This is great news pepperminty - thanks for posting and all the links. Now I recall in the distant past there was some talk about such a product being developed. Personally I think it is a great alternative for women who just want to take one pill but still take bio-identical hormones.
Re the food issue - its not a question that you can or can't. It's a question of differential absorption under fasting or fed states. Previous studies have shown that the bioavailability of progesterone is increased with food and the instruction is to take without food. Whatever is done (with or without food) needs to be consistent to ensure greater consistency in systemic levels.
If you look at the links pepperminty gave the SPC for Bijuve says this:
Food Effect
"Concomitant food ingestion increased the extent of absorption (AUC) and peak plasma concentration (Cmax) of the progesterone component of Bijuve relative to a fasting state when administered at a dose of 100 mg. Concomitant food ingestion had no effect on the AUC of the estradiol component of Bijuve, but the rate of estradiol absorption was faster under fasting conditions compared to the fed state. Food increased the Cmax and AUC of the progesterone by 82% and 2.7-fold, respectively, relative to the fasting state.
After multiple doses of Bijuve (estradiol and progesterone) capsules, 1 mg/100 mg taken under fed conditions, the tmax (the time at which the maximum concentration is attained) for estradiol is approximately 5 hours and approximately 3 hours for progesterone (See Table 2, below). Steady state for both estradiol and progesterone components of Bijuve, as well as estradiol's main metabolite, estrone, is achieved within seven days. "So it looks like the idea of taking it with food is to slow down the
rate of absorption of estradiol compared with fasting state - so you don't get sudden peaks (and troughs), and also this (taking with food) has the effect of increasing the bio-availability of progesterone - which is good in terms of endometrial protection.
If one needed more oestrogen ie topping up with gel then really there would be no point in having the combined pill as one might as well stay with gel for the oestrogen component I would say?
Hi Perinowpost,
I was under the impression that it is utro as it says body identical . Hopefully the other very well informed and supportive members can help shed some more light. I wonder what the consensus is -where it has been in use abroad - i am assuming it has in Europe maybe ? Getting NICE to approve anything for women and menopause here is not an easy task .
PMxx
Just to clarify - Utrogestan is the brand name for the commercial progesterone preparation manufactured by Besins. It is not a type of progesterone. Progesterone = progesterone. Biologically and medically there is only one type. So when the product says it contains progesterone, that is what it contains - the one and only bio-identcial progesterone structurally identical to our own.
In non-medical "lay" conversations we always refer to progesterone when in fact we mean "progestogen" ie the progesterone like compound used to protect the endometrium. Progesterone is a progestogen....If the term progesterone is used in a medical product then it means progesterone...
So you can take Bijuve or Utrogestan with or without food but it will have a different metabolic time course in the body (known as pharmacokinetic properties - as written in the SPC info!).
I also agree with sheila99 - as has been said many time over the past 10 years on this forum - that we also need more licesned options for progesterone only! This might mean using exsiting products but varying dosages eg licensed alternate day vaginal progesterone and the oestrogen doses that this can work for - to eliminate all the trial and error going on...or longer cycles for post-menopausal women etc How many times do we have to shout about this and when will they listen?!!!
Hurdity x