Clinical Studies for PROPECIA ( finasteride 1 mg
) in the Treatment of Male Pattern Hair Loss
In controlled clinical trials for PROPECIA of 12-month
duration, 1.4% of the patients were discontinued due to
adverse experiences that were considered to be possibly,
probably or definitely drug-related ( 1.6% for placebo );
1.2% of patients on PROPECIA and 0.9% of patients on placebo
discontinued therapy because of a drug-related sexual adverse
experience. The following clinical adverse reactions were
reported as possibly, probably or definitely drug-related
in >1% of patients treated for 12 months with
PROPECIA or placebo, respectively: decreased libido ( 1.8%,
1.3% ), erectile dysfunction ( 1.3%, 0.7% ) and ejaculation
disorder ( 1.2%, 0.7%; primarily decreased volume of ejaculate:
[0.8%, 0.4%] ). Integrated analysis of clinical adverse
experiences showed that during treatment with PROPECIA,
36 ( 3.8% ) of 945 men had reported one or more of these
adverse experiences as compared to 20 ( 2.1% ) of 934 men
treated with placebo ( p=0.04 ). Resolution occurred in
men who discontinued therapy with PROPECIA due to these
side effects and in most of those who continued therapy.
The incidence of each of the above side effects decreased
to < 0.3% by the fifth year of treatment with
PROPECIA.
In a study of finasteride 1 mg daily in healthy men,
a median decrease in ejaculate volume of 0.3 mL ( -11%
) compared with 0.2 mL ( –8% ) for placebo was observed
after 48 weeks of treatment. Two other studies showed that
finasteride at 5 times the dosage of PROPECIA ( 5 mg
daily ) produced significant median decreases of approximately
0.5 mL ( -25% ) compared to placebo in ejaculate volume
but this was reversible after discontinuation of treatment.
In the clinical studies with PROPECIA, the incidences for
breast tenderness and enlargement, hypersensitivity reactions,
and testicular pain in finasteride-treated patients were
not different from those in patients treated with placebo.
Postmarketing Experience for PROPECIA ( finasteride
1 mg )
Breast tenderness and enlargement; hypersensitivity reactions
including rash, pruritus, urticaria, and swelling of the
lips and face; and testicular pain.
Controlled Clinical Trials and Long-Term Open Extension
Studies for PROSCAR* ( finasteride 5 mg ) in the Treatment
of Benign Prostatic Hyperplasia
In controlled clinical trials for PROSCAR of 12-month duration,
1.3% of the patients were discontinued due to adverse experiences
that were considered to be possibly, probably or definitely
drug-related ( 0.9% for placebo ); only one patient on PROSCAR
( 0.2% ) and one patient on placebo ( 0.2% ) discontinued
therapy because of a drug-related sexual adverse experience.
The following clinical adverse reactions were reported as
possibly, probably or definitely drug-related in >1%
of patients treated for 12 months with PROSCAR or placebo,
respectively: erectile dysfunction ( 3.7%, 1.1% ), decreased
libido ( 3.3%, 1.6% ) and decreased volume of ejaculate
( 2.8%, 0.9% ). The adverse experience profiles for patients
treated with finasteride 1 mg/day for 12 months and
those maintained on PROSCAR for 24 to 48 months were similar
to that observed in the 12-month controlled studies with
PROSCAR. Sexual adverse experiences resolved with continued
treatment in over 60% of patients who reported them.
*Registered trademark of Merck & Co., Inc.
