| Two Phase III, double-blind, placebo-controlled, randomized vertex studies |
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Efficacy was evaluated by 4 end points: hair count, patient self-assessment questionnaire, investigator assessment, and global photography. |
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Initial pivotal studies (Year 1): |
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1,553 men, aged 18 to 41, with mild to moderate, but not complete, hair loss of the vertex. |
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Extension studies (Years 2–5)1: |
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Patients were randomized to 1 of 4 groups through Year 2. At Year 3, patients in the finasteride/placebo group were switched back to finasteride and remained on that therapy throughout the subsequent extension studies (Years 4 and 5). All other groups remained on the same treatment. |
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Adapted from Kaufman KD et al1 with permission from John Libbey Eurotext.
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PROPECIA® (finasteride) 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. |
| Other studies |
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A 1-year Phase III study of the anterior mid-scalp with an open extension for an additional year |
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326 men with mild to moderate hair loss in the anterior mid-scalp with or without vertex balding. |
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Parallel design to the vertex studies with the same end points except:
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— Hair count taken in a 1-cm2 circle.
— Patients in the placebo group crossed over to PROPECIA for the extension study.
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Phototrichogram study4 |
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212 men, aged 18 to 40, with mild to moderate vertex hair loss were randomized to PROPECIA 1 mg or placebo for 1 year. |
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Macrophotographs were taken in a 1-cm2 circular area located at the anterior leading edge of the thinning area of the vertex at baseline, 6 months, and 1 year. |
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Hair weight study5 |
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66 men with male pattern hair loss were initially randomized to PROPECIA or placebo for a 48-week, double-blind, placebo-controlled study. 49 men continued in an extension study for an additional 48 weeks. |
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Hair samples were collected and weighed 6 weeks after randomization and every 6 weeks thereafter.
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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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