I have removed my comments so as not to cause 😳 I must have been thinking of another new product out there as there is definitely a new product that says can cause irritation after a while.
But as you say not this one that I can see, it's only got 2 lots of 12 weeks trials however which is rather low IMO so hope it helps. 😊
No probs Maryjane!! Easily done - with so much going on!
I have found a very detailed product monograph on this you might be interested in although it is so long you might glaze over after a while - I certainly did so just had a quick skim of parts of it!!
Several things stood out:
There were 6 trials investigating it. One of these was in fact a 52 week study.
Second thing and pretty important I would say - is that only DAILY USE provides a comparable efficacy with current products - Vagifem and the estriol creams. The studies (ie Intrarosa) did not in fact compare these directly from what I gather but comparisons were made with the other products (ie Vagifem etc) from the studies into them (ie Vagifem etc). Daily use may prove a no-no for some. The study which looked at daily for a fortnight followed by twice weekly maintenance dose showed no significant difference from placebo after 12 weeks.
However as with the other two new products (Blissel and Imvaggis if I've got the names right!) because its efficacy and safety did not include women on systemic HRT then the info states it should not be used in women on concurrent HRT. This looks like it is precautionary.
Other info I gleaned somewhere in the tome - systemic levels of androgens and estrone after treatment ( 12 weeks I think) were significantly different from placebo but within post-menopausal range.
Increase in systemic levels of estradiol and estrone were comparable with 10 mcg Vagifem ( not compared directly in the Intrarosa study).
There was a strong placebo effect with regard to painful intercourse - thought to be due to the lubricating effect of the fillers (the coconut oil derived product) ie placebo capsules were somewhat effective just in this measure of efficacy (I didn't note the stats!).
There were questions marks over the effect on the breast especially but this as always is complex re oestrogen receptive cancers and systemic exposure sometimes to even low dose of estradiol?
https://www.ema.europa.eu/en/documents/assessment-report/intrarosa-epar-public-assessment-report_en.pdfThose are just random points I picked out as of interest so hope this is helpful
Hurdity x