Menopause Matters Forum

Menopause Discussion => All things menopause => Topic started by: Hurdity on May 08, 2019, 07:38:47 AM

Title: Vaginal progesterone inc Utrogestan, and endometrial protection: some studies
Post by: Hurdity on May 08, 2019, 07:38:47 AM
Hi there - this subject keeps coming up and newer members won't have seen all the threads where these studies have been quoted so I'm doing a separate post as I can't always find the old threads!

Vaginal progesterone in menopause: Crinone® 4% in cyclical and constant combined regimens  2000

D.de Ziegler124, R.Ferriani3 , L.A.M.Moraes3 , and C.Bulletti4

Human Reproduction, Vol. 15, (Suppl. 1), pp. 149-158, 2000

https://humrep.oxfordjournals.org/content/15/suppl_1/149.full.pdf

Compliance with hormone replacement therapy (HRT) is notoriously low despite ample documentation of clinical efficacy. The two major reasons given by women who discontinue HRT are uterine bleeding and side-effects. The recent development of a controlled and sustained vaginal progesterone gel allowed single daily application and made prolonged use such as for menopause possible. Here we report our clinical experience with two therapeutic options for HRT using natural progesterone administered vaginally. A first group of 69 menopausal women received the sustained release vaginal progesterone gel, Crinone® 4% (45 mg daily) from days 1-10 of each calendar month with oestrogens taken continuously. A second group of 67 women received Crinone 4% twice weekly in conjunction with continuous oestrogen therapy. Endometrial thickness was evaluated before and after 6 months of treatment. Histological verification was obtained in all cases of abnormal bleeding. At 6 months, 63 out of 69 (91.9%) women receiving progesterone cyclically experienced predictable withdrawal bleeding. The vast majority, 54 (80.6%) of 67 women receiving Crinone in constant combined association with oestrogen therapy, remained amenorrhoeic throughout 6 months of therapy. AH cases of abnormal bleeding were biopsied and no hyperplasia was seen. Our results indicate that both regimens using the sustained release vaginal progesterone gel controlled bleeding in HRT. Combined with the lower incidence of side-effects characteristic of vaginal progesterone, both vaginal progesterone regimens have the potential of improving HRT compliance.

Efficacy of oral micronized progesterone when applied via vaginal route.2004

Choavaratana R1, Manoch D.
http://www.ncbi.nlm.nih.gov/pubmed/15222511

Abstract
The aim of the study was to compare the efficacy of oral micronized progesterone when applied by the vaginal route. The comparative study of serum progesterone levels between oral and vaginal micronized progesterone administration was conducted in sixty female volunteers. The subjects were equally divided into two groups to receive the drug either via the oral or vaginal route. The subjects' profiles showed that there was no significant difference in general characteristics between these two groups. The blood tests for estrogen and progesterone levels were performed on all volunteers before and after the drug administration. The data collected from the experiment revealed that the serum progesterone levels achieved by oral administration (5.06 +/- 2.95 ng/ml) differed significantly (p < 0.001) from those achieved by vaginal administration (8.26 +/- 4.09 ng/ml). The data also revealed that the serum progesterone levels of the oral administration group (4.23 +/- 2.68 ng/ml) did not differ significantly (p = 0.925) from the other group (4.15 +/- 3.40 ng/ml) when the serum estrogen level was less than 30 pg/ml. On the contrary, when the serum estrogen level was at least 30 pg/ml, there was a significant (p < 0.005) difference in the serum progesterone levels between these two groups (6.32 +/- 2.99 ng/ml for the oral route and 9.76 +/- 3.23 ng/ml for the vaginal route).

Endometrial effects, bleeding control, and compliance with a new postmenopausal hormone therapy regimen based on transdermal estradiol gel and every-other-day vaginal progesterone in capsules: a 3-year pilot study
Cicinelli et al 2005

http://apps.elsevier.es/watermark/ctl_servlet?_f=10&pident_articulo=90010354&pident_usuario=0&pcontactid=&pident_revista=605&ty=58&accion=L&origen=zonadelectura&web=www.elsevier.es&lan=en&fichero=605v83n06a90010354pdf001.pdf

(The above link doesn't seem to work any more...so try this one below)

https://www.fertstert.org/article/S0015-0282(05)00403-6/fulltext

In a 3-year prospective study, 30 postmenopausal women received transdermal E2gel and every-other-day vaginal P in capsules. At study completion, endometrial thickness was significantly reduced as compared with baseline (2.7 0.5 vs. 3.4 0.9 mm), endometrial biopsy showed endometrial atrophy in all cases, and amenorrhea was achieved in 92.6% of cycles, while excellent patient satisfaction was achieved. (Fertil Steril 2005;83:1859–63. ©2005 by American Society for Reproductive Medicine.)

Transdermal estradiol and oral or vaginal natural progesterone: bleeding patterns.2010
Di Carlo C1, Tommaselli GA, Gargano V, Savoia F, Bifulco G, Nappi C.
http://www.ncbi.nlm.nih.gov/pubmed/20575654

Abstract
OBJECTIVE:
To evaluate the effects on bleeding pattern of two different doses of natural progesterone (NP) administered per os or per vagina in association with transdermal estradiol in a continuous, sequential estrogen-progestin therapy.
METHODS:
A prospective, randomized trial was conducted on 100 patients randomized into four groups. Each group received transdermal 17beta-estradiol treatment at the dose of 50 microg/day. Groups A and B received NP per os at the dose of 100 mg/day and 200 mg/day, respectively. Groups C and D received NP per vagina at the dose of 100 mg/day and 200 mg/day, respectively.

RESULTS:
After 12 cycles of treatment, no significant differences were observed in endometrial thickness between groups, suggesting that all treatments are effective in balancing the effects of estradiol on endometrium. Regarding bleeding control, patients in Groups C and D showed a higher number of episodes of regular bleeding than patients in Groups A and B and fewer episodes of spotting. The better control of bleeding was associated with a higher treatment compliance in patients who received vaginal NP, with a larger percentage of women completing the study.

CONCLUSION:
Transdermal estrogen replacement therapy combined with 100 mg of micronized NP administered per vagina from the 14th day to the 25th day of each 28-day cycle leads to good cycle control and provides excellent patient satisfaction without serious side-effects. This therapy could be a treatment of first choice in early postmenopausal patients.


Endometrial response to concurrent treatment with vaginal progesterone and transdermal estradiol. 2012
Fernández-Murga L1, Hermenegildo C, Tarín JJ, García-Pérez MÁ, Cano A.

http://www.ncbi.nlm.nih.gov/pubmed/22321028'


ABSTRACT Objective To describe the effect of the intermittent administration of vaginal progesterone and a low-dose estradiol patch on endometrial stability, as assessed by the rate of amenorrhea and endometrial stimulation. Methods This was an open study in which 64 moderately symptomatic, postmenopausal women were treated in the outpatient clinic of our University Hospital for different intervals up to 1 year. The treatment consisted of a combination of patches delivering 25 µg/day estradiol and intravaginal pills containing 100 mg of micronized progesterone. Patches and pills were administered concomitantly in a twice-a-week protocol. The endometrial response was assessed by endovaginal ultrasound completed with suction biopsy when required. Results Both cumulative amenorrhea and no-bleeding rates increased progressively and reached 88.9% and 100.0%, respectively, by the 12th month. Isolated or repetitive episodes of bleeding, bleeding and spotting, or only spotting were reported by three, four, and 12 women, respectively. Endometrial thickness remained unaltered. Endometrium was atrophic in the seven women in whom a biopsy was performed. Conclusion The substantially reduced progestogen load determined by this combination achieved an acceptable incidence of spotting or bleeding when associated with a low estrogenic dose. There was no apparent endometrial stimulation. Additional studies are required to confirm this observation.


E-mail from information manager at Ferring ( previous manufacturer of Utrogestan) 2011

"The product monograph talks of two trials of vaginal use as part of HRT – they're small patient populations – 20 and 30 patients in each.

One study used 100mg once daily vaginally for 21 days of 28 day cycle – the study lasted a year and was undertaken in 20 patients. Symptoms were significantly reduced, bone density remained and no adverse effects were seen. The endometrium was safely protected from the estrogenic effect of 1.5mg transdermal Oestrogel.


Another of 30 patients over 36 months studied the use of 100mg vaginal Utrogestan every other day. For most patients there was absence of bleeding and good patient satisfaction. There was a reduction in mean endometrial thickness and at the end of the study endometrial atrophy was seen in all cases. Five of the 30 women dropped out due to vaginal bleeding. (1.5 mg per day Sandrena gel)"  Cicinelli et al 2005

The references are:

Spritzer et al Exp Clin Endocrinol Diabetes 2003; 111 (5) 267-273

Vilodre et al Gynecol Endocrinol 2003; 17 (4) 323-328.

Endometrial Protection: Which Progestogen Is Best? 2015
By Jeffrey T. Jensen, MD, MPH Leon Speroff Professor and Vice Chair for Research, Department of Obstetrics and Gynecology, Oregon Health & Science University, Portland
March 1, 2015

https://www.ahcmedia.com/articles/134766-endometrial-protection-which-progestogen-is-best

Extract
“The commercially available 4% vaginal progesterone gel (Crinone®) has been evaluated for endometrial protection in combination with transdermal estradiol. This product delivers 45 mg/day, and no cases of endometrial proliferation were observed in a small study involving 35 subjects. However, this is not approved for HRT and is quite expensive.”
The impact of micronized progesterone on the endometrium: a systematic review.2018

P. Stute, L. Wildt & J. Neulen (2018)

Climacteric, 21:2, 111-122,
https://www.tandfonline.com/doi/full/10.1080/13697137.2017.1421925

Abstract
Postmenopausal women with an intact uterus using estrogen therapy should receive a progestogen for endometrial protection. International guidelines on menopausal hormone therapy (MHT) do not specify on progestogen type, dosage, route of application and duration of safe use. At the same time, the debate on bioidentical hormones including micronized progesterone increases. Based on a systematic literature review on micronized progesterone for endometrial protection, an international expert panel's recommendations on MHT containing micronized progesterone are as follows: (1) oral micronized progesterone provides endometrial protection if applied sequentially for 12-14 days/month at 200 mg/day for up to 5 years; (2) vaginal micronized progesterone may provide endometrial protection if applied sequentially for at least 10 days/month at 4% (45 mg/day) or every other day at 100 mg/day for up to 3-5 years (off-label use); (3) transdermal micronized progesterone does not provide endometrial protection.



That's it for now! I'm sure there are more recent ones too. Please post any later studies if you find them...

Also a reminder that Utrogestan is manufactured to be used vaginally or orally - here is the information I also posted recently on another thread:

"Utrogestan is manufactured to be taken orally or vaginally - it is only in the UK that it is only licensed for oral use as part of HRT (but the 200 mg capsules is now only licensed or rather marketed, for vaginal use for infertility).  You will see the database of medicines (the "base de donnees publique des medicaments") it is listed as: "UTROGESTAN 100 mg, capsule molle orale ou vaginale " - similarly for 200 mg. In the info it gives the indication for vaginal route, amongst other uses, if side effects are experienced with oral use:

"Dans toutes les autres indications de la progestérone, la voie vaginale représente une alternative à la voie orale en cas:

· d'effets secondaires dus à la progestérone (somnolence après absorption par voie orale)."

In all other indications of progesterone, the vaginal route respresents an alternative to the oral route in the case:
.. of  side effects due to the progesterone (sleepiness after absorption by the oral route).

http://base-donnees-publique.medicaments.gouv.fr/affichageDoc.php'specid=61673424&typedoc=R

Hope this helps :)

Hurdity x



Title: Re: Vaginal progesterone inc Utrogestan, and endometrial protection: some studies
Post by: Turkish delight on May 08, 2019, 08:11:22 AM
Cool thanks Hurdity!

Noticed this paper shows half the recommended dose of micronised progesterone vaginally compared to NICE guide of 200 mg orally.
See copy paste under here...

"CONCLUSION:
Transdermal estrogen replacement therapy combined with 100 mg of micronized NP administered per vagina from the 14th day to the 25th day of each 28-day cycle leads to good cycle control and provides excellent patient satisfaction without serious side-effects. This therapy could be a treatment of first choice in early postmenopausal patients."

Nice guidelines are for 200 mg orally and no mention of vaginally, I have that right don't I?

I feel good about this bcz I'm on 100 mg vaginally for 14 days for 1 pump Oestrogel.

Incidentally, and unconnectedly I got my repeat of Oestrogel as Oestrodose, the label had a sticky pharmacy detailed label over one side of the box with "Oestrogel" written on it and all the details for that. I used it and have noticed no difference in any way, just one day a tad more of an alcohol whiff but that wasn't any cause for concern. Thought you'd be glad to hear this after the constant debate re differences.

TD


Title: Re: Vaginal progesterone inc Utrogestan, and endometrial protection: some studies
Post by: Wrensong on May 08, 2019, 08:44:11 AM
Thanks for taking the time to post this, Hurdity.  Makes for interesting & reassuring reading & great to have it all together.  Will be helpful to many members, I'm sure.
Title: Re: Vaginal progesterone inc Utrogestan, and endometrial protection: some studies
Post by: Beaker on May 08, 2019, 12:50:39 PM
Thanks Hurdity - this answered a few questions I was about to ask  :)
Title: Re: Vaginal progesterone inc Utrogestan, and endometrial protection: some studies
Post by: Karen P on May 08, 2019, 03:45:10 PM
Thank you so much, this is really helpful info, and has put my mind to rest.

Karen x ::)
Title: Re: Vaginal progesterone inc Utrogestan, and endometrial protection: some studies
Post by: Sheanie on May 08, 2019, 04:19:56 PM
Really useful information. Thank you! I am wondering if a table of some sort with all the results in would be a good idea.... I'm also wondering how I'll find the time to make one. Essential for that presentation though. I will post it if I make it.  :)

I'm on 2 pumps of Estrogel and was taking one 100mg Utrogestan orally every day, but after 3 months, I found it made me very drowsy. I'm on one 100mg Utrogestan vaginally every other day now. Feeling a lot better now. And this research evidence makes me feel reassured I'm safe doing that.
Title: Re: Vaginal progesterone inc Utrogestan, and endometrial protection: some studies
Post by: Hurdity on May 09, 2019, 03:36:15 PM
Sheanie....however it would be better to have a scan at some point to check whether this regime is suitable for you as an individual and be vigilant about any suspicious spotting or bleeding.

Hurdity x
Title: Re: Vaginal progesterone inc Utrogestan, and endometrial protection: some studies
Post by: Hurdity on August 18, 2019, 08:02:11 AM
Bump - for members asking about the safety of vaginal utrogestan on utrogestan/estrogel support group.

Also to re-emphasise (and re-post) my last point in the main post because the question comes up regularly and it seems that some health professionals and menopause "experts" are not aware of either the studies nor that utrogestan is actually manufactured (on the continent) to be taken via both routes - oral and vaginal.

Utrogestan is manufactured for oral or vaginal use

Utrogestan is manufactured to be taken orally or vaginally. It is only in the UK that it is only licensed for oral use as part of HRT - now using only the 100 mg capsules. The 200 mg capsule is now only licensed or rather marketed, for vaginal use for infertility but was formerly licensed (or rather packaged) for HRT. In other words the same capsules can be taken either way - by mouth or by vagina.

You will see the French database of medicines (the "base de donnees publique des medicaments") it is listed as: "UTROGESTAN 100 mg, capsule molle orale ou vaginale "  (soft oral or vaginal capsule) - similarly for 200 mg. In the info it gives the indication for vaginal route, amongst other uses, if side effects are experienced with oral use:

"Dans toutes les autres indications de la progestérone, la voie vaginale représente une alternative à la voie orale en cas:

• d'effets secondaires dus à la progestérone (somnolence après absorption par voie orale)."

Translation: In all other indications of progesterone, the vaginal route respresents an alternative to the oral route in the case:
.. of  side effects due to the progesterone (sleepiness after absorption by the oral route).

http://base-donnees-publique.medicaments.gouv.fr/affichageDoc.php'specid=61673424&typedoc=R


Hurdity x
Title: Re: Vaginal progesterone inc Utrogestan, and endometrial protection: some studies
Post by: kayellvee on August 18, 2019, 08:53:09 AM
Thanks, Hurdity and for your reply to me in the other thread.  I'll switch to vaginally and hope that it helps.
Title: Re: Vaginal progesterone inc Utrogestan, and endometrial protection: some studies
Post by: Tc on August 18, 2019, 10:08:22 AM
Thanks hurdity. So glad you bumped this as I missed it first time.

I've taken utrogestan for 2 cycles orally at 200. Mg.  Bleed day 8 each time.  Headache nausea and migraine throughout use.. I've just started 3rd cycle 200mg oral dose last night and already getting the side effects. It's obviously a pattern which is going to repeat.

So i want  to switch to use vaginally tonight  From reading this info 100mg is sufficient  if used vaginally for 12 days as it's more direct route to uterus. . But the info and trials all refer to  low dose eastrogen.use.  I am on 2x100 estradot patch. .  So I'm a bit wary about only using 100mg P . There doesnt seem to be a lot of information out there on how much P is needed to protect uterus during high dose eastrogen use. My GP seems to think its unchartered territory and cant offer any advice 

I could err on side of caution and use 200 vaginally but it doesnt seem anyone else uses it this way.  I 'm not sure if using too much vaginally might imbalance me the same way too much orally did  or whether I need to worry about atrophy of the lining 

Last bloods in June were 179pmol E.  But I dont know whether to go by this or to go by the fact I'm on such high E dose.

Thank you for taking the time to post and bump this thread. I'm sure it has and will answer a lot of questions for many ladies. I guess I'm in something of a minority using such a high dose of eastrogen.and I'm still unsure what to do for the best X
Title: Re: Vaginal progesterone inc Utrogestan, and endometrial protection: some studies
Post by: Ladybt28 on August 19, 2019, 01:12:04 PM
Sorry if I haven't read this right - anyway - I use 200mg vaginally on a cycle Tc - not 100mg because I am on 4 pumps of gel which is considered on the high side although nowhere near as high as you. x
Title: Re: Vaginal progesterone inc Utrogestan, and endometrial protection: some studies
Post by: Tc on August 19, 2019, 01:22:59 PM
Thanks lady.
I didnt know of anyone else using 200 vaginally. So you've  answered my question.

Think I will use 200 to be safe side.

Xxxx
Title: Re: Vaginal progesterone inc Utrogestan, and endometrial protection: some studies
Post by: Saffy on August 19, 2019, 04:50:18 PM
Hi TC, just catching up! I use 2x100 Utro vaginally on a cycle and I'm on 2x100 Estradot twice a week but have used this dose of Utro vaginally since I started on the 25 Estradot patches  :o.
Title: Re: Vaginal progesterone inc Utrogestan, and endometrial protection: some studies
Post by: Tc on August 19, 2019, 05:00:59 PM
Hiya saffy. Aah yes. The 200 club. I'm back in after a brief foray into the 250 club. Thanks.  Do you use 7 or 12 days.    What is your bleed like Hope you don't mind me asking. But mine
is weird. Starts on day 8 of utrogestan and finishes on day 12.  So not on withdrawal as it's supposed to. 

How are you?
Title: Re: Vaginal progesterone inc Utrogestan, and endometrial protection: some studies
Post by: Saffy on August 20, 2019, 12:03:53 AM
I use 12 days (for my sins!) . My bleed is pretty textbook, starts 4 or 5 days after stopping the Utro and very light, much lighter than when I was having proper periods (and they were never particularly heavy, just horrifically painful). I only really have two days of proper bleeding and then it trails off with a bit of spotting for a couple of days (sometimes slightly longer). Slight cramping almost as soon as I stop the Utro and a bit more on the night before and first day of the bleed. The amount and pattern of bleeding hasn't changed since I was on the 25 patches, bizarrely.

I was having infrequent periods when I started the HRT, though I had just had a couple in quick succession, and I didn't bother to sync with a cycle as I just wanted to get started so I've just been lucky I guess (sound of slightly hysterical laughter...). It is strange that quite a few women seem to bleed consistently before they have completed the progesterone phase.

How am I? Who knows  ::). Libido has now fizzled out, I think my hair has started shedding again and I have a face full of spots (bleed due but I think they are worse due to the T)  >:(. Still tired, occasionally a bit 'warm', probably a bit less exhausted than I was. Muddling along with 50/50 goodish days/meh days. I keep trying to convince myself that I'm better, and I am, and I hear how others are feeling on here and I'm grateful I am not in that place but really I'm nowhere near the person I was before peri began in earnest *sigh*.

God that was cheery ;D. Oh and I am also the carrot person! xxx
Title: Re: Vaginal progesterone inc Utrogestan, and endometrial protection: some studies
Post by: Tc on August 20, 2019, 08:58:45 AM
Saffy. Thanks for sharing that.

Sorry to hear you are still having those rough days.

You saw my gravy and carrot post!! Sometimes  I wonder if I come across on here as completely loop de loop :) 

Xxx
Title: Re: Vaginal progesterone inc Utrogestan, and endometrial protection: some studies
Post by: Ladybt28 on August 20, 2019, 12:54:49 PM
Hey Tc - loop de loop  ;D absolutely but just like the rest of us!! so your in good company.
Saffy - I don't think any of us ever get back to how we were - its just if you are down at minus 10 on the scale of feeling dreadful its about how far back towards 0 (feeling OK!) you can get.  Each step down from 10 is just a bonus - how flaming sad is that!!

See the carrot and gravy post - what an absolutely ace thing to say - your niece is a wise women!
Title: Re: Vaginal progesterone inc Utrogestan, and endometrial protection: some studies
Post by: Wrensong on August 20, 2019, 07:15:14 PM
Tc - loop de loop?!  Took me a few mins to recall where I'd heard that first!  Shirley Valentine?  If so, you missed out a vital word before the 2nd loop if I remember rightly!  Won't repeat that here . . . ;D
Title: Re: Vaginal progesterone inc Utrogestan, and endometrial protection: some studies
Post by: Tracey E on August 20, 2019, 08:35:27 PM
Really useful information. Thank you! I am wondering if a table of some sort with all the results in would be a good idea.... I'm also wondering how I'll find the time to make one. Essential for that presentation though. I will post it if I make it.  :)

I'm on 2 pumps of Estrogel and was taking one 100mg Utrogestan orally every day, but after 3 months, I found it made me very drowsy. I'm on one 100mg Utrogestan vaginally every other day now. Feeling a lot better now. And this research evidence makes me feel reassured I'm safe doing that.

Hi, have you had any bleeds with taking it every other day?
Title: Re: Vaginal progesterone inc Utrogestan, and endometrial protection: some studies
Post by: Tc on August 20, 2019, 10:29:37 PM
Lady. Yep. My carrot and gravy analogy my niece has much to teach me.  And Yes wren. Shirley valentine.

 "Hiya wall, what's wrong with that? A woman 3 doors down talks to her friggin microwave".
Title: Re: Vaginal progesterone inc Utrogestan, and endometrial protection: some studies
Post by: Wrensong on August 21, 2019, 09:56:49 AM
Hahaha - yes Tc - one of my favourite films!  ;D
Title: Re: Vaginal progesterone inc Utrogestan, and endometrial protection: some studies
Post by: Hurdity on August 22, 2019, 07:54:29 AM
Bump for pricey and Wooz - asking for information about whether utrogestan was prescribed and licensed only for oral use.

Look at my last post (before the carrots and gravy  ;)!).

Hurdity x
Title: Re: Vaginal progesterone inc Utrogestan, and endometrial protection: some studies
Post by: Hurdity on September 26, 2019, 04:21:09 PM
Bump for coldlittleheart

Hurdity x
Title: Re: Vaginal progesterone inc Utrogestan, and endometrial protection: some studies
Post by: Hurdity on October 07, 2019, 04:36:04 PM
Bump for winnie1967

Hurdity x
Title: Re: Vaginal progesterone inc Utrogestan, and endometrial protection: some studies
Post by: Hurdity on November 02, 2019, 02:06:11 PM
Bumpity bump....

Hurdity x
Title: Re: Vaginal progesterone inc Utrogestan, and endometrial protection: some studies
Post by: Lolafraola on November 02, 2019, 04:04:51 PM
Tx Hurdity.
So as I understand it.
Taking Utro 100mg every other day without a break for as long as required (to counteract a low dose of estrogen) should be fine. A periodic scan should also be scheduled but there's no reason to take a break (this is what I've been told by my meno Dr).

LF x
Title: Re: Vaginal progesterone inc Utrogestan, and endometrial protection: some studies
Post by: Hurdity on November 03, 2019, 09:05:42 AM
The preliminary studies do show that this works for the number of women in the trial - and if your menopause doctor has approved it for a low dose of oestrogen aslong with regular scans then that's fab :) Good luck!

Hurdity x
Title: Re: Vaginal progesterone inc Utrogestan, and endometrial protection: some studies
Post by: Hurdity on November 12, 2019, 06:03:22 PM
Bumpity bump for AJacynM

Hurdity x
Title: Re: Vaginal progesterone inc Utrogestan, and endometrial protection: some studies
Post by: Hurdity on April 07, 2020, 10:31:34 AM
There has been regular discussion over the years about the effectiveness of taking half the dose of progesterone (Utrogestan) when used vaginally.

Some of the papers whose abstracts are quoted at the beginning of this thread, form the basis of some of the research demonstrating this, which comprise several small studies but with low to medium dose oestrogen.

In view of a recent thread citing Louise Newson's recommendation that half the licensed oral utrogestan dose can be taken if used vaginally, and also because it has been rasied before, I am updating this thread with what she actually says on her page.

Here is Dr Newson's information:

https://www.menopausedoctor.co.uk/menopause/micronised-progesterone-or-utrogestan

"How is Utrogestan taken?

Utrogestan is given as a 100 mg capsule. There are two ways of taking Utrogestan.

?   For women who have still had periods in the last 6-12 months, the usual recommended dose is two 100mg capsules, taken together each evening, for two out of four weeks, on a repeating basis.
?   For women who have not had a period for over a year, the usual recommended dose is taking one 100mg capsule every evening, without a break.

The dosage information that comes with the medication differs slightly to this, but it is far more straightforward to take it in this way and easier to remember. It is completely safe to take it in the way we have described.

Utrogestan is a natural sedative so can cause drowsiness in some women. It is therefore recommended you take it at bedtime. It is best to take Utrogestan on an empty stomach because eating food can actually increase its absorption.

Some women use the progesterone vaginally rather than taking it orally, which can be associated with less side effects. Evidence has shown that using 100mg progesterone vaginally alternate evenings as a continuous (no bleed) preparation or 100mg progesterone vaginally every evening for 12-14 days each month as a cyclical (leading to periods) preparation is safe.

Many women use the oral Utrogestan capsules vaginally or some women use Cyclogest pessaries (these contain 200mg progesterone and can be cut in half). Progesterone is not licensed to be used in this way but there is evidence to support that this is safe. Women who use it in this way should seek individualised advice from their doctor."


Hurdity x
Title: Re: Vaginal progesterone inc Utrogestan, and endometrial protection: some studies
Post by: Hurdity on July 10, 2020, 07:38:29 PM
Bumpity bump for pluto

Hurdity x
Title: Re: Vaginal progesterone inc Utrogestan, and endometrial protection: some studies
Post by: pluto on July 11, 2020, 01:27:21 PM
thank you!
Title: Re: Vaginal progesterone inc Utrogestan, and endometrial protection: some studies
Post by: Hurdity on October 11, 2020, 04:02:49 PM
Bump for babspiglet

Hurdity x
Title: Re: Vaginal progesterone inc Utrogestan, and endometrial protection: some studies
Post by: Hurdity on December 11, 2020, 09:03:26 AM
Bump for Dawn20 and anyone else who is interested and hasn't seen it.... :)

Hurdity x
Title: Re: Vaginal progesterone inc Utrogestan, and endometrial protection: some studies
Post by: lizziejt on January 05, 2021, 10:35:34 PM
This is such a useful thread, thank you @Hurdity.  I can't tolerate Utrogestan orally so I did  some research and am currently taking 100mg vaginally on alternate nights - I'm on a 75mcg Estradot patch. I did have a bleed but it's stopped now. I am wondering if this dose is enough? Any advice would be very welcome. I don't want a regular bleed as I have low ferritin. Also how often do i need to have a scan?
Title: Re: Vaginal progesterone inc Utrogestan, and endometrial protection: some studies
Post by: lizziejt on January 06, 2021, 08:44:00 AM
Hi Avalon, wow really? That makes me think I need to up my dose to nightly! Are you increasing or will you continue to monitor and how often do you have a scan? Thanks x
Title: Re: Vaginal progesterone inc Utrogestan, and endometrial protection: some studies
Post by: lizziejt on January 07, 2021, 10:11:04 PM
How annoying! I've never had a scan but will get one in a few months. Thanks for your help, good luck!
Title: Re: Vaginal progesterone inc Utrogestan, and endometrial protection: some studies
Post by: violetbat on January 10, 2021, 09:45:33 PM
I'm due to start my utro tonight. I am still peri but have been on the gel/utro combo for over a year. I have been using it viginally for most of the time . 2 tablets for 10-12 days ( depending on hoe bad the side effects are).
Since I am peri would it be ok to take just 100mg a night? I am unclear as the studies seem to suggest this regime apply to newly post menopausal women. I would love not to take as much as my body is not very progesterone tolerant( I have a bad time with my own and always know when it's increasing).
If anyone has an idea about this i would be very grateful. :-)
Title: Re: Vaginal progesterone inc Utrogestan, and endometrial protection: some studies
Post by: Kelrob12 on January 12, 2021, 10:07:34 AM
Hi,
Ive just started my next round on oral 200mg Utrogestan, and now think I do get anxious whilst on it . I had originally thought it didn't affect me but have been keeping a diary and I get more pain and anxious whilst on it. Im on 100mg patch - the meno clinic said I was ok to take vaginally 100mg for the same number of days - did anyone get anxious on Utrogestan and found it helped vaginally?
thanks Kelly
Title: Re: Vaginal progesterone inc Utrogestan, and endometrial protection: some studies
Post by: Hurdity on January 12, 2021, 10:19:02 AM
You may or may not find that 100 mg vaginally is sufficient to protect your womb with 100 mcg oestrogrn patch. Has the 200 g cyclical utro been OK so far re bleeding and womb lining?

With vaginal use the progesterone first gets to the uterus lining which is its target, whereas with oral intake it has to go through digestion and the liver first. Also orally there are a large number of metabolic breakdown products some of which are responsible for the negative side effects. However progesterone itself is sedating and can cause fatigue, headaches and lethargy in some women who are susceptible or at high doses.

If the meno clinic have advised it then why not give it a try especially as it is a lower dose?

Do let us know how you get on (maybe start another thread just for you as this one is mainly about the studies so your posts might get missed?).

Hurdity x
Title: Re: Vaginal progesterone inc Utrogestan, and endometrial protection: some studies
Post by: Anne G on May 27, 2021, 08:35:27 PM
This info is really helpful - thank you.  I'm in the menopause - last period Sept '19 - and about to start HRT as have severe anxiety and low mood issues.  Wish I'd realised years ago my "depression" was probably due to peri-m!! I've been concerned about taking Utrogestan orally so really helpful to understand I can take it vaginally and how to adjust the dose. The quote from Louise Newson's website is perfect. 
Title: Re: Vaginal progesterone inc Utrogestan, and endometrial protection: some studies
Post by: Hurdity on November 08, 2021, 08:07:54 AM
Bump for sfifties
Title: Re: Vaginal progesterone inc Utrogestan, and endometrial protection: some studies
Post by: Hurdity on June 11, 2022, 07:46:13 AM
Bump for jan1234
Title: Re: Vaginal progesterone inc Utrogestan, and endometrial protection: some studies
Post by: Hurdity on June 11, 2022, 07:46:56 AM
Also meant to add this paper by British Menopause Society which discusses vaginal use of Utrogestan as well:
https://thebms.org.uk/wp-content/uploads/2021/10/14-BMS-TfC-Progestogens-and-endometrial-protection-01H.pdf

Hurdity x
Title: Re: Vaginal progesterone inc Utrogestan, and endometrial protection: some studies
Post by: joziel on June 11, 2022, 10:01:48 AM
Please don't laugh at this anyone  ;D ;D ;D

But I was worried about the capsule dissolving okay vaginally so it could be absorbed (since it's designed to be taken orally). So I did a little test.. ;D

I put a capsule in a little glass of water and left it. I actually forgot about it for many hours. When I came back, the capsule was still undissolved in the glass. It had gone from being hard to being soft-shell and squishy, but I did have to squash it gently between my fingers before the progesterone inside came out.

Soooo, I'm now worried these oral capsules won't dissolve okay up there!?!?  :-\
Title: Re: Vaginal progesterone inc Utrogestan, and endometrial protection: some studies
Post by: Joaniepat on June 11, 2022, 11:36:00 AM
But bearing in mind the capsule will be inside you, wouldn't your body heat make a difference?
JP x
Title: Re: Vaginal progesterone inc Utrogestan, and endometrial protection: some studies
Post by: joziel on June 11, 2022, 01:50:05 PM
 ;D Maybe I should try it with warm water... will report back!!
Title: Re: Vaginal progesterone inc Utrogestan, and endometrial protection: some studies
Post by: Jan1234 on June 12, 2022, 06:06:57 PM
Hurdity thankyou for this i wondering now if perhaps i stick with ultrigeston vaginally now and just take it ever other night might help me with the bleeding and spotting im constantly getting
Title: Re: Vaginal progesterone inc Utrogestan, and endometrial protection: some studies
Post by: Hurdity on June 13, 2022, 07:35:27 AM
Please don't laugh at this anyone  ;D ;D ;D

But I was worried about the capsule dissolving okay vaginally so it could be absorbed (since it's designed to be taken orally). So I did a little test.. ;D

I put a capsule in a little glass of water and left it. I actually forgot about it for many hours. When I came back, the capsule was still undissolved in the glass. It had gone from being hard to being soft-shell and squishy, but I did have to squash it gently between my fingers before the progesterone inside came out.

Soooo, I'm now worried these oral capsules won't dissolve okay up there!?!?  :-\

Good idea there - but fortunately unnecessary! When we say that use of vaginal utrogestan for endometrial protection is unlicensed - this just means in the very strict sense that (absurdly) it is unlicensed for this use in UK.

Rest assured that:

1) Utrogestan (200mg capsules) is licensed for vaginal use for fertility treatment in UK
2) Utrogestan is manufactured for oral and vaginal use by Besins - I made a post on this and gave the translation from the French spc - which I will bump for you
3) Utrogestan 200 mg capsules used to be licensed for (oral) use as part of HRT but just with a different leaflet/packaging but withdrawn in favour of just the 100 mg capsules

You have nothing to fear about it not dissolving!

What is lacking are large studies looking into the effect of vaginal use on the endometriumm but the studdies quoted in this thread demonstrate what has been done, though I imagine there must have been work done by Besins also to allow licensing in France/other Europea countries (in fact this may well be quoted in the French product info but I didn't translate this part).

To emphasise that the French product info recommend the same  dose (as oral intake) to be used if taken vaginally, as does the BMS paper. Any recommendation otherwise is very much off-licence and seems to be used by some specialists - for women - under close supervision and monitoring.

As always it is important to be aware that the relationship between oestrogen and progestogen doses (in the context of endometrial protection) is dose dependent - ie higher doses of oestrogen are likely to require correspondingly higher doses of progestogen.

This is the thread:
https://www.menopausematters.co.uk/forum/index.php/topic,45782.0.html

Spot on also joaniepat....

Hope this helps :)

Hurdity x

Title: Re: Vaginal progesterone inc Utrogestan, and endometrial protection: some studies
Post by: joziel on June 13, 2022, 09:34:20 AM
Hurdity thanks!

Are you sure it's the exact same product (I mean, same additives and inactive ingredients) orally as vaginally?? I thought I'd looked into this and the vaginal pessary had different ingredients in it to the oral capsule.... Not the 200mg of utrogestan but the other inactive ingredients and excipients??
Title: Re: Vaginal progesterone inc Utrogestan, and endometrial protection: some studies
Post by: Hurdity on June 14, 2022, 07:38:41 AM
Yes that is my understanding.

Check out the thread I linked to - relevant information quoted here:

"In the French database of medicines (the "base de donnees publique des medicaments") this product is listed as: "UTROGESTAN 100 mg, capsule molle orale ou vaginale " (soft oral or vaginal capsule) - similarly for 200 mg.  In the info it gives the indication for vaginal route, amongst other uses, if side effects are experienced with oral use:

"Dans toutes les autres indications de la progestérone, la voie vaginale représente une alternative à la voie orale en cas:

• d'effets secondaires dus à la progestérone (somnolence après absorption par voie orale)."

Translation: In all other indications of progesterone, the vaginal route respresents an alternative to the oral route in the case:
.. of  side effects due to the progesterone (sleepiness after absorption by the oral route).
"

(Strange symbols due to change in forum software I think which affected older posts....)

Excipients the same - just less detail in the 100 mg

https://www.medicines.org.uk/emc/product/352/smpc#gref
6.1 List of excipients
Sunflower oil, refined
Soybean lecithin
Gelatin
Glycerol
Titanium dioxide
Purified water

https://www.medicines.org.uk/emc/product/3244/smpc
200 vag
Capsule contents:
Sunflower oil, refined
Soybean lecithin
Capsule shell:
Gelatin Glycerol
Titanium dioxide (E171)
Water, purified


Hope this helps :)

Hurdity x
Title: Re: Vaginal progesterone inc Utrogestan, and endometrial protection: some studies
Post by: joziel on June 14, 2022, 12:31:23 PM
Thanks, that's great. I wish they'd stop putting titanium dioxide in almost every medicine though. It's not great for us and we are supposed to avoid it as a food additive so it sucks we are then forced to consume it every day forevermore in meds...
Title: Re: Vaginal progesterone inc Utrogestan, and endometrial protection: some studies
Post by: Hurdity on August 06, 2022, 09:24:20 AM
bump for sherbet
Title: Re: Vaginal progesterone inc Utrogestan, and endometrial protection: some studies
Post by: violetbat on August 07, 2022, 08:50:23 AM
Thanks lady.
I didnt know of anyone else using 200 vaginally. So you've  answered my question.

Think I will use 200 to be safe side.

Xxxx

I am on Everol 100- before that 4 pumps of gel
I choose to use 200mg vaginally for 12 days a month just to be on the safe side. Some months the side effects are miserable- mostly pmt like cramping and crappy mood the entire time-other months it’s not an issue. Wish it helped me sleep though!
Title: Re: Vaginal progesterone inc Utrogestan, and endometrial protection: some studies
Post by: Hurdity on November 13, 2022, 08:47:25 PM
bump for chucklesista
Title: Re: Vaginal progesterone inc Utrogestan, and endometrial protection: some studies
Post by: Furyan on January 24, 2023, 06:55:30 PM
Thanks Hurdity for collating the relevant research into one thread and for all replies since. Helpful to see the key research in one place to compare with one another and my own ‘experiments’. I recently asked my GP to switch me from Evorel Conti (which I cut in half) to Evorel 25 combined with 100mg Utro. Mainly because it didn’t sit right with me to be taking synthetic P.

Anyway, I took Utro vaginally every 3 days and felt fine. But three weeks in I started to spot so, as per previous specialist advice, changed to vaginally every other day. Symptoms wise, no difference as I’m fine HOWEVER a week later and heavy spotting continues - like a lightish period. This is new to me as, of the various regimes I tried over the past year, I haven’t had any bleeding apart from when once trying to stop estrogen.

I should say - I’ve been a little erratic since starting HRT and haven’t taken estrogen consistently as I originally thought it could be causing all the weight gain, bloating etc which depressed me.

So, is it normal to bleed when we change HRT regime? I’m thinking I couldn't have built up much lining surely, as never taken estrogen alone and I’m on such a low dose? Getting paranoid  :-\

Once again, thanks ladies for sharing your honest and ‘real’ experiences - kinda comforting through this dark HRT minefield x
Title: Re: Vaginal progesterone inc Utrogestan, and endometrial protection: some studies
Post by: Furyan on January 24, 2023, 07:00:41 PM
Oh - and I read elsewhere several times that the bleeding could be due to high progesterone to estrogen ratio. Given the research posted to this thread, I would have thought that 100 vaginally every other day would be fine for a low estrogen dose like that supplied through Evorel 25? Or maybe it’s too much!
Title: Re: Vaginal progesterone inc Utrogestan, and endometrial protection: some studies
Post by: Mary G on January 24, 2023, 09:33:55 PM
Furyan,  if you are using a 25mcg patch then 100mg vaginal Utrogestan every other day should be ample ie equivalent to 50mg progesterone every day.   

I'm using one generous pump of Oestrogel with 50mg progesterone every day and my womb lining is below the 5mm danger line for a continuous combined regime.

Title: Re: Vaginal progesterone inc Utrogestan, and endometrial protection: some studies
Post by: Furyan on January 25, 2023, 09:07:45 PM
Hi Mary G - thanks for your reply. That’s what I initially thought but your reply is very reassuring because my patch dose is equivalent to your one pump of estrogen. Also hoping that my progest dose affords flexibility to increase the estrogen patch should I need to (which I hope I don’t!). My update today is that the spotting was much lighter today so I really hope it was all just a case of the body adjusting to the change in regime and I was just shedding unwanted lining. Here’s hoping for some consistency with our regimes from now!
Title: Re: Vaginal progesterone inc Utrogestan, and endometrial protection: some studies
Post by: Hurdity on June 04, 2023, 08:37:30 AM
Bump for Rufus657