Community Conversation => Transitioning => Hormone replacement therapy => Topic started by: AmandaDanielle on November 15, 2016, 11:31:14 PM Return to Full Version
Title: Injectable Estrogen Shortage
Post by: AmandaDanielle on November 15, 2016, 11:31:14 PM
Post by: AmandaDanielle on November 15, 2016, 11:31:14 PM
I am curious how many of my sister have been affected by this rather inconvenient estrogen shortage?
I recently had to switch to pills until the shortage is alleviated. I was hoping it would miss me but I guess not... Not impressed :(
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I recently had to switch to pills until the shortage is alleviated. I was hoping it would miss me but I guess not... Not impressed :(
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Title: Re: Injectable Estrogen Shortage
Post by: Sophia Sage on November 16, 2016, 07:36:41 AM
Post by: Sophia Sage on November 16, 2016, 07:36:41 AM
Estradiol Valerate is in shortage.
Estradiol Cypionate is still widely available. It's still injectable bio-identical estradiol, but the dosing is different, so check with your doctor. EC doesn't produce the same quick "spike" in serum levels, but on the other hand it has a longer duration.
Estradiol Cypionate is still widely available. It's still injectable bio-identical estradiol, but the dosing is different, so check with your doctor. EC doesn't produce the same quick "spike" in serum levels, but on the other hand it has a longer duration.
Title: Re: Injectable Estrogen Shortage
Post by: Janes Groove on November 16, 2016, 10:10:58 AM
Post by: Janes Groove on November 16, 2016, 10:10:58 AM
You can't get it for love or money. Maybe next March is what I've heard. I've noticed that breast tenderness has almost completely abated since I switched to the pills. Which should be a good thing, right? Except it probably means breast growth has slowed as well. I can't wait for it to be back on the market.
Title: Re: Injectable Estrogen Shortage
Post by: JoanneB on November 16, 2016, 09:12:57 PM
Post by: JoanneB on November 16, 2016, 09:12:57 PM
Yet Again !!! >:(
I went through this a year or so ago. 10mg/ml was impossible. Finally 20mg/ml showed up after a month. And this was after going through some weeks of BS with Horizon BCBS and the infamous "Age or Gender" exclusion.
And now I am seeing a new doc next week for new scrip. Figures
Is this a regional or nationwide thing? I guess I'll check at my fav pharmacy tomorrow and see what they say
I went through this a year or so ago. 10mg/ml was impossible. Finally 20mg/ml showed up after a month. And this was after going through some weeks of BS with Horizon BCBS and the infamous "Age or Gender" exclusion.
And now I am seeing a new doc next week for new scrip. Figures
Is this a regional or nationwide thing? I guess I'll check at my fav pharmacy tomorrow and see what they say
Title: Re: Injectable Estrogen Shortage
Post by: Sophia Sage on November 16, 2016, 11:16:18 PM
Post by: Sophia Sage on November 16, 2016, 11:16:18 PM
First, please remember that injectable Estradiol Cypionate is still widely available, and it's the same bio-identical estradiol, just a different ester.
----------------------------------
Estradiol Valerate is in a national shortage. From the American Society of Health-System Pharmacists (http://www.ashp.org/menu/DrugShortages/CurrentShortages/bulletin.aspx?id=1186):
Estradiol Valerate Injection
[01 November 2016]
Products Affected - Description
Delestrogen injection, Par Sterile Products
10 mg/mL, 5 mL vial, 1 count (NDC 42023-0110-01)
20 mg/mL, 5 mL vial, 1 count (NDC 42023-0111-01)
40 mg/mL, 5 mL vial, 1 count (NDC 42023-0112-01)
Estradiol valerate injection, Perrigo
20 mg/mL, 5 mL vial, 1 count (NDC 00574-0870-05)
40 mg/mL, 5 mL vial, 1 count (NDC 00574-0872-05)
Reason for the Shortage
Par states the reason for the shortage is manufacturing delay.
Perrigo states the reason for the shortage is manufacturing issues.
Estimated Resupply Dates
Par Sterile Products has Delestrogen 10 mg/mL 5 ml vials, 20 mg/mL 5 mL vials, and 40 mg/mL 5 mL vials on back order and the company estimates a release date of 1st quarter 2017.
Perrigo has estradiol valerate 20 mg/mL 5 mL vials and 40 mg/mL 5 mL vials on back order and the company estimates a release date of mid-November 2016.
----------------------------------
Estradiol Valerate is in a national shortage. From the American Society of Health-System Pharmacists (http://www.ashp.org/menu/DrugShortages/CurrentShortages/bulletin.aspx?id=1186):
Estradiol Valerate Injection
[01 November 2016]
Products Affected - Description
Delestrogen injection, Par Sterile Products
10 mg/mL, 5 mL vial, 1 count (NDC 42023-0110-01)
20 mg/mL, 5 mL vial, 1 count (NDC 42023-0111-01)
40 mg/mL, 5 mL vial, 1 count (NDC 42023-0112-01)
Estradiol valerate injection, Perrigo
20 mg/mL, 5 mL vial, 1 count (NDC 00574-0870-05)
40 mg/mL, 5 mL vial, 1 count (NDC 00574-0872-05)
Reason for the Shortage
Par states the reason for the shortage is manufacturing delay.
Perrigo states the reason for the shortage is manufacturing issues.
Estimated Resupply Dates
Par Sterile Products has Delestrogen 10 mg/mL 5 ml vials, 20 mg/mL 5 mL vials, and 40 mg/mL 5 mL vials on back order and the company estimates a release date of 1st quarter 2017.
Perrigo has estradiol valerate 20 mg/mL 5 mL vials and 40 mg/mL 5 mL vials on back order and the company estimates a release date of mid-November 2016.
Title: Injectable Estrogen Shortage
Post by: bluepaint on November 17, 2016, 12:07:53 AM
Post by: bluepaint on November 17, 2016, 12:07:53 AM
Im so jealous, not of the shortage but that in the US you can even get it at all! Here in Canada its almost unheard of bc Its not available, it has been discontinued for many years (either e valerate or cypionate) and doctors in general dont want to talk about IM estrogen even if you find a compounding pharmacy to make ia generic version of E valerate for you!
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Title: Re: Injectable Estrogen Shortage
Post by: Chloe on November 17, 2016, 03:32:29 AM
Post by: Chloe on November 17, 2016, 03:32:29 AM
Quote from: Sophia Sage on November 16, 2016, 11:16:18 PM
Estradiol Valerate is in a national shortage.
Wow! The price you pay for being POPULAR ? It's a conspiracy! The new Republican Gov't is artificially creating a shortage by hording up all transgender ammunition! (lol sound familiar?)
Port Vila, Vanuatu still shows 10mg/ml Progynon Depot in stock. Been using sublingual Estrofem 2mg simply as maintenance for a while now, routine routine routine . . .
( ps: still annoyed the current Justice Dept/FBI won't let me buy a Henry Rifle (https://www.henryrifles.com/rifles/big-boy/) due long past 'protection orders' ? )
Title: Re: Injectable Estrogen Shortage
Post by: Wanda Jane on November 17, 2016, 08:55:09 AM
Post by: Wanda Jane on November 17, 2016, 08:55:09 AM
We had the same problem with EMS drugs in the US too. Over regulation of the pharmaceutical manufacturers caused many smaller ones to disappear causing the shortages as well as price gouging from lack of competition. Thanks big Gov! Here is a good place to get the true cause and expected return dates.
http://www.accessdata.fda.gov/scripts/drugshortages/default.cfm
http://www.accessdata.fda.gov/scripts/drugshortages/default.cfm
Title: Re: Injectable Estrogen Shortage
Post by: Sophia Sage on November 17, 2016, 11:02:13 AM
Post by: Sophia Sage on November 17, 2016, 11:02:13 AM
Quote from: Kiera on November 17, 2016, 03:32:29 AMWow! The price you pay for being POPULAR ? It's a conspiracy! The new Republican Gov't is artificially creating a shortage by hording up all transgender ammunition! (lol sound familiar?)
According to someone at a compounding pharmacy I spoke to (I think -- if I read it somewhere I can't find the link) the shortage is indeed a manufacturing issue. Something like the oil supply they used to suspend the estradiol ester in became contaminated at the source, so they want to use a different oil or oil supplier, but that in turn needs to go through the FDA, which of course means a slog through red tape.
QuotePort Vila, Vanuatu still shows 10mg/ml Progynon Depot in stock.
If you're not allergic to peanut oil, and don't live in the United States, sure...
Title: Re: Injectable Estrogen Shortage
Post by: Fresas con Nata on November 17, 2016, 01:05:13 PM
Post by: Fresas con Nata on November 17, 2016, 01:05:13 PM
Wow, interesting! I'm also reading about shortages in the twitter of a local (spanish) LGTBI association. I think it's for FtM stuff but still.
Title: Re: Injectable Estrogen Shortage
Post by: Janes Groove on November 17, 2016, 05:16:56 PM
Post by: Janes Groove on November 17, 2016, 05:16:56 PM
Quote from: Sophia Sage on November 16, 2016, 11:16:18 PM
Perrigo has estradiol valerate 20 mg/mL 5 mL vials and 40 mg/mL 5 mL vials on back order and the company estimates a release date of mid-November 2016.
That's what my pharmacist told me last month too.
And yet here we are.
Title: Re: Injectable Estrogen Shortage
Post by: TonyaW on November 17, 2016, 06:06:29 PM
Post by: TonyaW on November 17, 2016, 06:06:29 PM
Keep asking. I'm pharmacist and our wholesaler shows limited product in stock for both strengths.
They also list delays in production, estimated availability late November. Those always seem to be overly optimistic from past experience.
My pharmacy only sells to nursing homes and I don't do the ordering so I can't help anyone out.
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They also list delays in production, estimated availability late November. Those always seem to be overly optimistic from past experience.
My pharmacy only sells to nursing homes and I don't do the ordering so I can't help anyone out.
Sent from my SM-G930V using Tapatalk
Title: Re: Injectable Estrogen Shortage
Post by: Sydney_NYC on November 17, 2016, 09:55:41 PM
Post by: Sydney_NYC on November 17, 2016, 09:55:41 PM
Quote from: Sophia Sage on November 16, 2016, 11:16:18 PM
First, please remember that injectable Estradiol Cypionate is still widely available, and it's the same bio-identical estradiol, just a different ester.
----------------------------------
Estradiol Valerate is in a national shortage. From the American Society of Health-System Pharmacists (http://www.ashp.org/menu/DrugShortages/CurrentShortages/bulletin.aspx?id=1186):
Estradiol Valerate Injection
[01 November 2016]
Products Affected - Description
Delestrogen injection, Par Sterile Products
10 mg/mL, 5 mL vial, 1 count (NDC 42023-0110-01)
20 mg/mL, 5 mL vial, 1 count (NDC 42023-0111-01)
40 mg/mL, 5 mL vial, 1 count (NDC 42023-0112-01)
Estradiol valerate injection, Perrigo
20 mg/mL, 5 mL vial, 1 count (NDC 00574-0870-05)
40 mg/mL, 5 mL vial, 1 count (NDC 00574-0872-05)
Reason for the Shortage
Par states the reason for the shortage is manufacturing delay.
Perrigo states the reason for the shortage is manufacturing issues.
Estimated Resupply Dates
Par Sterile Products has Delestrogen 10 mg/mL 5 ml vials, 20 mg/mL 5 mL vials, and 40 mg/mL 5 mL vials on back order and the company estimates a release date of 1st quarter 2017.
Perrigo has estradiol valerate 20 mg/mL 5 mL vials and 40 mg/mL 5 mL vials on back order and the company estimates a release date of mid-November 2016.
Callen-Lorde has been told the same information. In the meantime been getting Estradiol Valerate through Anazao Health (a compounding Pharmacy that is FDA approved) their phone number is (800) 723-7455.
Their dosage only comes in 30mg/mL so you will have to adjust you dosage or injection times (my doctor gave me two options) and it costs $65 for a 5mL vial plus shipping. They don't deal with insurance so you have to pay up front and file with insurance company if they cover it. You just have to have your HRT doctor FAX a prescription to them at (800) 238-8239 and then call up and setup the first shipment. After that you can order re-fills online.
The only thing I wish they would do differently is that the vials they use are a dark brown and harder to see through and that makes it harder to see when your trying to get the last bit out, but they do come packed in a nice prescription bottle that makes traveling a little easier. The liquid itself looks the same at Delestrogen (or Estradiol Valerate) and has the same viscosity.
Title: Re: Injectable Estrogen Shortage
Post by: KayXo on November 17, 2016, 11:05:55 PM
Post by: KayXo on November 17, 2016, 11:05:55 PM
Quote from: bluepaint on November 17, 2016, 12:07:53 AM
Im so jealous, not of the shortage but that in the US you can even get it at all! Here in Canada its almost unheard of bc Its not available, it has been discontinued for many years (either e valerate or cypionate) and doctors in general dont want to talk about IM estrogen even if you find a compounding pharmacy to make ia generic version of E valerate for you!
I live in Canada and get it from a compounding pharmacy in Ontario. It works fine and they are very reliable. Approved by my three doctors. Don't see why doctors wouldn't want to consider this option...afraid of the unknown? Don't trust compounding pharmacies?
Title: Re: Injectable Estrogen Shortage
Post by: jentay1367 on November 18, 2016, 12:09:12 AM
Post by: jentay1367 on November 18, 2016, 12:09:12 AM
So I'm fascinated as to why anyone cares at all when cypionate is readily available. Same if not better efficacy with none of the grief of locating it. Just doesn't make any sensse at all to me.I pay 35.00 per month on a transformation dosage through a compounding pharmacy....so it cant be cost, right?
Title: Re: Injectable Estrogen Shortage
Post by: jentay1367 on November 18, 2016, 12:11:01 AM
Post by: jentay1367 on November 18, 2016, 12:11:01 AM
Quote from: bluepaint on November 17, 2016, 12:07:53 AM
Im so jealous, not of the shortage but that in the US you can even get it at all! Here in Canada its almost unheard of bc Its not available, it has been discontinued for many years (either e valerate or cypionate) and doctors in general dont want to talk about IM estrogen even if you find a compounding pharmacy to make ia generic version of E valerate for you!
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Hmmmmm, why do you suppose that is?
Title: Re: Injectable Estrogen Shortage
Post by: Sophia Sage on November 18, 2016, 08:30:24 AM
Post by: Sophia Sage on November 18, 2016, 08:30:24 AM
Quote from: jentay1367 on November 18, 2016, 12:09:12 AM
So I'm fascinated as to why anyone cares at all when cypionate is readily available. Same if not better efficacy with none of the grief of locating it. Just doesn't make any sensse at all to me.I pay 35.00 per month on a transformation dosage through a compounding pharmacy....so it cant be cost, right?
Back in the day, I remember on some board (or maybe on Usenet, hah! I've just dated myself) a Russian woman making the argument that injectable EV was more efficacious than EC (or anything else, for that matter). I don't remember the reasoning, though, or whether it was solid. The literature certainly suggests that EV yields much higher serum levels, but for shorter periods of time. Of course, that also depends on one's actual dose.
Title: Re: Injectable Estrogen Shortage
Post by: jentay1367 on November 18, 2016, 08:48:18 AM
Post by: jentay1367 on November 18, 2016, 08:48:18 AM
QuoteThe literature certainly suggests that EV yields much higher serum levels, but for shorter periods of time. Of course, that also depends on one's actual dose.
Isn't the important thing being your personal numbers are where they should be? [I.E.] that your estrogen levels are maintained at a female level of around 200 pg/mol? What difference would any of the efficacy argument matter if your numbers are good?
Title: Re: Injectable Estrogen Shortage
Post by: Sophia Sage on November 18, 2016, 09:10:44 AM
Post by: Sophia Sage on November 18, 2016, 09:10:44 AM
Quote from: jentay1367 on November 18, 2016, 08:48:18 AMIsn't the important thing being your personal numbers are where they should be? [I.E.] that your estrogen levels are maintained at a female level of around 200 pg/mol? What difference would any of the efficacy argument matter if your numbers are good?
I think it all depends.
The argument back in the day was to get serum numbers as high as your body would tolerate, to maximize efficacy of the estrogen. If that's how you're going to go, EV is certainly the drug of choice. I'm not sure if that's actually the case, though. It may be, though. Estrogen levels in puberty (when transformation actually takes place) tend to be all over the place, not at a steady number like we see in post-menopausal women on HRT. But whether this is actually a safe practice? I have no idea.
My biggest problem with EV was that after the peak was over, the drop was pretty psychologically hard, and I didn't want to inject every single week to mitigate that, and my endoc was concerned about how high my serum levels were. As to efficacy, I really don't know -- I was on HRT for only 10 or 11 months when I had facial surgery, and for only 18 months before SRS/BAS, and I didn't start injections until I was on pills for 3 months. However, even post-op and on EV injectables, my breast development did not increase much at all; I can thank BAS for most of what I have in that department. And when it comes to my face, frankly it was electrolysis that had the biggest impact.
So your mileage will vary.
For the last several years I was on the patch. I was not impressed, and recent lab results confirmed it -- estradiol didn't even break triple digits.
I've just taken my third EC shot, on a ten-day schedule. No significant mood swings, energy levels and libido have been good, and just the right about of acheyness in my breast. Far superior to the patch. It's still early, but it's looking pretty good for me as a long-term post-op maintenance dose, though obviously my needs are different now.
If I were young and just beginning transition, I'd probably go for EV injectable first, followed by EC.
Title: Re: Injectable Estrogen Shortage
Post by: KayXo on November 18, 2016, 11:58:11 AM
Post by: KayXo on November 18, 2016, 11:58:11 AM
Quote from: Sophia Sage on November 18, 2016, 08:30:24 AM
Back in the day, I remember on some board (or maybe on Usenet, hah! I've just dated myself) a Russian woman making the argument that injectable EV was more efficacious than EC (or anything else, for that matter). I don't remember the reasoning, though, or whether it was solid.
I think I know who you speak of and her assertion might have been that EV is actually 10 x less potent according to pharmaceutical recommendations and that it might be safer but it was recently discovered through more research that there shouldn't be much difference between EC and EV, both appear as potent and equally safe, relative to each other.
QuoteThe literature certainly suggests that EV yields much higher serum levels, but for shorter periods of time
Exactly that. Higher peaks but shorter duration with a half-life according to some studies of 4.5 days. EC's absorption is more prolonged with slightly lower peak levels, due to its longer ester chain such that it would appear injecting less frequently does not result in lows (i.e. PMS).
Quote from: jentay1367 on November 18, 2016, 08:48:18 AMIsn't the important thing being your personal numbers are where they should be? [I.E.] that your estrogen levels are maintained at a female level of around 200 pg/mol?
Not pg/mol but pg/ml (also in pmol/L outside the US).
Female levels actually fluctuate from as little as 20 pg/ml to up to 650 pg/ml during a single menstrual cycle and up to 75,000 pg/ml during pregnancy so that they are all over the place and even overlap the range of men (10-30). There is no such thing as a normal level, it would seem. Normal levels are arbitrarily set. The right level for one woman might be different for another. Common sense as we all differ in our responses, sensitivities due to genetics, metabolism, weight, age, hormonal environment, what we eat, drink and if we take other medications too.
Aust NZ J ObTtet Gvnaecol 1998. 38: 3: 45
"it is difficult to define a therapeutic drug concentration when considering implant therapy because patients may vary in their oestradiol requirements (...) In addition, serum oestradiol levels may not necessarily reflect tissue oestradiol levels."
CLIMACTERIC 2005;8(Suppl 1):3–63
"Even though there is a significant correlation between the serum concentrations of estradiol and their clinical effects, e.g. on hot flushes or bone mass, the serum level of an individual woman does not predict the therapeutic effect. As shown in Figure 1, the number of hot flushes differs largely in patients who showed identical estradiol levels during transdermal hormone therapy1. This casts considerable doubts on the usefulness of regular measurements of hormone levels for the prediction or control of a therapeutic success."
Again, just think for a moment. Does everyone react similarly to the same alcohol concentration in their blood or the same amounts of drugs in their bodies? No. That principle applies to hormone levels too.
Also, hormone levels fluctuate so that taking a measurement might not even be accurate, if there were even such a thing as an ideal level.
Maturitas, 12 (1990) 171-197
"When the serum concentrations of natural or synthetic sex steroids are measured at short time-intervals after administration and repeatedly during long-term treatment, it becomes obvious that there are large intra-individual and interindividual variations. This holds true for both the contraceptive steroids and the natural oestrogens and does not apply solely to the oral route. Long-term studies indicate that an important influence is exerted by predisposing factors, particularly the metabolic capacity of the liver, on the pharmacokinetics of sex steroids. Large variations in oestradiol and oestrone levels can be observed in an individual woman from day to day or from hour to hour, even during transdermal therapy with oestradiol"
I'm not a doctor but this makes sense to me. Discuss it with your doctors, as always and find out what they have to say.
Title: Re: Injectable Estrogen Shortage
Post by: jentay1367 on November 18, 2016, 02:39:43 PM
Post by: jentay1367 on November 18, 2016, 02:39:43 PM
QuoteFemale levels actually fluctuate from as little as 20 pg/ml to up to 650 pg/ml during a single menstrual cycle and up to 75,000 pg/ml during pregnancy so that they are all over the place and even overlap the range of men (10-30). There is no such thing as a normal level, it would seem. Normal levels are arbitrarily set. The right level for one woman might be different for another. Common sense as we all differ in our responses, sensitivities due to genetics, metabolism, weight, age, hormonal environment, what we eat, drink and if we take other medications too.
My Endo dropped my dosage by 33 percent after my test came back 305 pg/ml. She told me those levels were too high and she wanted them down. Since that occurred (about 2 months ago) I've notice feminization has slowed and actually waned since the dosage change. Does this sound reasonable? I've been told that HRT doesn't work in a linear fashion, so I'm trying to be patient. On the other hand, I don't want to be spinning my wheels because she is over conservative. By the by....all my tests came back perfect, kidney, liver, cholesterol....etc...etc...perfect, that's what she said. My T was at 30 pg/ml. So I guess I'm a little concerned at this point that she's being overly conservative with the estradiol and slowing my progress unnecessarily. I've been on HRT for 6 months if this is of any help. Any feedback is welcome.....thanks. Lisa
Title: Re: Injectable Estrogen Shortage
Post by: KayXo on November 18, 2016, 03:22:10 PM
Post by: KayXo on November 18, 2016, 03:22:10 PM
Quote from: jentay1367 on November 18, 2016, 02:39:43 PMMy Endo dropped my dosage by 33 percent after my test came back 305 pg/ml. She told me those levels were too high and she wanted them down.
If you are taking bio-identical estradiol, especially non-orally,
consider the following:
Am J Obstet Gynecol. 1993 Dec;169(6):1549-53.
"As serum estradiol levels increased throughout each phase (maximum mean estradiol 739.8 pg/ml)"
"Down-regulation of the fibrinolytic system was observed as estradiol levels increased. However, thrombin formation did not change, thus suggesting that elevated circulating estradiol alone does not predispose to a thromboembolic event."
Br J Obstet Gynaecol. 1990 Oct;97(10):917-21.
"There is some anxiety about the possible harmful sequelae of supraphysiological estradiol levels but no data are currently available to show any deleterious effects of these levels on coagulation factors, blood pressure, glucose tolerance or the occurrences of endometrial or breast cancer (Hammond et al. 1974; Thom et id. 1978; Studd B Thom 1981; Armstrong 1988)."
"Supraphysiological oestradiol levels are an uncommon consequence of oestradiol implants (...) These high serum oestradiol levels were not associated with any deleterious effects and may be necessary for the control of symptoms in specific women"
"The mean serum oestradiol level of the 1388 women attending the clinic in 1988 was 767 pmol/l (range 78-2925 pmol/l), 66% had serum oestradiol levels <1000 pmol/l and 3% (38 women) had levels >1750 pmol/l (Fig 1)."
2925 pmol/L = 797 pg/ml
"The 15 women with PMS had a mean serum oestradiol of 2209 pmol/l (range 1760-2820 pmol/l). Their mean age at the start of treatment was 40 years (range 34-54) and the mean duration of therapy was 5.5 years (range 1-12)."
"The 23 menopausal women had a mean serum oestradiol of 2015 pmol/l (range 1785-2925 pmol/l). Their mean age was 46 years (range 29-58) and the mean duration of therapy was 4.5 years (range 1-10)."
Cancer. 2005 Feb 15;103(4):717-23.
"Patients with prostate
carcinoma progressing after primary hormonal therapy received TDE"
TDE = transdermal estrogen (high dose)
"The mean (+/-95% CI) serum estradiol level
increased from 17.2 pg.mL (range, 14.8-19.6 pg/mL) to 460.7 pg/mL
(range, 334.6-586.7 pg/mL)."
"No change in factor VIII activity, F 1.2, or
resistance to activated protein C was observed, whereas a modest
decrease in the protein S level was observed. CONCLUSIONS: In
patients with APIC, TDE was well tolerated and produced a modest
response rate, but was not associated with thromboembolic
complications or clinically important changes in several coagulation
factors."
Median age of patients was 75 (49-91).
J Urol. 2005 Aug;174(2):527-33; discussion 532-3.
"Levels of VIIa and XIIa were unaffected by transdermal estradiol therapy. Although levels of TAT III were increased in some patients at 12 months, the increase was markedly less than that observed historically with equivalent doses of oral estrogens. Levels of the inhibitory and fibrinolytic factors including protein C, protein S, APC-R, TPA and PAI-1 remained stable. Reductions in F1+F2, fibrinogen and D-Dimer levels represented a normalization from increased levels to the physiological range."
"These results suggest that transdermal estradiol reduces thrombophilic activation in men with advanced prostate cancer, and protects against the risk of thrombosis."
J Lipid Res. 2006 Feb;47(2):349-55.
"This prospective pilot study of 18 men with androgen-independent prostate cancer receiving ADT measured effects of TDE on lipid and inflammatory CVD risk factors before and after 8 weeks of TDE (...). During treatment, estradiol levels rose 17-fold; total cholesterol, LDL cholesterol, and apolipoprotein B levels decreased. HDL2 cholesterol increased, with no changes in triglyceride or VLDL cholesterol levels. Dense LDL cholesterol decreased and LDL buoyancy increased in association with a decrease in HL activity. Highly sensitive C-reactive protein levels and other inflammatory markers did not worsen. Compared with ADT, short-term TDE therapy of prostate cancer improves lipid levels without deterioration of CVD-associated inflammatory markers and may, on longer-term follow-up, improve CVD and mortality rates."
TDE = transdermal estradiol
ADT = androgen deprivation therapy
Horm Metab Res. 1994 Sep;26(9):428-31.
"Thirteen osteopenic women received (...) estradiol valerate and (...) hydroxyprogesterone caproate by intramuscular injections once a week for 6 months (so called "pseudopregnancy")."
"Six patients were peri- or postmenopausal (49.5 + 4.8 years of age, group A)"
"The duration of the therapy was 6, and in 4 patients 9 months"
"Estradiol increased from 34.8 +/- 7.5 pg/ml to 3226 +/- 393 pg/ml after 3 months and to 2552 +/- 254 pg/ml after 6 months, respectively, in group A."
"Investigations of lipids, liver enzymes and haemostasiology to be published later will show the absence of unwanted metabolic effects of this regimen."
"In conclusion, our data show, that the treatment (...) by means of high parenteral estrogen-progestogen depot injections is effective. Virtually no side effects occurred. The therapy is well accepted by the patients."
Aust NZ J ObTtet Gvnaecol 1998. 38: 3: 455
"The long-term effects of a steadily increasing oestradiol baseline on body weight have been investigated by Barlow et a1 (6) who failed to demonstrate significant changes in mean weight, blood pressure or liver function in their patients during 3 years of implant treatment."
CLIMACTERIC 2005;8(Suppl 1):3–63
"In women with supraphysiological estradiol levels during treatment with implants, no adverse effects on lipid metabolism, but a reduction in LDL cholesterol and fasting insulin were observed."
Obstet Gynecol. 2015 Mar;125(3):605-10.
"In transgender women, estrogen therapy, with or without antiandrogen therapy, was associated with lower BP."
"Transgender women (persons assigned male at birth, but who identify as females and who use estrogens with or without an anti-androgen to develop female secondary sex characteristics) had normal median baseline and 6 month body mass index (24.8 kg/m2 (IQR=4.3) and 23 kg/m2 (IQR=4.5) respectively). Both systolic and diastolic median blood pressures in this group dropped significantly from baseline to 6 months (130.5 mmHg (IQR 11.5) to 120.5 mmHg (IQR 15.5) p=.006; 78 mmHg (IQR 21) to 67 mmHg (IQR 12), p=.001 respectively)."
"All transgender women had estradiol levels at least in the physiologic female – range at 6 months, with 3/16 (19%) having supraphysiologic levels > 1000pg/dl (including the one transgender woman using intramuscular estradiol valerate). At 6 months, free testosterone was in the female physiologic range in 14/15 (93%), however only 10/15 (66%) had total testosterone levels in the female physiologic range (Table 4)."
Typo: instead of pg/dl, should be pg/ml.
Regarding breast cancer or cancer in general,
Journal of Clinical & Translational Endocrinology 2 (2015) 55-60
"There is no increase in cancer prevalence or mortality due to transgender HT."
"While some guidelines for transgender medical care express concerns for elevated cancer risk with certain hormone regimes, current data suggest that the risk of cancer may not rise."
"Although studies are small, overall cancer incidence in transgender men and transgender women to-date has not been found to be different than their respective male and female controls [5]. There are no reports of change in breast cancer specific risk among transgender individuals on estrogen compared to secular trends of male breast cancer incidence. Rates are lower relative to secular trends of female breast cancer rates."
This, despite the use of very high doses of estrogen for the larger part of the 20th century (after 1950-1960).
Regarding prolactinoma,
Andrologia. 2015 Aug;47(6):680-4.
"Prolactinomas in oestrogen-treated MtoF persons are rare. In the Amsterdam Gender Clinic between 1975 and
2006, 2306 MtoF transsexual subjects were treated. The mean age at initiation of treatment was 29.3 12.7 years,
with a range of 16–83 years. Mean follow-up in these subjects was 21.4 years, providing a total of 51 173 person-years of exposure and follow-up. Follow-up of 20 years or more was available of 303 individuals, including follow-up of 30 years or greater in 151. In this population, only one case of a prolactinoma was encountered."
"In Trangender Clinic of Hospital das Clınicas, at the Medical School of University of Sao Paulo, 166 MtoF transsexuals have been followed since 1996. Unsupervised use of oestrogens was estimated in 88.2% of the total cases. The mean age at initiation of oestrogen use was 21.4 7.2 years, with a duration of oestrogen administration ranging from 9 to 48 years. In this population, abuse of injectable hormones was noted sometimes in combination with oral oestrogens. (...) Even though the majority of subjects followed at our clinic have used extremely high doses of oestrogen during several years, the frequency of prolactinomas in our group was very low. This was also the case in the Amsterdam gender clinic in subjects who had used very high doses of oestrogens."
Share this with your doctor, see what she has to say. :)
Title: Re: Injectable Estrogen Shortage
Post by: jentay1367 on November 18, 2016, 04:01:04 PM
Post by: jentay1367 on November 18, 2016, 04:01:04 PM
Thanks Kay....as usual, you're an awesome wealth of information. I'm going to show this info to my Endo next trip in and have a discussion if my progress is still feeling stalled. You rock girl....!
Title: Re: Injectable Estrogen Shortage
Post by: Josilyn on November 18, 2016, 10:27:10 PM
Post by: Josilyn on November 18, 2016, 10:27:10 PM
My doc is switching me to injections. Being that there is a shortage, how difficult is it really to get filled if they are prescribing the Estridiol Valerate?
Title: Re: Injectable Estrogen Shortage
Post by: JoanneB on November 19, 2016, 07:17:22 AM
Post by: JoanneB on November 19, 2016, 07:17:22 AM
Under normal circumstances it's not a big deal at all to get filled. The worse is perhaps needing to wait a day for the pharmacy to get it in from their distributor. Unlike many meds it's not typically sitting on shelf.
For whatever reasons there seems to be these periodic shortages. In practice in the US there are two "Real" manufacturers and I think 3 others OK'd by the FDA. So some common supply chain root cause like getting the oil sort of makes sense in an academic sense
For whatever reasons there seems to be these periodic shortages. In practice in the US there are two "Real" manufacturers and I think 3 others OK'd by the FDA. So some common supply chain root cause like getting the oil sort of makes sense in an academic sense
Title: Injectable Estrogen Shortage
Post by: bluepaint on November 19, 2016, 01:17:43 PM
Post by: bluepaint on November 19, 2016, 01:17:43 PM
When I transitioned back in 92, I had been taking Delestrogen, it was readily available and I had very smooth few years with good results then when I needed to go through the gatekeepers to be referred for GCS , the gender clinic's endo. back then moved me to estinyl (which was recommended bc they said was better for feminization) we all know how bad that was! Ive been on patches and in recent years Estrace. The best thing about the IM e valerate is it being parenteral it doesn't raises shbg and crp like the oral estradiol does and its something i feel would be better for me especially now that im getting older. I found an pharmacy that can compound e valerate, just in the process of finding a supportive endo or gyn, my family doc prescribes the Estrace but is uncomfortable with injections.
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Title: Re: Injectable Estrogen Shortage
Post by: KayXo on November 20, 2016, 09:30:40 PM
Post by: KayXo on November 20, 2016, 09:30:40 PM
Quote from: bluepaint on November 19, 2016, 01:17:43 PM
When I transitioned back in 92, I had been taking Delestrogen, it was readily available and I had very smooth few years with good results then when I needed to go through the gatekeepers to be referred for GCS , the gender clinic's endo. back then moved me to estinyl (which was recommended bc they said was better for feminization) we all know how bad that was!
This just goes to show you that just because you are being followed by a doctor does not guarantee you are given a safe treatment. This doctor actually did more harm than good by prescribing a form of estrogen which has shown to raise thromboembolism risks to a greater degree than bio-identical estrogen and asserted it was better than feminization. To be fair though, the information provided below was probably not available to the doctor at the time so I assume they did what they did with the best of intentions and basing themselves on what they knew at the time. Doctors are human too and we must be indulgent to a certain degree. :)
Please note I am NOT condoning self-medication. Being under a doctor's care is the safest route if anything bad should happen and most of the time, a competent and knowledgeable physician will prescribe what is best for you. BUT, doing your own research as well and becoming proactive in your treatment is an additional insurance, just in case. You never know, it can happen, doctors aren't infallible. Find a good doctor but be aware too. ;)
Curr Opin Endocrinol Diabetes Obes. 2013 Dec;20(6):565-9.
« Nowadays, both ethinyl estradiol and CEE are not recommended and should not be prescribed [3–6,7&&,8,9& ,10–13] due to clinical evidence which showed a relationship between the use of ethinyl estradiol and a significantly higher incidence of thrombotic events [15] when compared to oestrogens like estradiol valerate or estradiol [9& ,10,11,15]."
"Although no direct comparison of different oestrogen formulations has been reported, preliminary observations suggest that there is no significant difference in the efficacy of different oestrogen formulations in terms of breast development, body shaping or bone metabolism [8]. Therefore, the use of adequately safe oestrogen doses and formulations is mandatory to optimize safety of these treatments."
QuoteThe best thing about the IM e valerate is it being parenteral it doesn't raises shbg and crp like the oral estradiol does
That depends on the dose. On IM EV, my CRP and SHBG are actually higher but CRP remains within normal range relative to when I was on oral E.
Title: Injectable Estrogen Shortage
Post by: bluepaint on November 20, 2016, 10:01:02 PM
Post by: bluepaint on November 20, 2016, 10:01:02 PM
there are some very good HRT forums out there , that give out good information based on fact and not just anecdotal evidence!
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Title: Re: Injectable Estrogen Shortage
Post by: Janes Groove on November 22, 2016, 06:28:14 PM
Post by: Janes Groove on November 22, 2016, 06:28:14 PM
Hooray! I bought injectable estradiol valerate at Walmart today.
The drought is over.
The drought is over.
Title: Re: Injectable Estrogen Shortage
Post by: DanaDane on November 22, 2016, 06:36:35 PM
Post by: DanaDane on November 22, 2016, 06:36:35 PM
Quote from: Sophia Sage on November 18, 2016, 09:10:44 AM
For the last several years I was on the patch. I was not impressed, and recent lab results confirmed it -- estradiol didn't even break triple digits.
I guess I'm the weird with Patches. In 9 months I went up to 363. I was doing double patches (0.1x2 twice a week). I've now moved on to EV and now thanks to the shortage EC. I'm due to get my levels checked..
Title: Re: Injectable Estrogen Shortage
Post by: JoanneB on November 22, 2016, 08:12:25 PM
Post by: JoanneB on November 22, 2016, 08:12:25 PM
I just checked with my usual pharmacy (Walgreens), and today just before my doc appointment was told "30 Nov".
My doc new (first appoint with him) knew of the "Shortage" and had the same opinion as me (also versed in the medicial arts) Utter BS. His read is another "Epi Pen" maneuver since now pretty much the entier USA market is locked up by one company. >:(
He wasn't too confident about about being able to get Estradiol Cyponate. On the plus side he dislikes pills as much as I do
My doc new (first appoint with him) knew of the "Shortage" and had the same opinion as me (also versed in the medicial arts) Utter BS. His read is another "Epi Pen" maneuver since now pretty much the entier USA market is locked up by one company. >:(
He wasn't too confident about about being able to get Estradiol Cyponate. On the plus side he dislikes pills as much as I do
Title: Re: Injectable Estrogen Shortage
Post by: jentay1367 on November 22, 2016, 11:08:50 PM
Post by: jentay1367 on November 22, 2016, 11:08:50 PM
Quote from: JoanneB on November 22, 2016, 08:12:25 PM
I just checked with my usual pharmacy (Walgreens), and today just before my doc appointment was told "30 Nov".
My doc new (first appoint with him) knew of the "Shortage" and had the same opinion as me (also versed in the medicial arts) Utter BS. His read is another "Epi Pen" maneuver since now pretty much the entier USA market is locked up by one company. >:(
He wasn't too confident about about being able to get Estradiol Cyponate. On the plus side he dislikes pills as much as I do
This is who I use.....
https://compoundingrxusa.com
I've yet to have an issue filling anything. Prices are ridiculously low for IM Estradiol. Good Luck
Title: Re: Injectable Estrogen Shortage
Post by: TonyaW on November 22, 2016, 11:15:32 PM
Post by: TonyaW on November 22, 2016, 11:15:32 PM
Quote from: JoanneB on November 22, 2016, 08:12:25 PMDon't think this one is a Epi-pen like issue. That was pretty much one manufacturer that jacked up the price.
I just checked with my usual pharmacy (Walgreens), and today just before my doc appointment was told "30 Nov".
My doc new (first appoint with him) knew of the "Shortage" and had the same opinion as me (also versed in the medicial arts) Utter BS. His read is another "Epi Pen" maneuver since now pretty much the entier USA market is locked up by one company. >:(
He wasn't too confident about about being able to get Estradiol Cyponate. On the plus side he dislikes pills as much as I do
I believe there are two US manufacturers and not really a high demand product. One maker has some production problems and runs out so everyone buys up the rest of the other manufacturer's products and then everyone is out. If the timing was right (or wrong, depending how you look at it) then none is scheduled to be made for a while. It takes some time to get production going again, a low demand item like this wouldn't be in constant production.
I haven't looked recently but don't recall any issues with getting the cyprionate form.
Title: Injectable Estrogen Shortage
Post by: bluepaint on November 23, 2016, 12:15:55 AM
Post by: bluepaint on November 23, 2016, 12:15:55 AM
Because we had waves of bad pr in regards to estrogen in general a few years ago in regard to treating cis women, I think there was no longer a demand for the product. Here in Canada companies here even discontinued it completely (both e valerate and cypionate) bc it wasn't being prescribed by doctors but now with the large population of trans women and trans feminine persons, that might change now that theres a bigger demand for it! Im sure if theres a market , companies will try to supply! lol
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Title: Re: Injectable Estrogen Shortage
Post by: Dena on November 23, 2016, 12:23:05 AM
Post by: Dena on November 23, 2016, 12:23:05 AM
Valerate is only made by one company but others buy it in bulk and use it to produce their products. If the main factory has an issue, the whole supply chain gets fouled up. Plain estradiol isn't patented because it a natural product and patents are not issued for something preexisting so multiple companies can produce it thus few supply chain issues.
Title: Re: Injectable Estrogen Shortage
Post by: JoanneB on November 23, 2016, 08:14:53 PM
Post by: JoanneB on November 23, 2016, 08:14:53 PM
Quote from: jentay1367 on November 22, 2016, 11:08:50 PMUnfortunately the deeply blue "We know what's Best (for our pockets) state of NJ will not allow out of state pharmacies. During the last "Shortage" I saw that Stroeheckers said "Nyet". Ironically my alternate address in WV feels the same :( The copay for the EV would be more then out of pocket for Stroeheckers's. Go Figure
This is who I use.....
https://compoundingrxusa.com
I've yet to have an issue filling anything. Prices are ridiculously low for IM Estradiol. Good Luck
Title: Re: Injectable Estrogen Shortage
Post by: jentay1367 on November 23, 2016, 09:21:50 PM
Post by: jentay1367 on November 23, 2016, 09:21:50 PM
The Nanny State sucks. I'm sorry to hear that, Joanne. >:(
Title: Re: Injectable Estrogen Shortage
Post by: SadieBlake on November 26, 2016, 07:39:20 AM
Post by: SadieBlake on November 26, 2016, 07:39:20 AM
Good news that the Perrigo is back in supply! I was fine as my dosage is so small a 5ml vial lasts half a year and hearing about the shortage I picked up an extra JIC. I've since sent that extra off to a friend who'd run out.
As to nanny state, I've spent 30+ years working in medical device and pharmaceutical design and manufacture. With all due respect to my colleagues, this is an area that needs oversight. I say this as someone with absolutely no love for how the FDA operates however the alternative doesn't bear consideration.
I've seen too many instances of people knowingly violating patient safety even in the heavily regulated environment. People are short sighted and sadly the pressure to meet quarterly earnings can and does affect product quality.
As to nanny state, I've spent 30+ years working in medical device and pharmaceutical design and manufacture. With all due respect to my colleagues, this is an area that needs oversight. I say this as someone with absolutely no love for how the FDA operates however the alternative doesn't bear consideration.
I've seen too many instances of people knowingly violating patient safety even in the heavily regulated environment. People are short sighted and sadly the pressure to meet quarterly earnings can and does affect product quality.