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| |  Results Of New Study Confirm Propecia Works Only In Men WEST POINT, PA -- May 4, 1998 -- New research presented this weekend at an international hair loss workshop in Brussels, Belgium, has determined that Merck & Co., Inc.’s Propecia(R) (finasteride 1 mg), the once-a-day pill to treat certain types of men's hair loss, is not an effective treatment for women with hair loss. The results of a one-year study in 136 women showed that there was no significant difference in the change in mean hair count at 12 months between post-menopausal women treated with Propecia and those given a placebo. The United States Food and Drug Administration cleared Propecia for marketing in December 1997 for men only. In clinical studies over 1,800 men, 18 to 41, with mild to moderate male pattern hair loss on the vertex (at the top of the head) and anterior mid-scalp area were treated for up to two years. In these studies, hair count increased during the first year and was maintained in those men taking Propecia for 24 months. Men in the placebo group continued to show progressive hair loss. Although the differences in the factors that cause hair loss in men and women are not fully understood, Joanne Waldstreicher, M.D., senior director of clinical research, Merck Research Laboratories, said women normally have lower levels of androgens (male sex hormones, such as testosterone and dihydrotestosterone) than men. Propecia blocks the conversion of testosterone to dihydrotestosterone and, by this mechanism, appears to interrupt a key factor in the development of androgenetic alopecia in men who are genetically predisposed. Preliminary efficacy data from this new study are available on 65 women (mean age 53.2) in the group treated with Propecia and 69 women (mean age 52.6) in the group given a placebo, or sugar pill. Hair counts were obtained from a one centimetre square area (approximately 0.155 square inch) in the anterior and mid-area portion of the scalp at baseline, six months and 12 months. Of the women in the trial, 73 were on hormone replacement therapy as well. The use of hormone replacement therapy did not affect the outcome of the study. Results of the study showed that: The difference between the treatment and placebo groups was not statistically significant. In addition, global photographs of the scalp were reviewed by a blinded panel of dermatologists. Analysis of these photographs revealed no significant difference in results between the placebo group and the group treated with Propecia. "With no demonstrated efficacy and the known risks of Propecia in women who are or may potentially be pregnant, this study establishes that Propecia should be used in men only," Dr. Waldstreicher added. Women who are or may potentially be pregnant must not use Propecia and should not handle crushed or broken tablets because it may cause abnormalities of the male baby's sex organs. Propecia tablets are coated and will prevent contact with the active ingredient during normal handling, provided the tablets have not been broken or crushed. In an earlier analysis of 1,215 men with hair loss in the vertex area of the scalp who were followed for up to two years, 83 percent had the same or higher hair count versus 28 percent of the placebo group. Most men reported an increase in the amount of their hair, a decrease in hair loss and improvement in appearance. There is not sufficient evidence that Propecia works for recession at the temporal areas. Men may need to take Propecia daily for three months or more to see visible results. In clinical studies in men, Propecia was generally well-tolerated and side effects were uncommon. A very small number of men reported less desire for sex, difficulty in achieving an erection and/or a decrease in the amount of semen. Each of these side effects occurred in less than two percent of men. These side effects went away in all men who discontinued therapy because of them and also disappeared in 58 percent of men who chose to continue taking Propecia. More information on: Propecia, Merck & Co., Inc..
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