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Online Propecia

January 26th, 2008 by admin

Brand names

Online Propecia

Drug trade names include Propecia and Proscar, both products of Merck & Co. (the former is marketed for hair loss in male pattern baldness, and the latter for BPH). There is 1 mg of finasteride in Propecia and 5 mg in Proscar.

Cipla also manufactures finasteride (trade names Fincar and Finpecia), as does Dr. Reddy’s (trade names Finax and Finast), Ranbaxy (trade name Finara), Intas (trade name Finalo), and Aleppo Pharmaceutical (trade name Prosteride), who sell the drug at a significantly lower cost than Merck.

Use as a treatment for hair loss

In a 5-year study of men with mild to moderate hair loss, 48% of those treated with Propecia (finasteride 1mg) experienced some regrowth of hair, and 42% had no further loss. Average hair count in the treatment group remained above baseline, and showed an increasing difference from hair count in the placebo group, for all five years of the study.[5]. Propecia is effective only for as long as it is taken; the hair gained or maintained is lost within 6-12 months of ceasing therapy.[7] In clinical studies, Propecia, like minoxidil, was shown to work on both the crown area and the hairline,[8] but is most successful in the crown area.

Some users, in an effort to save money, buy Proscar instead of Propecia, and split the Proscar pills to approximate the Propecia dosage. Doing so is generally considered unadvisable if women of pregnancy age are in the household; this is because finasteride, even in small concentrations, can cause birth defects in a developing male fetus. The birth defects involve the development of male genitalia (no such effects have been noted in developing female fetuses). On most product inserts, it will be mentioned that the dust or crumbs from broken Propecia tablets should be kept away from pregnant women.

Propecia has been shown to be ineffective for treating hair loss in women.[citation needed] However, Propecia’s supporters respond that the study was on post-menopausal women whose hair loss was more likely related to the loss of estrogen versus a sensitivity to testosterone. Many doctors prescribe it for women, but not without either careful birth control measures or assurance that the woman cannot become pregnant.

Clinical Studies
Studies in Men
The efficacy of Online Propecia was demonstrated in men (88% Caucasian) with mild to moderate
androgenetic alopecia (male pattern hair loss) between 18 and 41 years of age. In order to prevent
seborrheic dermatitis which might confound the assessment of hair growth in these studies, all men,
whether treated with finasteride or placebo, were instructed to use a specified, medicated, tar-based
shampoo (Neutrogena T/Gel
®
**
Shampoo) during the first 2 years of the studies.
There were three double-blind, randomized, placebo-controlled studies of 12-month duration. The two
primary endpoints were hair count and patient self-assessment; the two secondary endpoints were
investigator assessment and ratings of photographs. In addition, information was collected regarding
sexual function (based on a self-administered questionnaire) and non-scalp body hair growth. The three
studies were conducted in 1879 men with mild to moderate, but not complete, hair loss. Two of the studies
enrolled men with predominantly mild to moderate vertex hair loss (n=1553). The third enrolled men
having mild to moderate hair loss in the anterior mid-scalp area with or without vertex balding (n=326).
Studies in Men with Vertex Baldness
Of the men who completed the first 12 months of the two vertex baldness trials, 1215 elected to
continue in double-blind, placebo-controlled, 12-month extension studies. There were 547 men receiving
PROPECIA for both the initial study and first extension periods (up to 2 years of treatment) and 60 men
PROPECIA? (Finasteride) Tablets, 1 mg
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receiving placebo for the same periods. The extension studies were continued for 3 additional years, with
323 men on PROPECIA and 23 on placebo entering the fifth year of the study.
In order to evaluate the effect of discontinuation of therapy, there were 65 men who received
PROPECIA for the initial 12 months followed by placebo in the first 12-month extension period. Some of
these men continued in additional extension studies and were switched back to treatment with
PROPECIA, with 32 men entering the fifth year of the study. Lastly, there were 543 men who received
placebo for the initial 12 months followed by Online Propecia in the first 12-month extension period. Some of
these men continued in additional extension studies receiving PROPECIA, with 290 men entering the fifth
year of the study (see Figure below).
Hair counts were assessed by photographic enlargements of a representative area of active hair loss.
In these two studies in men with vertex baldness, significant increases in hair count were demonstrated at
6 and 12 months in men treated with Online Propecia, while significant hair loss from baseline was
demonstrated in those treated with placebo. At 12 months there was a 107-hair difference from placebo
(p<0.001, PROPECIA [n=679] vs placebo [n=672]) within a 1-inch diameter circle (5.1 cm
2
). Hair count
was maintained in those men taking PROPECIA for up to 2 years, resulting in a 138-hair difference
between treatment groups (p<0.001, PROPECIA [n=433] vs placebo [n=47]) within the same area. In men
treated with PROPECIA, the maximum improvement in hair count compared to baseline was achieved
during the first 2 years. Although the initial improvement was followed by a slow decline, hair count was
maintained above baseline throughout the 5 years of the studies. Furthermore, because the decline in the
placebo group was more rapid, the difference between treatment groups also continued to increase
throughout the studies, resulting in a 277-hair difference (p<0.001, PROPECIA [n=219] vs placebo [n=15])
at 5 years (see Figure below).
Patients who switched from placebo to PROPECIA (n=425) had a decrease in hair count at the end of
the initial 12-month placebo period, followed by an increase in hair count after 1 year of treatment with
PROPECIA. This increase in hair count was less (56 hairs above original baseline) than the increase (91
hairs above original baseline) observed after 1 year of treatment in men initially randomized to
PROPECIA. Although the increase in hair count, relative to when therapy was initiated, was comparable
between these two groups, a higher absolute hair count was achieved in patients who were started on
treatment with PROPECIA in the initial study. This advantage was maintained through the remaining 3
years of the studies. A change of treatment from PROPECIA to placebo (n=48) at the end of the initial 12
months resulted in reversal of the increase in hair count 12 months later, at 24 months (see Figure below).
At 12 months, 58% of men in the placebo group had further hair loss (defined as any decrease in hair
count from baseline), compared with 14% of men treated with PROPECIA. In men treated for up to 2
years, 72% of men in the placebo group demonstrated hair loss, compared with 17% of men treated with
PROPECIA. At 5 years, 100% of men in the placebo group demonstrated hair loss, compared with 35% of
men treated with PROPECIA.

Online Propecia
Patient self-assessment was obtained at each clinic visit from a self-administered questionnaire, which
included questions on their perception of hair growth, hair loss, and appearance. This self-assessment
demonstrated an increase in amount of hair, a decrease in hair loss, and improvement in appearance in
men treated with PROPECIA. Overall improvement compared with placebo was seen as early as 3
months (p<0.05), with improvement maintained over 5 years.
Investigator assessment was based on a 7-point scale evaluating increases or decreases in scalp hair
at each patient visit. This assessment showed significantly greater increases in hair growth in men treated
with PROPECIA compared with placebo as early as 3 months (p<0.001). At 12 months, the investigators
rated 65% of men treated with PROPECIA as having increased hair growth compared with 37% in the
placebo group. At 2 years, the investigators rated 80% of men treated with PROPECIA as having
increased hair growth compared with 47% of men treated with placebo. At 5 years, the investigators rated
77% of men treated with PROPECIA as having increased hair growth, compared with 15% of men treated
with placebo.
An independent panel rated standardized photographs of the head in a blinded fashion based on
increases or decreases in scalp hair using the same 7-point scale as the investigator assessment. At 12
months, 48% of men treated with PROPECIA had an increase as compared with 7% of men treated with
placebo. At 2 years, an increase in hair growth was demonstrated in 66% of men treated with PROPECIA,
compared with 7% of men treated with placebo. At 5 years, 48% of men treated with PROPECIA
demonstrated an increase in hair growth, 42% were rated as having no change (no further visible
progression of hair loss from baseline) and 10% were rated as having lost hair when compared to
baseline. In comparison, 6% of men treated with placebo demonstrated an increase in hair growth, 19%
were rated as having no change and 75% were rated as having lost hair when compared to baseline.
Other Results in Vertex Baldness Studies
A sexual function questionnaire was self-administered by patients participating in the two vertex
baldness trials to detect more subtle changes in sexual function. At Month 12, statistically significant
differences in favor of placebo were found in 3 of 4 domains (sexual interest, erections, and perception of
sexual problems). However, no significant difference was seen in the question on overall satisfaction with
sex life.

Online Propecia
In one of the two vertex baldness studies, patients were questioned on non-scalp body hair growth.
PROPECIA did not appear to affect non-scalp body hair.
Study in Men with Hair Loss in the Anterior Mid-Scalp Area
A study of 12-month duration, designed to assess the efficacy of PROPECIA in men with hair loss in
the anterior mid-scalp area, also demonstrated significant increases in hair count compared with placebo.
PROPECIA? (Finasteride) Tablets, 1 mg
9328505
6
Increases in hair count were accompanied by improvements in patient self-assessment, investigator
assessment, and ratings based on standardized photographs. Hair counts were obtained in the anterior
mid-scalp area, and did not include the area of bitemporal recession or the anterior hairline.
Summary of Clinical Studies in Men
Clinical studies were conducted in men aged 18 to 41 with mild to moderate degrees of androgenetic
alopecia. All men treated with PROPECIA or placebo received a tar-based shampoo
(Neutrogena T/Gel
®
**
Shampoo) during the first 2 years of the studies. Clinical improvement was seen as
early as 3 months in the patients treated with PROPECIA and led to a net increase in scalp hair count and
hair regrowth. In clinical studies for up to 5 years, treatment with PROPECIA slowed the further
progression of hair loss observed in the placebo group. In general, the difference between treatment
groups continued to increase throughout the 5 years of the studies.
Ethnic Analysis of Clinical Data from Men
In a combined analysis of the two studies on vertex baldness, mean hair count changes from baseline
were 91 vs -19 hairs (PROPECIA vs placebo) among Caucasians (n=1185), 49 vs -27 hairs among
Blacks (n=84), 53 vs -38 hairs among Asians (n=17), 67 vs 5 hairs among Hispanics (n=45) and 67 vs -15
hairs among other ethnic groups (n=20). Patient self-assessment showed improvement across racial
groups with PROPECIA treatment, except for satisfaction of the frontal hairline and vertex in Black men,
who were satisfied overall.

Online Propecia
Study in Women
In a study involving 137 postmenopausal women with androgenetic alopecia who were treated with
PROPECIA (n=67) or placebo (n=70) for 12 months, effectiveness could not be demonstrated. There was
no improvement in hair counts, patient self-assessment, investigator assessment, or ratings of
standardized photographs in the women treated with PROPECIA when compared with the placebo group
(see INDICATIONS AND USAGE).

What are the possible side effects of PROPECIA?
Like all prescription products, PROPECIA may cause side effects. In clinical studies, side effects from
PROPECIA were uncommon and did not affect most men. A small number of men experienced certain
sexual side effects. These men reported one or more of the following: less desire for sex; difficulty in
achieving an erection; and, a decrease in the amount of semen. Each of these side effects occurred in
less than 2% of men. These side effects went away in men who stopped taking PROPECIA. They also
disappeared in most men who continued taking PROPECIA.
In general use, the following have been reported: allergic reactions including rash, itching, hives and
swelling of the lips and face; problems with ejaculation; breast tenderness and enlargement; and
testicular pain. You should promptly report to your doctor any changes in your breasts such as lumps,
pain or nipple discharge. Tell your doctor promptly about these or any other unusual side effects.
Page 3
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• PROPECIA can affect a blood test called PSA (Prostate-Specific Antigen) for the screening of
prostate cancer. If you have a PSA test done, you should tell your doctor that you are taking
PROPECIA.Tags:Online Propecia

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