Dutasteride Finally Goes into Phase III Trials **UPDATED**

[JohnnySeville]

Now is your time to sign up! Free dutasteride!
Looks like all those phone calls by JayMan to GSK have finally paid off!



A Study To Assess The Efficacy And Safety Of Dutasteride 0.5mg Once Daily For 6 Months In The Treatment Of Male Subjects With Androgenetic Alopecia

This study is currently recruiting patients.
Verified by GlaxoSmithKline February 2007

Sponsored by: GlaxoSmithKline
Information provided by: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00441116

Purpose
The aim of this Phase III study is to compare the efficacy, safety and tolerability of dutasteride (0.5mg) with placebo for 6 months, in Korean male subjects with androgenetic alopecia in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification. Condition Intervention Phase
Androgenetic Alopecia
Drug: Dutasteride 0.5mg oral tablets
Phase III

MedlinePlus related topics: Hair Diseases and Hair Loss
Genetics Home Reference related topics: Hair Diseases and Hair Loss
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: An Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of Dutasteride 0.5mg Once Daily for 6 Months in the Treatment of Male Subjects With Androgenetic Alopecia (Norwood-Hamilton Classification Type IIIv, IV and V)
Further study details as provided by GlaxoSmithKlinerimary Outcomes: Hair growth assessed by macrophotographic technique (hair count) in the vertex at 6 months.
Secondary Outcomes: Subject assessment of change in hair growth and loss. Panel and investigator photographic assessment of change in hair growth Hormone measurements of LH at screening and DHT, testosterone, TSH, and T4. Assessment of sexual function
Expected Total Enrollment: 150 Study start: December 2006

Eligibility
Ages Eligible for Study: 18 Years - 49 Years, Genders Eligible for Study: Male CriteriaInclusion criteria:

Diagnosis of Male Pattern Hair Loss classified as type IIIv, IV, or V utilising the modified Norwood-Hamilton classification (N.B. types IVa and Va are excluded)
Exclusion criteria:

Global scalp hair thinning, including occipital areas
Scarring of the scalp or any other condition or disease of the scalp or hair, including diseases of the hair shaft and inability to discontinue use of hair weaving.
Subjects who use hair colourants/hair dyes, or have the remaining traces of colourants in their hair.
Use of finasteride or other 5 AR inhibitors within the 12 months prior to screening.
Previous use of dutasteride.
Use of phytotherapy (e.g. saw palmetto) within 8 weeks prior to screening.
Use of the following during the 6 months prior to screening:

Minoxidil (oral or topical)
Drugs with anti-androgenic properties (e.g., cyproterone acetate, spironolactone, ketoconazole, flutamide, bicalutamide). Cimetidine cannot be used during the study but is not an excluded drug when used during the previous 6 months.
Topical estrogen, progesterone
Tamoxifen
Drugs potentially causing hypertrichosis (e.g., cyclosporine, diazoxide, phenytoin psoralens)
Anabolic steroids
Lithium and phenothiazines
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00441116

Korea, Republic of
GSK Clinical Trials Call Center, Seoul, 110-744, Korea, Republic of; Recruiting
GSK Clinical Trials Call Center 1-877-379-3718 oskwon@snu.ac.kr


GSK Clinical Trials Call Center, Seoul, 140-702, Korea, Republic of; Not yet recruiting
GSK Clinical Trials Call Center 1-877-379-3718 drro@netsgo.com


GSK Clinical Trials Call Center, Seoul, 134-090, Korea, Republic of; Recruiting
GSK Clinical Trials Call Center 1-877-379-3718 sim@khnmc.or.kr


GSK Clinical Trials Call Center, Wonju, 220-701, Korea, Republic of; Recruiting
GSK Clinical Trials Call Center 1-877-379-3718 leews@wonju.yonsei.ac.kr

Study chairs or principal investigators
GSK Clinical Trials, M.D., Ph.D., Study Director, GlaxoSmithKline More Information
Study ID Numbers: 106377
Last Updated: February 27, 2007
Record first received: February 27, 2007
ClinicalTrials.gov Identifier: NCT00441116
Health Authority: Korea: Food and Drug Administration

 

[roki]

wow that's great!
i cant wait for the results ,lets hope its approved
anybody wanna bet? ill put 200$ that its approved
common you pussies ,place your bets

 

[beaner]

Why are the clinical trials going to be held in Korea? Anyone have an idea?

 

[H2O]

Why are the clinical trials going to be held in Korea? Anyone have an idea?

Dollars and Cents no doubt. They save money where they can and it's probably cheaper to utilize physicians and labs in Korea....that's my guess anyway.

 

[Sean68]

good stuff. feel less like a lab rat now!

 

[beaner]

Why are the clinical trials going to be held in Korea? Anyone have an idea?

Dollars and Cents no doubt. They save money where they can and it's probably cheaper to utilize physicians and labs in Korea....that's my guess anyway.

Sounds like a good guess to me. You're probably right.

 

[JohnnySeville]

wow that's great!
i cant wait for the results ,lets hope its approved
anybody wanna bet? ill put 200$ that its approved
common you pussies ,place your bets

I am sure it's a done deal, just a formality since all the work has already been done. We all know it works and will not kill you immediately, only unknown is long term, and this trial will not even stratch the surface on that aspect.

 

[JohnnySeville]

good stuff. feel less like a lab rat now!

As far as its long term effects, you still are. Say Cheese!

 

[Bryan]

I find a couple of issues quite interesting:

1) Judging from that short blurb, all they're apparently testing is just the standard dutasteride dose of 0.5 mg/day. I suspect that Glaxo isn't too keen on the idea of people using larger doses than that.

2) Why on earth are they "re-inventing the wheel"?? Why are they simply duplicating (for the most part) a trial that they already performed a few years ago??

Bryan

 

[H2O]

I find a couple of issues quite interesting:

1) Judging from that short blurb, all they're apparently testing is just the standard dutasteride dose of 0.5 mg/day. I suspect that Glaxo isn't too keen on the idea of people using larger doses than that.

2) Why on earth are they "re-inventing the wheel"?? Why are they simply duplicating (for the most part) a trial that they already performed a few years ago??

Bryan

For both questions....possibly to "go with what they know". I would assume they are just trying to get the Phase III status complete as cheaply and "cleanly" as possible to legally open up a "new" market for their drug. They already have some longer term followup statistics on the .5mg/day dosage through their FDA approval to treat BHP. If they stick with that dosage, no "surprises" will pop up as far as safety and health issues and they can probably use data from the other studies to back up those safety concerns for FDA approval.

What I find interesting is that usually Phase III trials involve at least 1000 participants if not 2 or 3 times that number. I must be reading something wrong...it looked like only a few hundred participants were going to be utilized in this study.

Expected Total Enrollment: 150 Study start: December 2006

What gives with that...?

Also as far as "reinventing the wheel"...I would take a certain comfort in them finding superior performance in the .5 mg/day dosage yet again in a controlled FDA study, as this is the dosage we all have settled upon to take in order to balance results with sides....

Bryan...what would you like to be included in the Phase III trials beyond the scope outlined above. What would you change and/or include/examine in the next study if you could "have your druthers", so to speak...?

 

[Bryan]

For both questions....possibly to "go with what they know". I would assume they are just trying to get the Phase III status complete as cheaply and "cleanly" as possible to legally open up a "new" market for their drug.

But it's NOT a "phase III" trial, as you yourself point out below. It's of smaller scope than the first one they did a few years ago.

What I find interesting is that usually Phase III trials involve at least 1000 participants if not 2 or 3 times that number. I must be reading something wrong...it looked like only a few hundred participants were going to be utilized in this study.

Expected Total Enrollment: 150 Study start: December 2006

What gives with that...?

Right. It's not a "phase III" study. BTW, the earlier trial a few years ago used 416 test subjects.

Bryan...what would you like to be included in the Phase III trials beyond the scope outlined above. What would you change and/or include/examine in the next study if you could "have your druthers", so to speak...?

A proper phase III trial should last for a couple years, like the Propecia trial.

Bryan

 

[H2O]

A proper phase III trial should last for a couple years, like the Propecia trial.

Bryan

So what do you think this is all about then? Is it even "legal" or "possible" to get a "Phase III" stamp of approval from the FDA if they complete the study as outlined above? Does the FDA mandate a minimum # of participants or length of time inorder to meet certain criteria ? I'm going to check the manufacture's newswire and get back in a second...see if there's any mention on their home site...

 

[H2O]

So here is the link to GSK's list of current trials...take a peek...

http://ctr.gsk.co.uk/Summary/dutasteride/studylist.asp

I'm sifting through it as we speak...

 

[Bryan]

I can't figure out what the point of it is. It's just a duplication (and a SMALLER one, at that) of what they did years ago.

Bryan

 

[H2O]

...and nothing has been mentioned on their newswire or listed in their "trials" page. I find it strange the manufacturer GSK would not have any mention on their website. Somthing does not smell right in the kitchen...

 

[H2O]

For what it's worth...I did find this on Avodart as far as long term (4 year) effects...this quote was taken from a news release...

A total of 2,802 men were randomized into the double-blind phase of the two
studies; 1,908 completed the two year double-blind portion. In the open-label
phase, 1,570 subjects were enrolled, 778 of whom previously received placebo,
and 792 who previously received Avodart. Overall, 569 subjects received Avodart
for 4 years.1
"The improvements compared to baseline demonstrate the ability of Avodart to
help ease the symptoms of BPH, which can help improve the quality of life for the
patient," commented Dr. Roehrborn.
Additionally, long-term treatment resulted in a low incidence of drug-related side
effects. The incidence of drug-related side effects decreased with duration of
treatment. In year four, the most frequently observed drug-related side effects for
men treated with Avodart for four years were: gynecomastia (breast enlargement
and breast tenderness) (1%); impotence (0.4%); ejaculation disorders (0.1%).

So over a 4 year study the incidence of sides seemed to keep in line with original estimates...more or less.

Still, as Bryan said, the above so called"phase III" trials seems to have very little obvious purpose or benefit....cannot figure it out at all...oh well on to bigger and better things I guess...

 

[roki]

maybe someone could e-mail them

 

[Lorenzo_91]

i would never volunteer. What if I got the freaking placebo. Oh no hell no.

 

[AussieExperiment]

Could be just a publicity stunt

This could just be a publicity stunt. GSK knows that many people are using dutasteride for hairloss even without FDA approval. Perhaps this is just a way of trying to encourage more people to use the drug and make them feel more at ease without actually gaining FDA approval.

 

[Jojje]

yea lorenzo.. haha it would suck to already be on dutasteride... then go with the trials and get placebo for 6 months haha.
Then lose all the ground you have built up