Quantcast

Author Topic: Androxal ETA?  (Read 9139 times)

tomahawk

  • Jr. Member
  • **
  • Posts: 72
    • View Profile
Androxal ETA?
« on: September 03, 2015, 08:27:33 am »
hanging out for this
« Last Edit: September 03, 2015, 01:03:29 pm by PeakT »
37 Years old
super low SHBG, fatty liver, tracking to diabetes, high BP, adrenal fatigue
bio-identical cream
-hassle to do daily
Reandron 1000 (one shot every 3 months)
-mellow effects, all gone after 8 weeks, T down to 8, E to 181
Testosterone Cypionate
-25mg E3.5D, high blood pressure, headaches, insomnia
Came off Test Cyp.
Consider cold turkey..
A week later feel like crap, anxiety, poor sleep, waking up at 4am, fatigue 
10th April 2015 - back on Reandron 1000!
6 week injection protocol due to hypermetabolising

Arimidex 1mg twice a week (Mon and Thurs)
Myomin 2 pills with brekky, 2 pills with lunch, daily

PeakT

  • Administrator
  • Hero Member
  • *****
  • Posts: 38446
    • View Profile
    • Peak Testosterone
Re: Androxal ETA?
« Reply #1 on: September 03, 2015, 01:04:08 pm »
THE MOST COMPREHENSIVE BOOK ON TRT/TESTOSTERONE:
https://www.amazon.com/Natural-Versus-Testosterone-Therapy-Myer/dp/1523210532/ref=sr_1_1?ie=UTF8&qid=1499116128&sr=8-1&keywords=natural+versus+testosterone+therapy
And check out my New Peak Testosterone Program: http://www.peaktestosterone.com/peak_testosterone_program
If you are on medications or have a medical condition, always check with your doctor first before making any lifestyle changes or taking new supplements.  And low testosterone is a medical condition.

Peak Testosterone Forum

Re: Androxal ETA?
« Reply #1 on: September 03, 2015, 01:04:08 pm »


Osprey

  • Hero Member
  • *****
  • Posts: 1258
    • View Profile
Re: Androxal ETA?
« Reply #2 on: September 03, 2015, 01:11:22 pm »

Looks like November at the latest:

"The company anticipates an FDA approval decision by November 30, 2015 for Androxal, a potential treatment for secondary hypogonadism. The FDA is also planning to hold an advisory committee (ADCOM) meeting to discuss the approvability of Androxal, on November 3, 2015."

http://www.investopedia.com/stock-analysis/060915/repros-therapeutics-inc-poised-move-higher-rprx

PeakT

  • Administrator
  • Hero Member
  • *****
  • Posts: 38446
    • View Profile
    • Peak Testosterone
Re: Androxal ETA?
« Reply #3 on: September 03, 2015, 02:44:19 pm »

Looks like November at the latest:

"The company anticipates an FDA approval decision by November 30, 2015 for Androxal, a potential treatment for secondary hypogonadism. The FDA is also planning to hold an advisory committee (ADCOM) meeting to discuss the approvability of Androxal, on November 3, 2015."

http://www.investopedia.com/stock-analysis/060915/repros-therapeutics-inc-poised-move-higher-rprx

Thanks Osprey.
THE MOST COMPREHENSIVE BOOK ON TRT/TESTOSTERONE:
https://www.amazon.com/Natural-Versus-Testosterone-Therapy-Myer/dp/1523210532/ref=sr_1_1?ie=UTF8&qid=1499116128&sr=8-1&keywords=natural+versus+testosterone+therapy
And check out my New Peak Testosterone Program: http://www.peaktestosterone.com/peak_testosterone_program
If you are on medications or have a medical condition, always check with your doctor first before making any lifestyle changes or taking new supplements.  And low testosterone is a medical condition.

Peak Testosterone Forum

Re: Androxal ETA?
« Reply #3 on: September 03, 2015, 02:44:19 pm »


Nocturne

  • Hero Member
  • *****
  • Posts: 1185
    • View Profile
Re: Androxal ETA?
« Reply #4 on: September 03, 2015, 06:20:04 pm »
Is there any evidence that this drug is superior to Clomid, or is it just common sense?  I've read trials comparing it to gel patches but not Clomid.  Is it more or less effective?  Do we KNOW that it causes fewer side effects?

I would consider sticking with Clomid for a few more months to switch over to Androxal if it comes to that, though I know my doc will likely try to start weaning me off Clomid next month if all goes well.  Since I've been feeling better recently with no med changes in the last month...
43 years old
5'7", was 220 pounds when trouble started, now down to 165
Trouble began with abrupt ED Early May '15
Initial T level 130
Started Clomid in hopes of rebooting system June '15
Currently taking 25 mg eod and .25 mg Arimidex every 4 days
T level 480 or so at last reading
ED in check with 2.5 mg Cialis eod and supplements:
POM juice, L-Cit, Pycnogenol

Morning anxiety currently in check with GABA taken every night

Biggest current worry is heart health:
Aortic stenosis (very mild for now)
CAC score 156(!) at age 42
Lp(a) is a shockingly bad 390 nmol/L -- TRIPLE the "extremely high risk" level!
Homozygous for the bad "G" variant of SNP rs10455872, which increases Lp(a) as well as odds for aortic stenosis and coronary artery lesions. 
I think I know what trashed my heart...

40 mg Crestor and baby aspirin every day
CoQ-10, Vitamin K2, and Kyolic Aged Garlic Extract every day too
Walking 10,000 steps a day

PeakT

  • Administrator
  • Hero Member
  • *****
  • Posts: 38446
    • View Profile
    • Peak Testosterone
Re: Androxal ETA?
« Reply #5 on: September 03, 2015, 06:56:25 pm »
Is there any evidence that this drug is superior to Clomid, or is it just common sense?  I've read trials comparing it to gel patches but not Clomid.  Is it more or less effective?  Do we KNOW that it causes fewer side effects?

I would consider sticking with Clomid for a few more months to switch over to Androxal if it comes to that, though I know my doc will likely try to start weaning me off Clomid next month if all goes well.  Since I've been feeling better recently with no med changes in the last month...

I have not seen user experience anecdotes out there.  Let me know if you find any.
THE MOST COMPREHENSIVE BOOK ON TRT/TESTOSTERONE:
https://www.amazon.com/Natural-Versus-Testosterone-Therapy-Myer/dp/1523210532/ref=sr_1_1?ie=UTF8&qid=1499116128&sr=8-1&keywords=natural+versus+testosterone+therapy
And check out my New Peak Testosterone Program: http://www.peaktestosterone.com/peak_testosterone_program
If you are on medications or have a medical condition, always check with your doctor first before making any lifestyle changes or taking new supplements.  And low testosterone is a medical condition.

electrify

  • Hero Member
  • *****
  • Posts: 1865
    • View Profile
Re: Androxal ETA?
« Reply #6 on: September 13, 2015, 09:49:29 pm »
ugh gotta wait it out for 2 more months :/ but hopefully that will be it and it will be out with no more complications that extend the release date.
Age:24

Osprey

  • Hero Member
  • *****
  • Posts: 1258
    • View Profile
Re: Androxal ETA?
« Reply #7 on: September 14, 2015, 02:36:40 am »
It will be longer than that. If approved in November then they need to start production and get it into distribution. It will probably be several more months before you'll be able to fill a prescription, and it is likely to be extremely expensive.

PeakT

  • Administrator
  • Hero Member
  • *****
  • Posts: 38446
    • View Profile
    • Peak Testosterone
Re: Androxal ETA?
« Reply #8 on: September 14, 2015, 04:50:47 pm »
and it is likely to be extremely expensive.

Why do you say that?  Just based on the price of Cialis and other "men's health" drugs?
THE MOST COMPREHENSIVE BOOK ON TRT/TESTOSTERONE:
https://www.amazon.com/Natural-Versus-Testosterone-Therapy-Myer/dp/1523210532/ref=sr_1_1?ie=UTF8&qid=1499116128&sr=8-1&keywords=natural+versus+testosterone+therapy
And check out my New Peak Testosterone Program: http://www.peaktestosterone.com/peak_testosterone_program
If you are on medications or have a medical condition, always check with your doctor first before making any lifestyle changes or taking new supplements.  And low testosterone is a medical condition.

Osprey

  • Hero Member
  • *****
  • Posts: 1258
    • View Profile
Re: Androxal ETA?
« Reply #9 on: September 14, 2015, 05:27:27 pm »
and it is likely to be extremely expensive.

Why do you say that?  Just based on the price of Cialis and other "men's health" drugs?

Based on my experience with other "new" drugs such as Androgel, Tirosint and Belsomra.

PeakT

  • Administrator
  • Hero Member
  • *****
  • Posts: 38446
    • View Profile
    • Peak Testosterone
Re: Androxal ETA?
« Reply #10 on: September 14, 2015, 05:39:20 pm »


Based on my experience with other "new" drugs such as Androgel, Tirosint and Belsomra.

See my other thread about Lilly doubling the price of a medication (Cialis) that had been out for years. 
THE MOST COMPREHENSIVE BOOK ON TRT/TESTOSTERONE:
https://www.amazon.com/Natural-Versus-Testosterone-Therapy-Myer/dp/1523210532/ref=sr_1_1?ie=UTF8&qid=1499116128&sr=8-1&keywords=natural+versus+testosterone+therapy
And check out my New Peak Testosterone Program: http://www.peaktestosterone.com/peak_testosterone_program
If you are on medications or have a medical condition, always check with your doctor first before making any lifestyle changes or taking new supplements.  And low testosterone is a medical condition.

ThyroidPatient

  • Newbie
  • *
  • Posts: 5
    • View Profile
Re: Androxal ETA?
« Reply #11 on: September 18, 2015, 06:16:22 pm »
It may be expensive at first, but if it works for me it would replace 3 drugs:  cypionate, hCG & anastrazole.  That's approx $200/mo.  That should offset the cost somewhat.

PeakT

  • Administrator
  • Hero Member
  • *****
  • Posts: 38446
    • View Profile
    • Peak Testosterone
Re: Androxal ETA?
« Reply #12 on: September 19, 2015, 03:25:11 am »
It may be expensive at first, but if it works for me it would replace 3 drugs:  cypionate, hCG & anastrazole.  That's approx $200/mo.  That should offset the cost somewhat.

Interesting point.
THE MOST COMPREHENSIVE BOOK ON TRT/TESTOSTERONE:
https://www.amazon.com/Natural-Versus-Testosterone-Therapy-Myer/dp/1523210532/ref=sr_1_1?ie=UTF8&qid=1499116128&sr=8-1&keywords=natural+versus+testosterone+therapy
And check out my New Peak Testosterone Program: http://www.peaktestosterone.com/peak_testosterone_program
If you are on medications or have a medical condition, always check with your doctor first before making any lifestyle changes or taking new supplements.  And low testosterone is a medical condition.

DdR

  • Jr. Member
  • **
  • Posts: 71
    • View Profile
Re: Androxal ETA?
« Reply #13 on: November 05, 2015, 03:10:51 pm »
FDA's advisory committee refused to meet with Androxal's company saying that the data they presented from their studies were inadequate.  It appears that they may have to redo Phase III trials with a much larger pool of participants and focusing on clinical benefits (not just that T levels went up). Long-term safety profile may also be asked for. This will push back approval several years while shooting up the costs.  My bet is that the company will axe its CEO and most of the management board, because they foolhardily tried to get an approval based on a small study. Long-term the company will likely fold and the patent will be sold by creditors. 

I'm not really seeing the big benefit of androxal over the other SERMs, e.g., clomid, nolvadex, etc.  This was a pure profit move since Androxal would have a patent, and Repros could charge a lot more money than generic clomid.

If someone is looking to take exogenous T in a pill form, then Lipocine appears to be your best bet.  Chances are good that it will be approved by the FDA.
Age=35; Weight = 175lbs; Height=5'11"

Lab results 10/13/2013: Total test = 357 ng/dL; Free test = 68.0 pg/mL; SHBG = 31 nmol/L; TSH = 3.19 uIU/mL; Vitamin D = 29 ng/mL

Lab results 4/21/2014: Total test = 465 ng/dL; Free test = 40.45 pg/mL; SHBG = 39.8 nmol/L;
TSH = 3.57 uIU/mL; Vitamin D = Not pulled

Lab results 8/3/2014: Total test = 439 ng/dL; Free test = 21.8 pg/mL; SHBG = Not pulled; TSH = 3.79 uIU/mL; Vitamin D = 23 ng/mL

PeakT

  • Administrator
  • Hero Member
  • *****
  • Posts: 38446
    • View Profile
    • Peak Testosterone
Re: Androxal ETA?
« Reply #14 on: November 05, 2015, 04:49:33 pm »
FDA's advisory committee refused to meet with Androxal's company saying that the data they presented from their studies were inadequate.  It appears that they may have to redo Phase III trials with a much larger pool of participants and focusing on clinical benefits (not just that T levels went up). Long-term safety profile may also be asked for. This will push back approval several years while shooting up the costs.  My bet is that the company will axe its CEO and most of the management board, because they foolhardily tried to get an approval based on a small study. Long-term the company will likely fold and the patent will be sold by creditors. 

I'm not really seeing the big benefit of androxal over the other SERMs, e.g., clomid, nolvadex, etc.  This was a pure profit move since Androxal would have a patent, and Repros could charge a lot more money than generic clomid.

If someone is looking to take exogenous T in a pill form, then Lipocine appears to be your best bet.  Chances are good that it will be approved by the FDA.

They should get their money back on this one, assuming that all is really well, so I guess it's how much capital can they raise, eh?
THE MOST COMPREHENSIVE BOOK ON TRT/TESTOSTERONE:
https://www.amazon.com/Natural-Versus-Testosterone-Therapy-Myer/dp/1523210532/ref=sr_1_1?ie=UTF8&qid=1499116128&sr=8-1&keywords=natural+versus+testosterone+therapy
And check out my New Peak Testosterone Program: http://www.peaktestosterone.com/peak_testosterone_program
If you are on medications or have a medical condition, always check with your doctor first before making any lifestyle changes or taking new supplements.  And low testosterone is a medical condition.

Peak Testosterone Forum

Re: Androxal ETA?
« Reply #14 on: November 05, 2015, 04:49:33 pm »