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Author Topic: When Will Androxal Be Available?  (Read 7383 times)

PeakT

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When Will Androxal Be Available?
« on: August 14, 2015, 05:13:10 pm »
Here is my best guess:

http://www.peaktestosterone.com/Androxal_When_FDA_Approval

(For those who don't know, Androxal is the new "Clomid" with just enclomphine, which should produce much better results for the guys who respond well to Clomid.)
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

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Re: When Will Androxal Be Available?
« Reply #1 on: August 14, 2015, 05:25:06 pm »
Doubt it but if it does come out next month according to your optimistic prediction that would be amazing for me.
Age:24

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Re: When Will Androxal Be Available?
« Reply #1 on: August 14, 2015, 05:25:06 pm »


PeakT

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Re: When Will Androxal Be Available?
« Reply #2 on: August 14, 2015, 05:28:27 pm »
Doubt it but if it does come out next month according to your optimistic prediction that would be amazing for me.

Me too.  But my crystal ball is a little dusty...
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.

Nocturne

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Re: When Will Androxal Be Available?
« Reply #3 on: August 14, 2015, 06:02:20 pm »
Doubt it but if it does come out next month according to your optimistic prediction that would be amazing for me.

Me too.  There has to be something to the fact that both when I first went on Clomid and again when I doubled my original dose, I felt great and had almost complete remission of ED for about a week before losing those gains.  Was the loss due to zuclomiphine?  Would be worth finding out.
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

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Re: When Will Androxal Be Available?
« Reply #3 on: August 14, 2015, 06:02:20 pm »


OS

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Re: When Will Androxal Be Available?
« Reply #4 on: August 14, 2015, 06:11:52 pm »
Is it anticipated that Androxal might be used in conjunction with topical/injected testosterone, as a way to combat testicular shrinkage, or any other reason?   Would it be effective for that?  Or will Androxal be a stand-alone therapy?

PeakT

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Re: When Will Androxal Be Available?
« Reply #5 on: August 14, 2015, 06:18:10 pm »
Is it anticipated that Androxal might be used in conjunction with topical/injected testosterone, as a way to combat testicular shrinkage, or any other reason?   Would it be effective for that?  Or will Androxal be a stand-alone therapy?

I don't think so.  For example, no one really uses Clomid with TRT.  The goals of the two imo are directly opposing each other. 
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

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Re: When Will Androxal Be Available?
« Reply #6 on: August 14, 2015, 11:56:13 pm »
Hopefully androxal isn't like Nolvadex either where blocking E2 negates the effects of the increased T. I literally feel nothing on Nolvadex and maybe even somewhat worse on it than before starting.

At least Androxal has a shorter half life so the molecule won't just sit there in the brain for long periods blocking E2 recptors in the brain. On the other hand Nolvadex would tend to accumulate in the brain with each dose.
Age:24

PeakT

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Re: When Will Androxal Be Available?
« Reply #7 on: August 15, 2015, 05:43:25 am »
Hopefully androxal isn't like Nolvadex either where blocking E2 negates the effects of the increased T. I literally feel nothing on Nolvadex and maybe even somewhat worse on it than before starting.

At least Androxal has a shorter half life so the molecule won't just sit there in the brain for long periods blocking E2 recptors in the brain. On the other hand Nolvadex would tend to accumulate in the brain with each dose.

Yeah, I'm super curious about a lot of things with Androxal.  I'm wondering if some guys will feel a lot better on it since it's keeping the pituitary and hypothalamus in the loop.  And I'm wondering, though, if it will really boost testosterone that much as you may know from one of my pages.
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.

Nocturne

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Re: When Will Androxal Be Available?
« Reply #8 on: August 15, 2015, 01:38:42 pm »
I could swear I recently saw a study that showed enclomiphene (Androxal) raising T more than Clomid did in monkeys.  IIRC it performed better than a gel too.  I'll look for it.

Also, if you've been on Clomid, an important factor might be FEELING better due to the removal of zuclomiphene from the equation.  If I could feel as good on Androxal long-term as I felt for my first week or so on Clomid (and again after doubling my dose), I'd have my preferred treatment right there with no reason to look anywhere else.  Of course that hinges on the loss of effectivity after the first week or so being due to the effects of zuclomiphene somehow...  But I'd be pushing my doc to switch me over right now if Androxal were available.
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

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Re: When Will Androxal Be Available?
« Reply #9 on: August 15, 2015, 03:11:08 pm »
I could swear I recently saw a study that showed enclomiphene (Androxal) raising T more than Clomid did in monkeys.  IIRC it performed better than a gel too.  I'll look for it.

Also, if you've been on Clomid, an important factor might be FEELING better due to the removal of zuclomiphene from the equation.  If I could feel as good on Androxal long-term as I felt for my first week or so on Clomid (and again after doubling my dose), I'd have my preferred treatment right there with no reason to look anywhere else.  Of course that hinges on the loss of effectivity after the first week or so being due to the effects of zuclomiphene somehow...  But I'd be pushing my doc to switch me over right now if Androxal were available.

Sure.  A lot of guys feel that way.  Let me know if you run across that study.
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.

xrayguy

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Re: When Will Androxal Be Available?
« Reply #10 on: August 15, 2015, 03:29:26 pm »
Interesting that Androxal is actually being marketed as a treatment for male hypogonadism. This would be good news for us in Canada because other drugs are for use in women only and are considered "off label" for men, and therefore are not used here.

I just found this info FYI:

THE WOODLANDS, Texas, June 8, 2015 (GLOBE NEWSWIRE) -- Repros Therapeutics Inc.(Nasdaq:RPRX) today announced that the Division of Bone, Reproductive and Urologic Products of the U.S. Food and Drug Administration (FDA) has scheduled the advisory committee to review the Company's New Drug Application (NDA) for its enclomiphene product candidate, formerly known as Androxal, on November 3, 2015. The Company submitted the NDA on January 30, 2015. The FDA accepted the NDA for review on April 1, 2015 and later assigned a Prescription Drug User Fee Act (PDUFA) goal date of November 30, 2015.
Age 48, 5'10" 185lbs, from Canada

Symptoms: Anxiety, abdominal bloating/cramps/tenderness, fatigue, weakness, insomnia.

Rx treatment:
10/21/2015: NOTHING
10/15/2015: 120mg Testosterone cream
9/11/2015: 100mg Testosterone cream, 10/5/2.5mg Cortef
8/1/2015: 100mg Testosterone cream
7/23/2015: 100mg Testosterone cream, 15mg Thyroid
6/30/2015: 100mg Testosterone Cypionate/week, 0.5mg Arimidex 2x/week

Recent Tests March 2016:
T 234 ng/dl (297-850)
E2 19 pg/ml (<54)
SHBG 0.23 (0.20-1.00)
DHEAS 11.8 umol/L (<14.0)
TSH 4.63 mU/L (0.2-4.0)
Free T3: 6.2 pmol/L (3.5-6.5)
Free T4: 16.2 pmol/L (9.0-23.0)
Cortisol AM 279 nmol/L (120-620)
Cortisol PM 166 nmol/L (85-460)

Previous Tests:
T (300-1100ng/dl): 579>507>182>300>369>234
E2 (<54pg/ml): 72>59>43>28>25>19

Nocturne

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Re: When Will Androxal Be Available?
« Reply #11 on: August 15, 2015, 06:25:03 pm »
How long after the PDUFA date would we be able to expect it to become available at local pharmacies?
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

electrify

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Re: When Will Androxal Be Available?
« Reply #12 on: August 15, 2015, 07:52:39 pm »
I'm sure it will raise T quite a bit provided you are young....
Age:24

PeakT

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Re: When Will Androxal Be Available?
« Reply #13 on: August 15, 2015, 11:14:16 pm »
How long after the PDUFA date would we be able to expect it to become available at local pharmacies?

I believe it will go to market pretty rapidly - within a few months - but it could be under post-market surveillance.  I'm not sure how much that affects availability.  I've got a relative I can ask.  Will ask about that and let you know what he says...
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.

DKC24

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Re: When Will Androxal Be Available?
« Reply #14 on: August 16, 2015, 03:37:48 am »
what is the difference between this and clomid? less side effects?

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Re: When Will Androxal Be Available?
« Reply #14 on: August 16, 2015, 03:37:48 am »