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[Hurdity]

Although I don't use estradiol gel myself (I tried Sandrena for a short while) I have been puzzled and intrigued by this ongoing discussion about Oestrogel vs Oestrodose and the alleged differences so I decided to write to the manufacturers about it.

Therefore I wrote to Besins asking very specific questions and have had several e-mails in reply.

The upshot is – THEY ARE EXACTLY THE SAME PRODUCT!

There have been posts on this forum talking about different carrier ingredients in the two products and inferior manufacture (of Oestrodose) in Asia, a cheaper product etc – but none of this is true. It is all manufactured by Besins in France.

Here is the explanation (I am quoting from their various e-mails):

“Oestrodose is the same as Oestrogel. In the UK the product is branded Oestrogel, some other countries such as France call the product Oestrodose. In the UK the parallel imports of Oestrogel are all sourced from France and are labelled Oestrodose.

All of the Besins Oestrogen Gels have exactly the same qualititative and quantitative compositions and are all manufactured at Besins Healthcare, Belgium.
... all of the products are identical in terms of the composition, packaging supplied and manufacturer and so there is no difference in hot/cold countries.”

“ Canisters for Oestrodose and Oestrogel are different shapes but the products (UK and French, as well as all Besins Oestrogel products) are tested to the same finished product specification and are considered identical.

The bottles/canisters of Oestrogel and Oestrodose are both made from polypropylene. The gel is held within a pouch inside the canister and both Oestrodose and Oestrogel use a low-density polyethylene (LDPE) pouch.

The pump mechanism of both products dispense the same amount per individual pump. I can confirm that both pump mechanisms dispense 1.25mg of gel per depression and provide 64 doses per bottle.”

There is only one formulation for manufacturing this product and the stabilities on the product, whether Oestrodose or Oestrogel, are all compliant. There was no significant difference in the past 20 years in stability studies for this product. However, the stability studies are made on products not leaving the factory and stored in the optimum conditions for the complete shelf-life period, although we have stability studies for the following conditions: 25℃ & 30℃ for 36 months and 40℃ for 6 months.


The product Oestrogel distributed in the UK is managed by Besins Healthcare from the manufacturing facility to your distributor in the UK.


“Both products are manufactured and filled/packaged by Besins before arriving in the UK.

The importer (a parallel import company) will receive the French Oestrodose product. They remove the Besins carton and leaflet, add their own label to the bottle and re-pack the bottle into their own carton with their own leaflet. When Oestrogel is received in the UK, no changes are made to the packaging or leaflets.


This also accounts for the relabelling some women have noticed ie there are 3 different containers for the estradiol gel all manufactured by Besins in France: the one labelled Oestrogel packaged by Besins for UK; the one labelled Oestrodose packaged by Besins for France, and the one labelled Oestrodose by the parallel import company which repackages the France Oestrodose. Only the outer packaging (the bottle you see) and the information leaflet changes – the inner pouch containing the gel is not touched.

I would suggest that differences in ambient temperature may cause a difference in consistency in the same product – I have noticed this myself with testosterone gel – sometimes it seems runny and sometimes not and I think this is due to room temperature.

This doesn't explain the perceived difference between the two (Oestrogel and Oestrodose) by some women and unless the parallel importer stores the product at higher temperatures than the stability studies (ie more than 40 deg for 6 months) this is unlikely to account for any differences.  I have written to the parallel importer as well to ask about this but have yet to receive a reply....Stellajane wrote to them last year about the packaging issue where Chemilines gave a brief explanation – which she posted but still the myth about differences continue. I'll update all the threads where I can find this discussed just to reassure women!

I do hope this reassures many of you who have been worried about this and concerned to get the “superior” Oestrogel – this is a myth and you can apply your oestrogen gel  - whether it be labelled as Oestrodose or Oestrogel with confidence that it will work (or not) for you – and if not, it has nothing to do with the name on the label!

Hope this is helpful

Hurdity x

[SueLW]

This is so much more than helpful Hurdity!  This is brilliant.  I have been worrying, as a new Oestrogel user, that when I have to open my new bottle of Oestrodose, it won't work the same.  And as I have so many hormonal imbalances going on at once, it's critical that loose spanners are not thrown into the mix if possible.

You have really set my mind at rest.  I am printing this out for the future.

[Taz2]

Thanks for taking the time to research this Hurdity. It will be really helpful for women who may believe that the two products are different.

Taz x 

 

[MIS71MUM]

Hi Hurdity

Thanks for your detailed information on the 2 gels.

I too, have an Oestradose in my cupboard which I have put off using in case it was sub-standard!

[donnacrichton]

Thank you so much for this clarification. I have recently started this again and my pharmacist has had trouble getting estrogel. The fear I had was irrational. This makes me feel so much better. 

[Joaniepat]

I wonder why Besins didn't have the common sense to give the product just one name, then none of this would have been necessary 
JP x

[dangermouse]

I remember checking the full ingredients a year or so ago on the the Besins website when someone was asking about it and they were different. It may have simply been something to do with the packaging as some require more preservatives than others. Maybe they started off slightly different products but legally had to make them the same if they are now showing the same ingredients.

This may explain why some found the product to be more runny.

[Tempest]

They were different when I checked too, Dangermouse. I was also informed that the Oestrodose was a bulk repackaged product - shipped in bulk from the manufacturer and repackaged by various distributors in the UK. At the time, the original Estrogel was packaged at manufacturing source. I believe certainly at that time, it was affecting the consistency of the product.

Things may well have changed since. xxxx

[Hurdity]

As per my post - the product is not repackaged from the raw material - so the information can't have come from Besins otherwise they would have said in their correspondence, surely? I have never read anything (including a year or more ago) which suggests that the constituents are or were different in Oestrodose and Oestrogel and members on here have had both patient information leaflets which have shown exactly the same ingredients! Besins do not list the ingredients on their website (that I can find anyway) and the agency which lists all the product information leaflets and SPC details  (eMC) has never listed Oestrodose to my knowledge - because what we get is the same product - Oestrogel in UK - whatever the label says! I have written to them again just to clarify finally - although my questions were very specific and they would surely have said if formulations have changed in the past year?

I wonder why Besins didn't have the common sense to give the product just one name, then none of this would have been necessary 
JP x

I imagine it would be the recipient/importing country that specifies the name - if you look at Besins website the same thing happens with utrogestan - called Prometrium in some countries and there is also another name for oestrogel too - which I have never heard of! Oestrodose was the original name it seems - as this is what it's called in France - unless we have just retained the original name and they decided to change it in France - who knows?

Anyway the important thing is a mystery has been cleared up hopefully!!! I do like to get to the bottom of things

Hurdity x

[Joaniepat]

Thanks Hurdity, well done! 
JP x

[dangermouse]

I did a search for when discussed before and it was the excipients that differed (the Carbomer one) which they don't have to list in the ingredients. The link no longer exists on their website. It may have been why some found it more watery at that time and I remember they stated that one of them was manufactured in Asia.

It may just have been like Cadbury's where they add the non-melting chemicals in the hot countries!

“Besins list them separately here http://www.besins-healthcare.com/index.php?mode=product&submode=2&group=2
and the only detailed ingredients I could find for both are:

Oestrodose:
The drug brand named Oestrodose contains generic salt-Estradiol Hemihydrate and is manufactured by Besins.

Generic Salts
Estradiol Hemihydrate

Available types of drugs
Gel; Topical; Estradiol Hemihydrate 0.06%

Oestrogel:
of gel contains 0.6 mg of estradiol (as estradiol hemihydrate); excipients: carbomer 980, triethanolamine, 96% ethanol, purified water”

[Hurdity]

When I did the post about these products I posted extracts from my correspondence with Besins rather than produce the letters in full so here is the bit about Asia and manufacture elsewhere – which actually is covered in their statement I did post ie “All of the Besins Oestrogen Gels have exactly the same qualititative and quantitative compositions and are all manufactured at Besins Healthcare, Belgium”.

This is the other bit from one of their letters  “We do not manufacture any products in the Phillipines and all of the products are identical in terms of the composition, packaging supplied and manufacturer and so there is no difference in hot/cold countries.”

Rest assured dangermouse I asked several very specific questions including the bit about hot countries as this was the only reason I could think of that there could be different ingredients.

The post you quote from maybe a year ago I also read at the time.

Here is the up-to-date link to Besins products with all the alternative names for their identical products – the ingredients were not listed on there at the time of that post: https://www.besins-healthcare.com/products/#womens

The first bit of that list which you have requoted is not a list of ingredients – it is a description of what Oestrodose is ie topical gel whose active ingredient is estradiol hemihydrate. The second is the list of ingredients of all their estradiol gel including Oestrodose. As far as I know they have to list all of the ingredients because of possible allergies.

I also remember that post and did my own research at the time and there was no list of ingredients for Oestrodose separately. It was all rumour and supposition and inference as far as I can make out.

Because the subject has been raised yet again – this is when I decided to contact the manufacturers.

The parallel importers Chemilines was founded by two Asian brothers and have offices globally including Asia – this is presumably the origin of the rumours that Oestrodose is manufactured in Asia. As I said I have written to them just to find out what happens to the Oestrodose destined to be repackaged as Oestrogel – but I doubt it is transported to Asia and in any case as I quoted there have been stability studies carried out on the product to 40 deg for 6 months. http://www.chemilines.com/about-2/

Since the product has a three year date on it (I think) – some of the current preparations will have been manufactured a while ago and if the products used to be different (and may still be in use) then Besins would clearly have said so.

I did this investigation because the subject continues to be raised and as I said in my first post – because I was puzzled at the whole idea of two different products being sold as the same if they weren't – as Stellajane pointed out. I have also written to Besins again as I said in my previous post.

The idea was to reassure women who have used or continue to use these two products, not to continue the controversy and leave questions as to any differences. If there is anything different in responses from the companies that suggests there has been a difference - I will post them!

Hurdity x

[CarryWarry]

Thanks for this invaluable info!  Love this site. x

[Optimist]

I stopped using oestrogel because when they'd run out I was given oestrodose. Within 3 days off using it I suffered with chronic headaches of which I've never had before this lasted 5 days and I went to the gp who told me to stop all oestrogen for 3 days. Within 2 days the headaches had stopped and I felt well again. I was then given oestrogel again and all was well. I however decided to go back into patches of which suit me so much better. I could not take the risk of being given oestrodose again. So I would absolutely dispute that they are the same alongside many others that have had bad side effects from using the oestrodose. The oestrodose was thinner and smelt strongly of alcohol and took longer to dry. Whether a carrier agent would cause this I don't know. I'm afraid unless you've tried it and felt the difference you could believe they are the same by the info they're giving however there have been too many reports from too many women, of side effects to swallow this information and I've lived and breathed it. Very unpleasant experience I wouldn't wish on anyone 👎🏼

[Hurdity]

I can't explain why you experienced this Optimist - but it is clear from the information given by Besins that they are not and cannot be different products - as the gel is put into the inner pouches only at Besins in France (according to their info) - and only the outer packaging changes. Besins only make one such product so the carrier agents in both are identical.   The only possibility is the way the product has been stored and whether the parellel importer shunts the different boxes of the stuff around the world and stores it in unfavourable conditions eg if occasionally if there is a shortage of the French Oestrodose for the UK market - maybe some is brought from elsewhere and repackaged again. I can't imagine this would happen often if at all (but maybe?) and it wouldn't alter the actual contents though - unless it was "fake" oestrodose?!!!  As I said I contacted Chemilines to ask about it but haven't had a reply!

Are you saying you think Besins are not providing the correct information? This would be quite serious if so, for medical reasons. They do say that they have no control over the product once it leaves their premises - Oestrogel and Oestrodose.

I'm sorry to hear about your reaction and headaches but the cause seems to be a mystery for the time being! Even though I don't use it myself I was intrigued as to what, if any, difference there could be!

Hurdity x