Adverse EventsTwenty-five percent (102/416) of subjects experienced a total of 169 adverse events that were classified by the investigator as having a reasonable possibility of being drug-related (7). Those drug-related adverse events having and inceidence > 5% within any treatment group are presented in Tale 2. Table 2: Percent (%) of Subjects with Drug-Related Adverse Events ( > 5% of Subjects Within Any Treatment Group) Avodart | Adverse Event | 0.05mg/day N=71 | 0.1mg/day N=72 | 0.5mg/day N=68 | 2.5mg/day N=71 | Finasteride 5mg/day N=70 | Placebo N=64 | | Any Adverse Event | 18 | 29 | 16 | 32 | 24 | 27 | | Altered (Decreased) Libido | 3 | 3 | 0 | 13 | 4 | 3 | | Impotence | 1 | 0 | 0 | 0 | 1 | 5 | | Headaches | 1 | 8 | 6 | 6 | 3 | 3 | | Nausea and Vomiting | 0 | 0 | 1 | 1 | 0 | 5 | | Malaise and Fatigue | 1 | 1 | 1 | 7 | 3 | 3 | | Abnormal Liver Function Tests | 3 | 1 | 0 | 0 | 0 | 5 | The most common drug-related adverse event were decreased lilbido experienced by 13% of subjects receiving Avodart 2.5 mg/day followed by headaches, experienced by 8% of the Avodart 0.1mg/day group and 6% by both the Avodart 0.5mg/day and 2.5 mg/day group. There were no serious adverse events that were considered drug-related. Partner Pregnancies Five partner pregnancies were reported during the study. One female partner spontaneously aborted (study subject was on placebo) and one had a partial placenta previa with subsequent delivery of a normal male infant (study subject was on Avodart 0.5 mg). The other three pregnancies wee normal and resulted in the births of two males (two subjects on "Avodart 0.5mg and one on Avodart 2.5mg) and one female (subject on Avodart 2.5mg). None of the infants had genital or other abnormalities at birth (7). Precaution Avodart Soft Gelatin Capsules should not be handled by a woman who is pregnant or who may become pregnant because of the potential for absorption of dutasteride and the subsequent potential risk to a developing male fetus. Avodart is contraindicated for use in women. Avodart has not been studied in women because preclinical data suggest that the suppression of circulation levles of dihydrotestosterone may inhibit the development of the external genital organs in a male fetus carried by a woman exposed to dutasteride (6) REV 0704 REFERENCES • Meidan VM, Touitou E. Treatments for androgenetic alopecial and alopecia areata: current options and future prospects. Drugs 2001;61:53-69. • Randall VA. Physiology and Pathophysiology of Androgenetic Alopecia. In: Endocrinology, 4 th ed. Volum 3. DeGrrot LJ and Jameson JL (editors). W.B. Saunders Co, Philadelphia PA, 2001,pages 2257-2268. • Rittmaster RS. Clinical relevance of testosterone and dihydortestosterone metabolism in women. Am J Med 1995;98 (Suppl 1A): 17S-21S. • Wilson Jd, Griffin Je, Russell DW. Steroid 5 alpha-reductale 2 deficiency. Endocr Rev 1993;13:1-14. • Rittmaster RS. Finasteride. N. Engl J Med 1994;330:120-125. • Prescribing Information for Avodart Ô . • Data on file (Dutasteride, GM2000/00244/00, Study ARIA2004 Report Synopsis, 2001). Enclosures: Product Information for Avodart Ô | 
