Photographic Assessment |
 |
 |
|
| In the longest reported
controlled clinical study of male pattern hair loss patients
ever conducted ... |
| The majority of men
treated with PROPECIA® (finasteride) showed
improvement or no visible hair loss |
|
|
Global
photographic assessment of the vertex by an expert panel of
dermatologists showed: |
|
|
 |
90% of the men treated with
PROPECIA at 5 years had improvement or no visible hair loss
(48% of patients improved, 42% had no visible hair loss) vs
25% of men in the placebo group (6% improved, 19% had no
visible hair loss). |
|
|
|
 |
|
|
|
|
BASELINE
YEAR 5 |
|
 |
|
 |
|
 |
|
 |
|
|
 |
|
 |
|
|
|
|
|
 |
|
 |
|
 |
|
 |
|
|
 |
|
 |
|
|
|
|
|
|
GREAT IMPROVEMENT
5% |
|
MODERATE IMPROVEMENT
21% |
|
SLIGHT IMPROVEMENT
22% |
|
NO VISIBLE HAIR LOSS
42% |
|
|
SLIGHT DECREASE
7% |
|
MODERATE DECREASE
3% |
|
|
|
|
 |
 |
Hair loss is a progressive
condition—those patients left untreated continued to lose
hair. |
|
|
|
The maximum improvement in
hair count with PROPECIA compared to baseline was achieved
during the first 2 years. |
Selected Safety Information |
| |
 Selected
Safety Information
|
|
|
 |
|
| In the longest reported
controlled clinical study of male pattern hair loss patients
ever conducted ... |
| Each drug-related
sexual side effect with PROPECIA® (finasteride)
was <2% and reversible during 5 years of use1 |
 |
These side effects went
away in all men who stopped taking PROPECIA because of them. |
|
|
The incidence of each of
these side effects decreased to <0.3% by the fifth
year of treatment with PROPECIA. |
|
|
|
|
|
No significant
difference was seen in overall satisfation with sex life
based on patient-completed, self-administered questionnaire
to detect more subtle changes in sexual function; results
were consistent with the above table. |
|
|
|
|
PROPECIA is not
an antiandrogen. |
|
|
— |
Clinical studies showed men
treated with PROPECIA had increased mean testosterone and
estradiol levels (approximately 15%), but these levels were
within normal physiologic range. |
|
|
|
|
Exposure of
pregnant women to semen from men treated with PROPECIA poses
no risk to the fetus. |
Important Information About PROPECIA
 |
PROPECIA is
the first and only FDA-approved oral treatment for male
pattern hair loss in MEN ONLY. Safety
and efficacy were established in men, aged 18 to 41,
with mild to moderate hair loss of the vertex and
anterior mid-scalp area. Efficacy in bitemporal
recession has not been established. PROPECIA is not
indicated in women or children. |
|
Women who
are or may potentially be pregnant must not use PROPECIA
nor should they handle crushed or broken PROPECIA
tablets because finasteride may cause abnormalities of
the external genitalia of a male fetus. |
|
In a study
of postmenopausal women with androgenetic alopecia, the
effectiveness of PROPECIA could not be demonstrated. |
|
PROPECIA
tablets are coated and will prevent contact with the
active ingredient during normal handling, provided that
the tablets have not been broken or crushed. |
|
In clinical
studies, each drug-related sexual adverse event, which
included decreased libido, erectile dysfunction, and
ejaculation disorders, occurred in
<2% of men at 12 months. These side effects went
away in all men who stopped taking PROPECIA because of
them. The incidence of each of these side effects
decreased to <0.3% by the fifth year of
treatment. |
|
Postmarketing adverse events include breast tenderness
and enlargement; hypersensitivity reactions including
rash, pruritus, urticaria, and swelling of the lips and
face; and testicular pain. |
|
Further
treatment is unlikely to be of benefit if the drug has
not worked within 12 months. |
|
Stopping
treatment leads to a gradual reversal of the beneficial
effects within 12 months. |
|
No dosage
adjustments needed, regardless of age or renal function.
Caution should be used in patients with liver function
abnormalities, as finasteride is metabolized extensively
in the liver. |
|
No drug
interactions of clinical importance have been
identified. |
|
|
— |
Compounds that have
been tested in men include antipyrine, digoxin,
propranolol, theophylline, and warfarin, and no
interactions were found. |
|
In men
older than 41 undergoing a PSA test while taking
PROPECIA, consideration should be given to doubling the
PSA level. In men younger than 40, PSA is not routinely
measured. In clinical studies with PROPECIA in men 18 to
41 years of age, the mean value of serum
prostate-specific antigen (PSA) decreased from 0.7 ng/mL
at baseline to 0.5 ng/mL at Month 12. When finasteride
is used in older men who have benign prostatic
hyperplasia (BPH), PSA levels are decreased by
approximately 50%. |
|
Photos
from Clinical Trials | Propecia FAQ
| Results from clinical
Studies | Charity Challenge
| Propecia Press
Propecia
Long Term Test
Europe and
UK |
Worldwide
|
| |
Propecia
- 5 Year Results |
Difference over 5
years 
