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[suzysunday]

Just worried about womb linings at time. My mind jumps from one worry to another. No wonder I'm exhausted!

[CLKD]

It's awful.  When my brain was in over-drive I couldn't remember what was coursing through it, DH asked me once and I couldn't tell him so he was unable to help 

[dangermouse]

As well as many ladies having bad reactions to progesterone 

I suspect progesterone intolerance is actually ‘Utrogestan intolerance' so more about dosage. No one seems to have trouble with other natural progesterones.

[Conolly]

I agree, I didn't have any problems on 50 mg compounded progesterone but felt suicidal on 100 mg Utrogestan.

I was wondering why there are no long term studies on Vagifem which has been on the market since 1995!

Conolly X

[CLKD]

In what way 'long term studies'?   Often users of medications simply aren't asked how they get on with a product by anyone other than their GP and apparently there is a yellow card system to report to the Manufacturers but one has never been offered to me 

[suzysunday]

You can report on the yellow card scheme about drugs through the yellow card website or by post if you have bad reactions to drugs.  Most people maybe don't bother or know about it if they don't read the leaflet that comes with medication.

[CLKD]

Having read the leaflets none mention the yellow card.

How R we all this morning?

[Jenna]

Having read the leaflets none mention the yellow card.

Here you are CLKD:

https://yellowcard.mhra.gov.uk

[CLKD]

 

[suzysunday]

Yes ckld, I've looked at a leaflet I have for ovestin and it doesn't mention the Yellow card, though I have seen it on other leaflets.  It should be on all medication really.

[Hurdity]

I agree, I didn't have any problems on 50 mg compounded progesterone but felt suicidal on 100 mg Utrogestan.

I was wondering why there are no long term studies on Vagifem which has been on the market since 1995!

Conolly X

In what way 'long term studies'?   Often users of medications simply aren't asked how they get on with a product by anyone other than their GP and apparently there is a yellow card system to report to the Manufacturers but one has never been offered to me 

Long term studies are not usually carried out to see if there are side effects as such - these would normally be determined at the testing stage (which might be long term depending on the product!), so that is where the yellow card scheme comes in.

They would be carried out if appropriate to determine the long term efficacy or particularly safety of a treatment.

In the case of Vagifem - I imagine it just is not cost-effective due to the extremely low risk of harms, due to the very low dose.  The effect of systemic oestrogen on the uterus has been much studied and the dose dependent nature quantified.  I don't have any of the studies to hand - but just to repeat suzysunday - these have been extensively examined by the medical researchers and professionals to come to their informed conclusion that endometrial hyperplasia and thereafter potentially cancer would be extremely rare and therefore not justifying adding a progestogen routinely nor regular endometrial scanning either.

(As an aside, even the very low dose oestrogen patch available in US (approx 14 mcg ie 14 mcg per day delivery) - the Menostar - is prescribed without a progestogen although endometrial thickening is expected as one of the side effects).

Relax suzysunday - but of course always be vigilant.....

Hurdity x

[suzysunday]

Many thanks for that.  I feel re assured and yes I will stop worrying.

[Conolly]

Hello again,

Long term studies are not usually carried out to see if there are side effects as such - these would normally be determined at the testing stage (which might be long term depending on the product!), so that is where the yellow card scheme comes in.

Long term studies should be carried out, considering that all testing stage studies for topical oestrogen were restricted to 12 months and the drugs (estradiol and estriol) were supposed to be used for the shortest time necessary to relieve symptoms, which unfortunately has not turned out to be the case for vaginal atrophy, widely recognised as a long term (if not lifetime) condition.

They would be carried out if appropriate to determine the long term efficacy or particularly safety of a treatment.

What does 'if appropriate' means?

In the case of Vagifem - I imagine it just is not cost-effective due to the extremely low risk of harms, due to the very low dose.  The effect of systemic oestrogen on the uterus has been much studied and the dose dependent nature quantified.  I don't have any of the studies to hand - but just to repeat suzysunday - these have been extensively examined by the medical researchers and professionals to come to their informed conclusion that endometrial hyperplasia and thereafter potentially cancer would be extremely rare and therefore not justifying adding a progestogen routinely nor regular endometrial scanning either.

Sorry, 'not cost-effective due to the extremely low risk of harms, due to the very low dose' is for short term use and it can't be extrapolated for long term use. Besides, many users are not following the dosage indicated in the leaflet and tweaking doses at their own risk in order to relieve symptoms.

The effect of systemic oestrogen on the uterus has been much studied and the dose dependent nature quantified.

Systemic and topical are quite different routes of administration and the levels of absorption are not comparable.

... these have been extensively examined by the medical researchers and professionals to come to their informed conclusion that endometrial hyperplasia and thereafter potentially cancer would be extremely rare and therefore not justifying adding a progestogen routinely nor regular endometrial scanning either.

Again, this 'informed conclusion' is based on observational data, there are no studies to corroborate this for long term use, only for short term use (12 months)

Susysunday,

As I have already said before, my questions are not intended to scare anyone, their sole purpose is to clarify what's in stake here, risk/benefit ratio. That said, I think it is very wise to follow the manufacturer instructions regarding dosage, just to be on the safe side.

Wishing you well.

Conolly X

[Otter15]

I'm now living in Spain where I saw a gynaecologist as my atrophy was really bad again after switching back to Vagifem from ovestin. I told her what I'd been told at home about only using for three months etc. She said in Spain it's for life and 2/3 times a week (but no more) so who knows??

I think for some people it might be worth finding out where your atrophy actually is. Apparently mine is mainly outside and just inside so using Vagifem - which I struggled with for a year and ended up with atrophic vaginitis even using it daily - even half way was no use to me. She advised me to use my finger rather than the applicator when applying it and it is, so far, working. At the start I needed yes on the day I didn't apply the ovestin but now I don't. I'm using it three times a week at the moment but will try to get to two once it's fully settled.

Just to let you know too, OTC ovestin costs 13 euros.

Hope this is helpful to some. It's a horrible thing to have!

[CLKD]

It is horrid, for me it was like razor blades up there  : dryness, vagina sticking together ....... so Ovestin has really eased symptoms.

How much is 13 Euros in old money