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[possum]

Hey what does anyone think about this:

"The same Prometrium capsule can also be used vaginally, which would be advantageous for the few women who have side effects with the oral medication.  Essentially, the same gel cap is inserted into the vagina at night, where the gel cap melts and the sunflower oil runs to the back of the vagina.  Studies conducted in France have shown that natural progesterone is extremely well absorbed by the back of the vagina directly into the uterus.  This is so effective that in fact when Prometrium is used vaginally, it only needs to be used on Monday, Wednesday and Friday nights ie. three capsules a week separated by a day or two."

Taken from here: http://www.whria.com.au/co2-fractional-laser-treatment-for-vaginal-atrophy-4/. I know the title of that page looks weird, it's not reflective of the article's subject.

The author appears extremely credible (in fact I think my Dr recommended him as reference alllllll those months ago when he prescribed me and then I stubbornly refused to take it...umm...maybe I should be asking him about this instead...)  but I'm not sure on what evidence he is basing this suggestion. Nor how it applies to cyclic vs continuous HRT. But it's a pretty attractive proposition.

Oh, now I see it seems to be based on a French study...is anyone familiar with it by any chance? Because I'm feeling a need to track it down...this hrt thing is taking up so. much. time.

[Hurdity]

Hi possum

I've researched this info and posted about it several times - bit busy at the mo' but here it is - I've printed it all in full (there may be other studies):

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

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

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.

http://www.ncbi.nlm.nih.gov/pubmed/15222511

Efficacy of oral micronized progesterone when applied via vaginal route.
Choavaratana R1, Manoch D.
Author information
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).

http://www.ncbi.nlm.nih.gov/pubmed/20575654

Transdermal estradiol and oral or vaginal natural progesterone: bleeding patterns.
Di Carlo C1, Tommaselli GA, Gargano V, Savoia F, Bifulco G, Nappi C.
Author information
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.


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

"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)"
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
Cicinelli et al 2003

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.


The impact of micronized progesterone on the endometrium: a systematic review.

Stute P1, Neulen J2, Wildt L3.
Climacteric. 2016 Aug;19(4):316-28
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.

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

Endometrial Protection: Which Progestogen Is Best?
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

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.”


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


Hope this helps!

Hurdity  x

[Dancinggirl]

Isn't Hurdity great??  Comes up with the info we need.

possum - can I just emphasis that this study is based on women using a low-medium dose of oestrogen. Many women are on a higher dose of oestrogen, so a higher dose of progesterone and for more days would be needed.

Prometrium/Utrogestan is getting to be the most popular progesterone around these days and is deemed safer than many other synthetic progestones but it is far from perfect.  Side effects can be troublesome but then all progesterones can give problems.  Using it transdermally is also not ideal - you have to avoid sexual actively for a few hours while using it and some find it irritates the vaginal area and bladder (as I did).

If I were you, I'd try my suggestions on the other thread and see how it goes.  Don't start chopping and changing  - you have simply got off on teh wrong foot by taking the Prometrium straight off.  DG x

[possum]

Hi DG, you make some good points, thank you, and I totally concur with your suggestions on other thread...perfect plan. It's so invaluable having the benefit of your experience, can't tell you how much I appreciate it.

Thanks so much for sharing the links to those studies Hurdity, bit of light reading coming up!

[CLKD]

Bouncing for members with difficulty at the progesterone stage