Success stories for managing TRT induced increase in hematocrit?

[Michael D]

This is key as lowering one's overall TT/FT levels will have the biggest impact but the main issue is finding the lowest TT/FT level you can run without losing all of the beneficial effects of testosterone.

Although switching to daily using lower dose of T may work for some it is not a given and the downfall in many cases is these same individuals that tend to struggle with elevated RBCs/hemoglobin/hematocrit are still running absurdly high TT/FT levels!

Are you suggesting those with continued elevated RBC, etc, are not not really lowering their T dose? I have reduced mine by half, so I'm hoping for a good result.

 

[madman]

Are you suggesting those with continued elevated RBC, etc, are not not really lowering their T dose? I have reduced mine by half, so I'm hoping for a good result.

Some tend to keep the weekly dose the same when injecting daily but most use a lower overall weekly dose and in such cases unfortunately their daily dose of T is still too high leading to absurdly high TT/FT levels.

 

[Michael D]

Some tend to keep the weekly dose the same when injecting daily but most use a lower overall weekly dose and in such cases unfortunately their daily dose of T is still too high leading to absurdly high TT/FT levels.

Got it...thanks for the clarification. So the take-home message is that lowering the dose and spreading it out more evenly does not work for everyone!

 

[UCFguy01]

Some tend to keep the weekly dose the same when injecting daily but most use a lower overall weekly dose and in such cases unfortunately their daily dose of T is still too high leading to absurdly high TT/FT levels.

My levels are between 1200 - 1400. Not sure if this is absurd but it's high and I feel good. I do 25mg a day.

 

[madman]

My levels are between 1200 - 1400. Not sure if this is absurd but it's high and I feel good. I do 25mg a day.

Which is it 1200 ng/dL (42 nmol/L) or 1400 ng/dL (49 nmol/L) as a 200 ng/dL difference is huge and will have a big impact on your FT.

1400-1500 ng/dL would have most men's FT through the roof.

As long as you are not struggling to manage elevated RBC's/hemoglobin/hematocrit or sides than I see no issue.

If one were then they would easily have room to lower their dose slightly.

 

[Michael D]

I thought I would give an update to this thread. For months I've been taking much lower doses of T cypionate and lowered my T from 900-1000 to 450. I also underwent 3 rounds of phlebotomy to get my hematocrit and hemoglobin counts into the normal range. But since then every set of labs I've done has shown a gradual increase in hematocrit and hemoglobin, putting me back to where I started. It's very frustrating, to say the least.

Last week I consulted with a different Dr., who honestly seemed to know nothing about this issue, but she prescribed me daily T troches instead of injections. I've started that, but I've never read that doing this will help...so I have no confidence. I came across the attached article that describes a regime of clomiphene citrate and HCG to raise T levels; does anyone know if this treatment might avoid polycythemia?

There are no Dr's here in Hawaii that have any experience with this sort of thing. I have very good insurance that will pay for a Dr. on the mainland. If anyone has a good Dr. they could recommend...I'm all ears.

 

[Fernando Almaguer]

I thought I would give an update to this thread. For months I've been taking much lower doses of T cypionate and lowered my T from 900-1000 to 450. I also underwent 3 rounds of phlebotomy to get my hematocrit and hemoglobin counts into the normal range. But since then every set of labs I've done has shown a gradual increase in hematocrit and hemoglobin, putting me back to where I started. It's very frustrating, to say the least.

Last week I consulted with a different Dr., who honestly seemed to know nothing about this issue, but she prescribed me daily T troches instead of injections. I've started that, but I've never read that doing this will help...so I have no confidence. I came across the attached article that describes a regime of clomiphene citrate and HCG to raise T levels; does anyone know if this treatment might avoid polycythemia?

There are no Dr's here in Hawaii that have any experience with this sort of thing. I have very good insurance that will pay for a Dr. on the mainland. If anyone has a good Dr. they could recommend...I'm all ears.

What are you hct levels and what side effects do you experience from high level?

 

[Michael D]

HCT was 55 when my doc prescribed 3 rounds of phlebotomy in a 2 week period. That brought me down to 45, now it's back up to 52, and I suspect it's just going to keep going up. I didn't have any readily identifiable symptoms, but that said, I probably was walking around with those high levels for many years (I've been on TRT for 7 years, but my previous doc never checked!). In retrospect, I did have quite a bit of ringing in my ears and odd headaches...and that seems to have gone away.

 

[Cataceous]

What's your current protocol? If you're injecting infrequently then even a trough serum testosterone in the 400s ng/dL could still mean a peak over 1,000 ng/dL, well over what the vast majority of men have naturally.

 

[Michael D]

I inject once per week. I've been given daily troches...maybe that will work better? Also, no one here seems to be able to answer my question as to whether daily clomids would avoid the elevated hematocrit? Is clomid a viable option for TRT?

 

[Cataceous]

I inject once per week. I've been given daily troches...maybe that will work better? Also, no one here seems to be able to answer my question as to whether daily clomids would avoid the elevated hematocrit? Is clomid a viable option for TRT?

I can't comment on the troches because I don't know their pharmacokinetics.

Clomid or any method of raising testosterone can often be dosed to avoid problems with hematocrit. I would suggest enclomiphene rather than Clomid. Empower Pharmacy ships to all 50 states, so if you can get a prescription then it's a viable option.

Alternatively, you can adjust your current protocol to possibly reduce hematocrit. Rough estimates put your peak testosterone at 1,100 ng/dL or more and your average level at 800 ng/dL. If I'm understanding you, you have cut your dose from 0.66 mL (132 mg?) T cypionate down to 0.33 mL (66 mg?). I would cut back a little to 0.08 mL (16 mg?) injected every other day. This should result in fairly stable serum T levels around what's typical for young men, 600-800 ng/dL. If this doesn't reduce hematocrit sufficiently then a final injection-based option is to experiment with daily doses of mixed esters.

 

[Michael D]

I can't comment on the troches because I don't know their pharmacokinetics.

Clomid or any method of raising testosterone can often be dosed to avoid problems with hematocrit. I would suggest enclomiphene rather than Clomid. Empower Pharmacy ships to all 50 states, so if you can get a prescription then it's a viable option.

Alternatively, you can adjust your current protocol to possibly reduce hematocrit. Rough estimates put your peak testosterone at 1,100 ng/dL or more and your average level at 800 ng/dL. If I'm understanding you, you have cut your dose from 0.66 mL (132 mg?) T cypionate down to 0.33 mL (66 mg?). I would cut back a little to 0.08 mL (16 mg?) injected every other day. This should result in fairly stable serum T levels around what's typical for young men, 600-800 ng/dL. If this doesn't reduce hematocrit sufficiently then a final injection-based option is to experiment with daily doses of mixed esters.

Many thanks for this. Since I'm a scientist by trade, I work best having numbers in front of me. One of the problems here, as I've explained, is that my Dr(s) have no clue how to manage any of this. They don't specify when to have my labs drawn (day of my injection, X-numbers day after my injection, etc). So looking at the lab results without this context makes it very difficult. Over the years I would often have them drawn the day before my shot, because I liked my results and didn't want them to reduce my dosage...but I had no idea my hematocrit was soaring.

Since I was just given these 80mg troches (and prescription says take one daily), I might try them...but instead, take 1/2 a troche every other day. Or maybe just cut them into quarters and take every day (10 mg/day). But is that still too much? It seems I was taking too much, without even knowing it.

 

[Cataceous]

...
Since I was just given these 80mg troches (and prescription says take one daily), I might try them...but instead, take 1/2 a troche every other day. Or maybe just cut them into quarters and take every day (10 mg/day). But is that still too much? It seems I was taking too much, without even knowing it.

I'm getting the sense that testosterone troches might behave a little like Natesto, the nasal testosterone gel. This would make it short acting and quite different from conventional TRT. If this is the case then the transition could be challenging. The idea behind Natesto is to supplement natural testosterone production rather than replace it. In your case it will take some time to restart natural production, and use of testosterone will slow down that restart. If this is what's expected then I'm not sure what kind of subjective experience you'll get from spiking testosterone a few times a day while having very low levels before doses and overnight.

Reported absorption rates for troches are quite variable, up to 50%, but as low as 10%.

Troches also exhibit poor pharmacokinetic parameters. This means that there are great fluctuations in hormone serum levels after taking a troche dose. Soon after taking a troche serum hormone levels rise rapidly, sometimes to very high levels, and then rapidly fall to low levels within 4 to 5 hours. They therefore require at least twice daily administration or for optimal results three to four times a day to maintain adequate levels longer however compliance becomes a major problem with this type of dosing schedule.​

[R]

 

[Michael D]

I'm getting the sense that testosterone troches might behave a little like Natesto, the nasal testosterone gel. This would make it short acting and quite different from conventional TRT. If this is the case then the transition could be challenging. The idea behind Natesto is to supplement natural testosterone production rather than replace it. In your case it will take some time to restart natural production, and use of testosterone will slow down that restart. If this is what's expected then I'm not sure what kind of subjective experience you'll get from spiking testosterone a few times a day while having very low levels before doses and overnight.

Reported absorption rates for troches are quite variable, up to 50%, but as low as 10%.

Troches also exhibit poor pharmacokinetic parameters. This means that there are great fluctuations in hormone serum levels after taking a troche dose. Soon after taking a troche serum hormone levels rise rapidly, sometimes to very high levels, and then rapidly fall to low levels within 4 to 5 hours. They therefore require at least twice daily administration or for optimal results three to four times a day to maintain adequate levels longer however compliance becomes a major problem with this type of dosing schedule.​

[R]

First, there is no re-starting my own T production. I'm taking T because my body quite making it in sufficient quantities. That was why I was asking about clomids, because I read they can stimulate more T production, even in with people that have hypogonadism (me). It doesn't hurt to start small, and slowly add more if I'm not having any hematocrit issues. I can try 1/4 of the troche (10 mg) twice daily. But you are saying that the injections release T more gradually, providing a more steady supply with less difference between peak and trough? At the very beginning of my TRT regime, 7 years ago, I did inject EOD. But that just got old...not so much the needle stick...but the remembering to do it.

If anyone out there is an experience MD in this field, I would appreciate being taken as a patient. Right now it's me and Google...then a conversation with my general practitioner where I try to educate him.

 

[madman]

I inject once per week. I've been given daily troches...maybe that will work better? Also, no one here seems to be able to answer my question as to whether daily clomids would avoid the elevated hematocrit? Is clomid a viable option for TRT?

Pharmacokinetics of big pharma buccal troche.




Testosterone Lozenges/Troches Each Striant™ lozenge (buccal system) comes in a blister pack. The lozenge must be kept in the blister pack until ready for use.

• Use: The lozenge has one flat side and one round side. The round side goes against the gums. The flat side goes against the cheek.

• When ready, put a lozenge in the mouth, start by putting the flat side of the lozenge on the fingertip. Place the lozenge up against the gums and to the left or right of the two front teeth. Gently push the lozenge up as high as it will go onto the gum. Take the finger out of the mouth and push on the lozenge from the outside of your upper lip for at least 30 s. The lozenge should stick to the gum. It is okay if it sticks to the cheek instead of the gum.

• Do not chew or swallow the lozenge. • Each time a new lozenge is used, put it on the side opposite from where the last lozenge was placed. If the morning lozenge was on the right side, put the evening lozenge on the left side.

• The lozenge will stay in the mouth all the time. It will get softer and slowly melt, but will not melt completely. It has to be removed after 12 h. Use the finger to gently loosen the lozenge. Then carefully slide it down along the tooth and take it out of the mouth.

• Unless changing lozenges, keep the lozenge in the mouth when eating or brushing the teeth. After eating or brushing the teeth, check to make sure the lozenge is still in place.

• Usual dose is two times a day, once in the morning and once in the evening (about 12 h apart). It may be easiest to put the lozenge on the gums after having eaten breakfast and brushing the teeth and after you have eaten the evening meal.




STRIANT® (testosterone buccal system)
mucoadhesive


DESCRIPTION

Striant® (testosterone buccal system) is designed to adhere to the gum or inner cheek. It provides a controlled and sustained release of testosterone through the buccal mucosa as the buccal system gradually hydrates. Insertion of Striant® twice a day, in the morning and in the evening, provides continuous systemic delivery of testosterone.

Striant® is a white to off-white colored, monoconvex, tablet-like, mucoadhesive buccal system. Striant® adheres to the gum tissue above the incisors, with the flat surface facing the cheek mucosa.

The active ingredient in Striant® is testosterone. Each buccal system contains 30 mg of testosterone. Testosterone USP is practically white crystalline powder chemically described as 17-beta hydroxyandrost-4-en-3one.

Other pharmacologically inactive ingredients in Striant® are anhydrous lactose NF, carbomer 934P, hypromellose USP, magnesium stearate NF, lactose monohydrate NF, polycarbophil USP, colloidal silicon dioxide NF, starch NF, and talc USP.


CLINICAL PHARMACOLOGY

Striant® delivers physiologic amounts of testosterone to the systemic circulation, thereby producing circulating testosterone concentrations in hypogonadal males that approximate physiologic levels seen in healthy young men (300 - 1050 ng/dL).


Pharmacokinetics

Absorption

When applied to the buccal mucosa, Striant® slowly releases testosterone, allowing for the absorption of testosterone through gum and cheek surfaces that are in contact with the buccal system. Since venous drainage from the mouth is to the superior vena cava, trans-buccal delivery of testosterone circumvents first-pass (hepatic) metabolism.

Following the initial application of Striant®, the serum testosterone concentration rises to a maximum within 10-12 hours. The mean maximum (C max ) and mean average serum total testosterone concentrations for the 12 hour dosing period (C avg(0-12) ) are within the normal physiologic range.

Striant® is intended for twice-daily dosing. Serum concentrations of testosterone reach steady-state levels after the second dose of twice-daily Striant® dosing. Following removal of Striant®, the serum testosterone concentration decreases to a level below the normal range within 2-4 hours.

With twice-daily repeated dosing, mean pharmacokinetic parameters at steady-state for total testosterone serum concentration were very similar between studies of 7-day and 12-week dosing durations. Mean C avg(0-24) across the studies ranged from 520 to 550 ng/dL and these mean values were within the physiologic range (see Table 1).


Table 1. Mean (±SD) Steady-State Serum Total Testosterone Concentrations During Treatment with Striant® (on Final Day of Treatment)

Although no specific food effect study was conducted, pivotal Phase 3 study results showed that the consumption of food and beverage did not significantly affect the absorption of testosterone from Striant®.

The effects of toothbrushing, mouth washing, chewing gum, and alcoholic beverages on the use and absorption of Striant® were not investigated in controlled studies, however, Phase 3 clinical studies permitted patients to do these activities indicating the use of Striant® was not significantly affected by these activities.



Clinical Studies

Striant® was evaluated in a multicenter, open-label, single-arm, Phase 3 trial in 98 hypogonadal men (Study 1). In this study, Striant® was administered twice daily for 12 weeks. The mean age was 53.6 years (range 20 to 75 years). Overall, 68 (69.4%) patients were Caucasian, 9 (9.2%) were African-American, 15 (15.3%) were Hispanic, 4 (4.1%) were Asian, and 2 (2.0%) were of another ethnic origin. At baseline, ten patients (10.2%) reported current use of tobacco, and forty-one (41.8%) drank alcohol. Of 82 patients who completed the trial and had sufficient data for full analysis, 86.6% had mean serum testosterone concentration (C avg(0-24) ) values within the physiologic range.

The mean (±SD) time-averaged steady-state daily testosterone concentration (C avg(0-24) ) at Week 12 was 520 (±205) ng/dL compared with a mean of 149 (±99) ng/dL at Baseline. At Week 12, the mean percentage of time over the 24-hour sampling period that total testosterone concentrations remained within the normal range of 300 - 1050 ng/dL was 76%. Table 1 above provides the steady-state serum testosterone concentrations in greater detail.

Striant® was also evaluated in a 7-day multicenter, open-label, parallel study comparing Striant® and an approved testosterone transdermal system (Study 2). In this study, Striant® was again administered twice daily. On Day 7, the mean C avg(0-24) for the 29 patients who received Striant® was 550 (±169) ng/dL compared with a mean of 119 (±78) ng/dL at Baseline. On Day 7, the mean percentage of time for Striant® over the 24-hour sampling period that testosterone concentrations remained within the physiologic range of 300-1050 ng/dL was 84%. Additional pharmacokinetic data for this study are presented in Table 1 above.

Figure 1 below shows the mean total testosterone serum concentration versus time at steady-state for two representative consecutive dosing intervals from both the 7-day and 12-week studies. The figure shows that the concentration-time curves for the different duration studies are consistent.


Figure 1: Mean (SD) total testosterone concentration-time curves for two consecutive dosing intervals at steady-state for both the 12- week study (Study 1) and the 7-day study (Study 2) of Striant®. (The horizontal dotted lines represent the upper and lower limit of normal for the normal physiologic range in healthy adult males).

In both clinical trials, mean DHT concentrations increased in parallel with testosterone concentrations, with the total testosterone/DHT ratio (9 - 12) indicating no alteration in the metabolism of testosterone to DHT in testosterone deficient men treated with Striant® as compared with young, healthy eugonadal men.

During continuous treatment, there was no accumulation of testosterone, and mean total testosterone, free testosterone, and DHT were maintained within their physiologic ranges.

 

[madman]

I inject once per week. I've been given daily troches...maybe that will work better? Also, no one here seems to be able to answer my question as to whether daily clomids would avoid the elevated hematocrit? Is clomid a viable option for TRT?

Many options when it comes to compounding.

 

[madman]

New Testosterone Buccal System (Striant) Delivers Physiological Testosterone Levels: Pharmacokinetics Study in Hypogonadal Men (2004)


*In conclusion, administration of T by buccal administration consistently maintained the mean serum T concentration within the physiologic range in most hypogonadal men. Because there is no dose adjustment, the one dose of 30 mg twice per day may provide insufficient or alternatively elevated serum T levels for some hypogonadal men. The application of the TBS caused mild to moderate gum irritation in some men that resulted in discontinuation in only 3% of subjects. The new dosage form was well accepted by the subject population. This novel T delivery system offers a viable alternative to the currently available methods for physiological replacement in hypogonadal men.

 

[magnus68]

Thanks for the success story. I'm hoping I can find a balance. This week I started logging my water intake and targeting 100 oz per day (3 L)...which is probably triple my typical intake. I tend to drink very little. That has made me feel better in many ways. After a few days the ringing in my ears stopped. I also had my first phlebotomy yesterday. I have one per week for 3-weeks. I asked if they will be testing iron and ferritin..."no." Oh well, part of the price of living in paradise! (poor health care). I'm reducing my T to 60mg/week and I'll see where I end up, and increase if I can. I won't have another set of labs to see my hematocrit level until after the 3rd phlebotomy.

You can purchase your own labs you know. Just order them yourself. plenty of info on this site.

 

[Starplex]

There are many different views on Hemocrit concerns, similar to E2 concerns. I'm not saying it's right, but a very well respected doc has told me not to be concerned with Hemocrit on TRT. His own values are 62 for several years and no issues, also on TRT.

I'm not saying I agree with it, just saying don't go tanking your ferritin (by donations) trying to achieve a value less than 52 or so.

As others have said a lower dose and more frequent injections should help. I recently lowered my dose to help with Hemocrit as well. Grapefruit juice and hydration tends to help as well.

You might see if Defy Medical will take you in as a patient.

 

[gerardo]

Does any of you have the experience of applying testosterone cypionate every other day (application every 2 days) compared to daily application? Did shbg, E2 and hematocrits make any difference?