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Clinical Trials for using hormones on young people - contraceptive pill, hormone blockers, growth deficiency etc

(5 Posts)
ITCouldBeWorse Sun 31-Jul-16 10:44:07

I am not looking to start a bun fight - so will state my view on young people gender transitioning up front - I think it Is better to try to change societal stereotypes, than to cut and change healthy bodies.

I know hormones are used for many different purposes, contraception, treating acne, delaying precocious puberty, 'normalising' growth when things go wrong, but I know it is tricky to run clinical trials on young people who cannot necessarily give informed consent.

I also understand that a drug which is licenced for one purpose, cannot be used for another that is unlicensed (I remember a drug that my FIL could not have because it was only licensed to treat arthritis and not cancer at that time).

So when young people have puberty artificially halted, or are given testosterone or oestrogen (I think that's right!), are they tested like any per drug would be? Do they meet NICE guidelines? I thought it took ages to trial properly with sufficient numbers?

I cannot believe this sort of thing would just slip through the net, but equally I don't see people quoting data from reliable trials.

Does anyone know lots about this and could point me in the right direction for info? I fear the sources I have looked at all seem to have agendas - both ways!

BluePitchFork Sun 31-Jul-16 10:51:45

no, those medicines are given 'off label' (not licenced for that use) but often with a wealth of good data behind it. in order for a company to apply for a licence for other indications those dara is needed to prove a) it works b) is safe.
to get around 'off licence' often clinical trials are called do that medicines could be reimbursed or paid for by the health service.

my dc has an 'off label' medicine. it is safe and effective for dc's condition but sadly not authorised in children. nhs will not prescribe so we need a private script. luckily for us the medicine costs pennies.

ITCouldBeWorse Sun 31-Jul-16 10:58:39

Does the individual prescribing doctor decide if the data is good enough then? Not saying it isn't, but I got the impression people were wary of prescribing away from protocols for fear of litigation or repercussions from the nhs etc?

Glad your dc gets what (s)he needs affordably. Do you think it will go on licence in time? Or is the usage too niche for it to be cost-effective if it is an inexpensive drug? Hope I am not prying!

BluePitchFork Sun 31-Jul-16 11:07:52

I hope so, because this medicine has been used for the same indication in adults for decades.

wrt to individual prescribing drs. they talk to each other in their specialities about their experiences. hormone treatment in children has been done for a long time, but mainly for growth issues.

Musicaltheatremum Sun 31-Jul-16 14:10:10

The doctor who prescribes the medication takes the legal responsibility for the prescription. That's why you may find many GPs very sensibly refuse to prescribe some drugs off label as they don't have the in depth knowledge that the specialists do to prescribe.

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