restarts secretion.

The hormone system is a carefully balanced orchestra :slight_smile: we don’t know what affect a synthetic version will have on other hormones or functions of the body. An example would be how synthetic testosterone can thicken the blood and increase risk of a clot formation. An Endocrinologist would probably have a better idea as to the suitability of this medication over a long period and the potential side affects to natural production. If anyone here is visiting an Endo it might be worth asking during the consultation what their Drs thoughts are on synthetic Allopregnanolone.


#17

lol I’ve been to three of the supposedly “highest rated” endocrinologists in my metropolitan area and they all told me there isn’t even a blood test for DHT ffs. Would love to hear their thoughts on synthetic Allopregnanolone…


#18

It’s almost funny that “high rated” endos wouldn’t even be bothered to look it up.

As far as an exogenous allopregnenolone analogue shutting down natural production, I’ve never heard of a feedback mechanism involving allopregnenolone, but haven’t been bothered to look into it. It would be a shame if this works but leads to dependency. Still better than if it doesn’t work.


#19

source?


#20

Thanks Dubya. It’s worth raising these concerns, if we fail to prepare were prepared to fail :slight_smile: trusting a pharmaceutical company is what brought us here in the first place. A treatment that leads to dependency would be a shame like you said. Lets see if someone can clear this up on their next visit to an Endo.