Dutasteride as a Hair Loss Treatment?
AVODART™ IS INTENDED FOR THE TREATMENT OF BENIGN PROSTATE ENLARGEMENT. PLEASE CHECK WITH YOUR DOCTOR IF HE WILL PRESCRIBE AVODART™ AS A HAIR LOSS TREATMENT FOR YOU.
Below are mainly information we compiled based on discussions in our forum community. Please do not consider information presented herein or anywhere on HairSite as medical advice. We are not able to verify the accuracy of the information we obtained from forum members. As always, please consult your doctor before proceeding with any treatment for hair loss and do not start a regimen unless you are doing so under the supervision of your doctor. There is no one treatment that works for all types of hair loss and some treatments are experimental in nature and may produce undesirable or even life threatening side effects.
FDA clearance for Avodart or dutasteride was granted to GlaxoSmithKline on October 9, 2002. This is the biggest news in hair loss treatment since Propecia. If you want the latest discussions, debates and developments about Avodart or Dutasteride, visit the hair loss forum. But if you just want to read about forum summaries and important issues about Avodart or Dutasteride on an ongoing basis, this page will be very helpful. Most information here are courtesy of posters in the Dutasteride Forum.
TABLE OF CONTENTS
After 30 Dutasteride forums in HairSite and endless speculation for almost two years, Dutasteride is finally a reality under the brand name Avodart™ !
The FDA approval for NDA#21-319/s-001 was given on October 9, 2002 and the label was posted on the same day.
This is the biggest news in hair loss treatment since FDA's clearance for Propecia in December 1997. The interesting thing is that Avodart is NOT a hair loss drug !!
Avodart™ (Dutasteride) is approved for the treatment of Benign Prostatic Hyperplasia (BPH). Not to be mistakened with prostate cancer, BPH is a non-cancerous enlargement of the prostate glands. It is fairly common among older men aged 50 or above. BPH usually manifest in a variety of lower urinary tract symptoms (LUTS) such as urinary frequency, urgency, nighttime urination, decrease in urinary stream, incomplete emptying and incontinence etc.
Avodart is a synthetic 4-azasteroid compound. It is the first FDA approved medication that can inhibit both types of 5-alpha reductase (5AR), an enzyme that is commonly believed to responsible for the conversion of testosterone to 5 alpha-dihydrotestosterone (DHT). It is widely suggested that DHT is the main androgen responsible for prostate growth as well as male pattern baldness.
Avodart standard dosage is 0.5mg of the active ingredient dutasteride per soft gelatin capsule. The capsule is compounded by dissolving 0.5mg of dutaseride in a combination of mono-di-glycerides caprylic/capric acid and butylated hydroxytoluene. Other ingredients include BSE-free bovine gelatin, glycerin and yellow ferric oxide.
If you are able to obtain Dutasteride in its raw form, you might even be able to compound your own Dutasteride topical solution. It was reported in Avodart's prescribing information that the medication is absorbed through the skin as well. Dutasteride in its raw form is a white-yellowish powder. It is insoluble in water but can easily be dissolved in ethanol (44mg/mL), methanol (64 mg/mL) and polyethylene glycol 400 (3mg/mL). However, please note that effectiveness of Dutasteride or Avodart as a hair loss treatment has not been clinically established.
You may want to follow this for a more thorough discussion about topical dutasteride:
>>That would be great because of the absence of side effects, but I have always wondered about the efficacy of topical alpha-5 reductase inhibitors. Granted there is evidence that DHT is manufactured in the scalp and hair follicle, and this no doubt contibutes to the damage, but what about DHT manufactured elsewhere and carried to the hair via the bloodstream?<<
In my opinion, serum DHT *does* have an effect on hair follicles, but it's a relatively minor one compared to the effect of the DHT that's manufactured right there inside the follicles.
Why do I believe that? Mainly because of some very convincing animal evidence: topical 5a-reductase inhibitors have a VERY potent effect in standard animal models like the hamster flank-organ and ear pinna. Indeed, those topical substances that have no systemic effect whatsoever are able to produce nearly castration-like effects in the animals' sebaceous glands (hair follicles, too, apparently) where they're applied. So what happens when you try to make your very same argument about the animals?? The animals' sebaceous glands are exquisitely sensitive to the effects of androgens (and DHT in particular), too, and yet they shrink right up when you apply topical 5a-reductase inhibitors to them! That proves that locally-produced DHT is more important than serum DHT, at the very least in those animals; and there's no particular reason not to think that the same is true in humans. In fact, I can cite a *human* study where the researchers concluded that sebaceous glands are not responsive to serum DHT.
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Unlike Finasterdie (Propecia or Proscar) which only inhibits Type II 5AR, Dutasteride functions as a dual 5AR inhibitors and have been proven to be more effective as an treatment for BPH and possibly pattern hair loss or baldness. According to GSK, Dutasteride has shown to exhibit significantly less inter-individual variation in the level of DHT suppression compared to Finasteride.
A comparison between Avodart (Dutasteride) and Proscar (Finasteride 5 mg) can be found in Dutasteride forum. Email firstname.lastname@example.org to obtain the archive contents, quote link address http://www.hairsite7.com/m603dutas29/_disc603/00000172.htm
Scientists have evaluated the effectiveness of Dutasteride at different daily dosage, ranging from 0.01 mg, 0.05 mg, 0.5 mg, 2.5 mg, and 5.0 mg per day. It was found that the highest suppression of DHT was achieved with 2.5 mg or 5.0 mg per day. At a daily dosage of 2.5 mg or 5.0 mg, Dutasteride suppresses close to 100% of the DHT whereas 5.0 mg daily dosage of Finasteride only suppresses close to 70% of the DHT. According to information provided by GSK, the level of DHT suppression does not seem to different significantly between 2.5 mg and 5.0 mg. And at a daily dose of 0.5mg, DHT inhibiton is close to 90%. Please also read below OPTIMAL DOSE FOR HAIR LOSS.
According to Avodart or dutasteride's prescribing information, the maximum effect of dutasteride can be observed within 1 to 2 weeks. "After 1 and 2 weeks of daily dosing with dutasteride 0.5mg, median serum DHT concentrations were reduced by 85% and 90% respectively." It was further reported that test patients treated with a daily dosage of 0.5mg dutasteride for 2 years, the median decrease in serum DHT concentration was over 92% for both year 1 and year 2 of the 2-year trial.
1) Women or children should not use Avodart™ or dutasteride.
2) Women who are pregnant or may be pregnant should not handle Avodart™ for fear of potential risks to a male fetus.
3) No measurable bone mineral density level change was observed in test patients after a 52 weeks trial.
4) Men using Avodart™ or dutasteride should not donate blood until at least 6 months after the medication was last used for fear of possible administration of dutasteride tainted blood to pregnant female transfusion patient.
5) Men with liver problems should not use Avodart™.
6) Patients' ejaculate volume might decrease as a result of the medication. A small number of the test patients experienced impotence and a reduction in libido.
7) No clinically significant change in hormone levels were observed in test patients.
8) No clinically significant changes in sperm concentration, sperm motility or sperm morphology although some subjects reported reduction in ejaculate volume.
9) A 2-year statistical summary showed that sexual adverse events such as impotence, decreased libido, and ejaculation disorder decreased with the duration of the treatment. Fewer incidences of adverse sexual events were reported over time.
For the treatment of BPH, the official recommendation from GSK is to take 1 x 0.5mg capsule orally every day with or without food.
However, it appears that for treating hair loss, a daily dose of 2.5mg daily seems to generate the best results.
Also, please note the effect of Avodart on serum DHT vs scalp DHT.
0.5mg Dutasteride inhibits ~ 92% serum DHT and 55% scalp DHT
2.5mg Dutasteride inhibits ~ 95% serum DHT and 82% scalp DHT
DarkMage and Bryan in the Dutasteride forum have also provided very valuable information about the optimal daily dose for dutasteride. You can find their charts and analysis at Dutasteride "Optimal Daily Dose" (archived link address http://www.hairsite4.com/dc/dcboard.php?az=show_topic&forum=11&topic_id=24658&mode=full). Also, another dutasteride dose discussion and charts put together by Boris (archived link address http://www.hairsite.com/hair-loss/board_entry-id-20130-page-3-category-5-order-last_answer-descasc-DESC.html).
Please read Bryan's interpretation about whether Avodart should be taken with or without food:
Re: Bryan or anyone, what does this mean, in plain simple English...
Time: 5:58:44 PM
Remote Name: 184.108.40.206
"Following administration of a single 0.5 mg dose of a soft gelatin capsule, time to peak serum concentrations of dutasteride occurs within 2 to 3 hours. Absolute bioavailability in five healthy subjects is approximately 60% (range 40% to 94%). When the drug is administered with food, the maximum serum concentrations were reduced by 10% to 15%. This reduction is of no clinical significance."
>>What are they saying here ??? Does it mean that if we take dutasteride with food, the medication will remain in our body longer? Even though they say there is no clinical significance, would it be better to have the medication in our body 10-15% longer ?<<
No, I think they're clearly saying that less of the drug is absorbed (or "bioavailable") when taken along with food. For just a second or two I also wondered (as you seemed to do) if they meant that the absorption of the drug is merely SLOWED DOWN for a while but still eventually gets absorbed; however, the fact that it has such a long half-life and yet the peak levels in the blood are still reduced strongly suggests to me that there's that extra percentage of it that never does get absorbed, when it's taken with food.
Please note that the Avodart™ we have seen are oblong, opaque, dull yellow, gelatin capsules with the word "GX CE2" clearly printed in red on one side. Avodart™ is packaged in bottles of 100 (NDC 0173-0712-00) with child resistant closures. You may also find other Avodart™ in blister packs of 70 capsules (NDC 0173-0712-01). It seems that the pill may come in different packaging depending on the country of origin, we are unable to establish any proof or what to look for in order to identify fake Avodart pills. Buyers beware.
15-30 degrees Celsius or 59 - 86 degrees F.
Discussions here about half-life are mostly courtesy of Bryan in Dutasteride Forum.
Half-life refers to the time (usually in hours) required for one-half the dose of a drug to be excreted from the body. The following half-life information about Avodart™ or dutasteride is found in the prescribing information:
"The terminal half-life of dutasteride is approximately 5 weeks at steady state. The average steady-state serum dutasteride concentration was 40 ng/mL following 0.5 mg/day for 1 year. Following daily dosing, dutasteride serum concentrations achieve 65% of steady-state concentration after 1 month and approximately 90% after 3 months. Due to the long half-life of dutasteride, serum concentrations remain detectable (greater than 0.1 ng/mL) for up to 4 to 6 months after discontinuation of treatment. "
Avodart or Dutasteride has relatively much longer half-life than Propecia. However, it does not necessarily mean that you can reap substantial cost savings because in the long run, you have to sustain the same amount of medication in your body in order to see results. You might be able to "defer" the money you spent on Avodart, but not cutting the overall amount you spend. The real significance of long half-life is that it allows for very flexible dosing schemes. You can take a small amount daily or a larger dose less frequently. But the key is to average the same amount. For example, if your goal is to average 0.5mg in your body, then you can take 0.5mg daily or 3.5mg weekly.
Note that while Avodart or Dutasteride has a long half-life, it does not necessarily mean that the medication will simply stay fixed at the highest "peak" level all the time.
New study suggests that dutasteride might be effective for women with hair loss. Journal of Drugs in Dermatology, Sept-Oct, 2005 by Malgorzata Olszewska, Lidia Rudnicka: " After 6 months of therapy, significant improvement was observed and after 9 months the clinical diagnosis of androgenic alopecia could no longer be made in this patient. No side effects were observed. In conclusion, theoretical data and our experience in this case show that dutasteride might develop into a true alternative in treatment of androgenic alopecia."
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