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[Hurdity]

I was googling around yesterday as you do ? and landed on one of the Wiki sites which was quite illuminating about the different types of progesterone available ? although I don't know how up to date it is.

Amongst what appeared to be some proprietary buccal and sub-lingual formulations of progesterone in some far off countries with languages I can't read (Russian, Polish) etc I came across reference to a product called Luteina and on further investigation, found a paper looking at this product ? see link and abstract:

https://www.termedia.pl/Hormonal-replacement-therapy-based-on-the-transdermal-estradiol-and-intravaginal-progesterone-8211-evaluation-of-efficacy-and-tolerability,4,526,0,1.html

Paszkowski T. Hormonal replacement therapy based on the transdermal estradiol and intravaginal progesterone ? evaluation of efficacy and tolerability. Menopause Review/Przegląd Menopauzalny. 2003;2(3):61-66.

Hormonal replacement therapy based on the transdermal estradiol and intravaginal progesterone ? evaluation of efficacy and tolerability

The aim of the present study was to assess the efficacy and tolerability during HRT with the use of transdermal estradiol and progesterone in vaginal tablets.

Fourty one women aged 44?59 were recruited for HRT including transdermal estradiol (40 mcg/24 h; Estroplast, Adamed) and vaginal micronized progesterone tablets (50 mg bd; Luteina, Adamed) in either sequential (25 women) or continuous regimen (17 patients). The patients were followed-up for 3 months for the quality of life improvement (Greene Climacteric Scale and SSA-P questionnaire were used), blood lipids, bleeding pattern and ultrasonographic appearance of endometrium.

The quality of life significantly improved after 4 weeks of therapy with further improvement observed in the following 2 months of HRT. After 3 months of therapy, a significant decline in total cholesterol and LDL levels was observed with unchanged HDL level. After 3 months of treatment the median endometrial thickness was 4.3 mm (range 2.0?7.6 mm) and did not differ significantly from the baseline value. In none of the patients sonographic abnormalities were found in endometrium after 3 months of treatment. 5 out of 17 patients receiving combined continuous therapy (29.4%) reported spotting episodes during the first month of therapy. Two of those patients stopped HRT due to the intolerance of spotting/bleeding. In the remaining 3 patients bleeding episodes had a tendency to shorten or disappear in the 2nd and 3rd treatment cycle and they formed no reason for HRT discontinuation. Of the 25 patients who received sequential HRT, none reported abnormal bleeding during the observation period (the average duration of withdrawal bleeding was 4.0 days).

Conclusions: HRT based on transdermal E2 and vaginal P results in the significant improvement of the quality of life and favorable changes of the blood lipids profile. Progesterone containing vaginal tablets (50 mg bd) provides an effective endometrial protection during estrogen replacement therapy.
   
Unfortunately the full text pdf is in Polish or Russian so no point in downloading it but the results summary are very clear ? there is an existing 50 mg micronized progesterone product called Luteina which has actually been studied in the context of HRT and endometrial protection rather than fertility. I can't really find out much about it although I found a site in the Ukraine that sells it ? but posting this would be a commercial link. Because it is very foreign I can't even find the manufacturer. This name is also used for some sort of food supplement in UK as well as maybe formerly a proprietary sub-lingual or buccal formulation, so all quite intriguing.

Well here is one site (maybe Czech Republic?)  ? don't think this is a commercial link because I can't read it and only multi-lingual English speakers will be able to!

https://www.doz.pl/leki/p58-Luteina

Would love to know the manufacturer, whether it is still available, and whether any menopause specialists would be able to get hold of it to prescribe off-licence - because it looks like it has been studied ? though not sure what the regulations are in these countries? However if Czech Republic or Poland prescribe this then surely it is EU regulated? If Ukraine/Russia then presumably not.

I know it can be really annoying if members to post about stuff that is irrelevant and not available in UK so of limited applicability but this is the first time I have come across such a product being prescribed and tested for HRT and studied re endometrial protection so I thought it was interesting - but probably less so if the web info on it is out of date and it is not produced any more...

Hurdity x

[bear]

Hi girls,

Patient Information Leaflet of Luteina 50, 50 mg, tabletki podjęzykowe (sublingual tablets) (Adamed) in Polish and the dose/dosage for HRT (translated):

http://leki.urpl.gov.pl/files/25_Luteina50_tabl_podjezyk.pdf

"To prevent endometrial hyperplasia (in hormone replacement therapy) in combination with oestrogens, 50mg sublingual progesterone is most commonly used 3-4 times a day. In a continuous sequential regimen, the medicinal product is used sublingually for the last 12-14 days of the 28-day cycle. In a continuous combined regimen, progesterone is administered 1 daily uninterrupted. The dose of progesterone should be dependent on the oestrogen dose, to protect the endometrium from the proliferative effects of oestrogens."

PIL for Luteina 50mg tabletki dopochwowe (vaginal tablets) (Adamed) and dose/dosage (translated):

http://leki.urpl.gov.pl/files/25_Luteina_tabl_dopochw_50.pdf

"In combined hormone replacement therapy with oestrogens use 25 to 50 mg of vaginal progesterone twice daily in sequential therapy from day 15 to cycle 25 or in continuous daily therapy."

BeaR.

[Tc]

Thank you hurdity and beaR. X

[Hurdity]

Hi again - thanks bear - it's a bit more complicated than that. I've also discovered I can read some of the polish on my phone but can't reproduce it on here as I'm not logged in and also copying and pasting on phone is tricky  .Also it doesn't translate pdfs only web pages. Some of the sties are in Russian.

The main thing is I found the first sub-lingual stuff you referred to bear on wikipedia as I mentioned below but on googling found the research into the vaginal tablet - that was the bit that interested me as I think vag prog is the way to go although it was interesting also to discover the sub-lingual formulation. However the point about the latter is the daily dose is high so not much advantage really as it absorbed systemically before reaching the uterus so I would say inferior to vaginal delivery.

However if women were desparate to use sub-lingual preparations - at least this is a standard proprietary one not compounded!

Anyway I managed to google the Luteina prog capsules and there is an spc  for it ( in polish as pdf). I'm not sure if it's micronised and I'm too tired to look now. However the product info talks about 50, 100 and 200mg doses - wo whether these are different strengths in different packets - not sure. The research I posted is quite old ie 2003 but nevertheless if still available, it is a low dose prog used with low/medium estradiol patch so potentially very useful.

The company that makes them is Adamed. I wonder why this hasn't been explored by Pharma or investigated by EU  probably monopolies by the big guns I expect.

How to find out more and whether UK docs can legitimately get hold of them seeing as we are still in the EU ( sadly only just....). Any Polish speaking members still here (there was a lovely member a while back but she left ) ??

haha stellajane - yes that happened to me too! Also the generic names of the different progesterones - that's how the prometrium confusion came up too....

Anyway probably only a tantalising glimpse of what's out there.....

Hurdity x

[Mogster71]

Oh goodness, this would be amazing if we could get hold of it...how many women give up on HRT because of the dreaded progesterone. Thanks for sharing, even if it's not possible to get (yet...?)