| Highlights of Clinical Studies |
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5 years of clinical data showed the benefit of PROPECIA® (finasteride)
Measurements of hair counts in a 1-inch diameter circle in 2 vertex studies showed that ...
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PROPECIA works for most men: Most (65%) men treated with PROPECIA at Year 5 had increased hair count, while all men in the placebo group lost hair. |
View hair counts for men treated with PROPECIA or placebo throughout 5 years of study |
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Men who started treatment with placebo and were switched to PROPECIA 1 year later never caught up to the men who were treated with PROPECIA for the full 5 years. |
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The maximum improvement in hair count with PROPECIA compared to baseline was achieved during the first 2 years. |
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If PROPECIA has not maintained hair count or regrown visible hair within 12 months, further treatment is unlikely to be of benefit. Withdrawal of treatment leads to reversal of effect within 12 months. |
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At 5 years, the benefits of PROPECIA were also supported by:
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Patients |
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Based on a self-assessment, men treated with PROPECIA reported satisfaction with their hair, slowing of hair loss, and improvement in the appearance of their hair. |
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Investigators |
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The majority of men (77%) treated with PROPECIA were rated as having increased hair growth compared with 15% of men treated with placebo. |
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Expert panel of dermatologists |
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Global photographic assessment showed that 90% of the men treated with PROPECIA 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). |
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Each sexual side effect with PROPECIA occurred in <2% of men and was reversible during 5 years of use
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In clinical studies of 1 year for PROPECIA, each drug-related sexual adverse event occurred in less than 2% of men. Discontinuation due to drug-related sexual adverse experiences was 1.2% in the group treated with PROPECIA and 0.9% in the placebo-treated group. Reported drug-related sexual adverse experiences included decreased libido (1.8% vs 1.3%, placebo), erectile dysfunction (1.3% vs 0.7%, placebo), and ejaculation disorders (1.2% vs 0.7%, placebo), primarily decreased volume of ejaculate (0.8% vs 0.4%, placebo). Resolution occurred in the 1-year studies in men who discontinued therapy with PROPECIA due to these sexual side effects. The incidence of each of the above side effects decreased to <0.3% by the fifth year of treatment with PROPECIA.
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Indications
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PROPECIA is the first oral therapy indicated for the treatment of male pattern hair loss in MEN ONLY. Safety and efficacy were demonstrated 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. |
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PROPECIA is not indicated in women or children. |
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Contraindications
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PROPECIA is contraindicated in women when they are or may potentially be pregnant. Finasteride may cause abnormalities of the external genitalia of a male fetus of a pregnant woman. |
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PROPECIA is contraindicated in patients with hypersensitivity to any component of this medication. |
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Warnings
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Women should not handle crushed or broken PROPECIA tablets when they are pregnant or may potentially be pregnant because of the possibility of absorption of finasteride and the subsequent potential risk to a male fetus. 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. |
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