The marketing clearance of Propecia is based on data from three one-year, double-blind, placebo-controlled, multicenter clinical trials involving 1,879 men aged 18 to 41 with mild to moderate hair loss of the vertex and anterior mid-scalp areas. In addition, 1,215 of the men who had hair loss at the vertex, or top of the head, were studied for another year.
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. In an analysis of the men who were followed for up to two years, only 17 percent of men treated with Propecia demonstrated hair loss (defined as any decrease in hair count from baseline); 83 percent had the same or higher hair count. In contrast, 72 percent of the placebo group lost hair, as measured by hair count. Through questionnaires, all patients were asked to evaluate their response to treatment. Those on Propecia reported an increase in the amount of hair, a decrease in hair loss, and improvement in appearance. Clinical improvement was seen as early as three months.
In another analysis, a panel of independent dermatologists evaluated photos in 508 patients after 24 months of treatment. An increase in hair growth was demonstrated in 66 percent of men treated with Propecia compared to 7 percent of men treated with placebo. Efficacy in bitemporal recession has not been established. All men, whether receiving Propecia or placebo, were given a medicated shampoo (Neutrogena T/Gel Shampoo).
“Propecia works by inhibiting the conversion of testosterone to DHT (dihydro-testosterone),” said Keith Kaufman, M.D., senior director, Clinical Research, Merck Research Laboratories in Rahway, N.J. “It is the first treatment to target this key factor in the development of androgenetic alopecia in those patients genetically predisposed.”
Cautionary Information for Women
Propecia is for use by men only. It is not for use in women or children. Women must not use Propecia when they are or may potentially be pregnant because it may cause abnormalities of the male baby’s sex organs, a condition known as hypospadias. In addition, women should not handle crushed or broken tablets when they are pregnant or may potentially be pregnant. Propecia tablets have a coating that will prevent contact with the active ingredient during normal handling, provided that the tablets have not been broken or crushed.
Side Effects: Uncommon
In clinical studies, side effects were uncommon and did not affect most men. A 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 effects occurred in less than 2 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.
Merck’s catalog price to wholesalers and direct purchasers for Propecia will be $1.25 per tablet. Merck estimates that the retail price for Propecia will be between $45 to $49 per month, based on historical markups at the retail level. Prices at the retail level are established by pharmacies, not by Merck, and can vary. Propecia will be available in bottles of 30 and in special ProPak(TM) convenience packages that feature a three-month supply, a $10 patient rebate and an informational patient brochure.
Merck & Co., Inc. is a leading research-driven pharmaceutical products and services company. Merck discovers, develops and markets a broad range of innovative products to improve human health and quality of life.
Rogaine – (Minoxidil)
Rogaine Extra Strength contains 5% Minoxidil, the only FDA approved topical treatment for hair loss. In clinical studies, four out of five users claimed Rogaine helped slow or stop their hair loss. Rogaine Extra Strength has 45% more regrowth than regular strength. This means that there is enhanced penetration of the hairs follicle and significantly more hair growth – results may occur in as soon as 2 months.
Rogaine is a topical liquid, not a systemic medication. That means it’s applied to the top of your scalp, instead of taken internally. You’ll be relieved to know that Men’s Rogaine Extra Strength works without altering male hormones.
A small percentage of users, about 6%, experience scalp irritation.
Rogaine is applied directly to the scalp in the hair loss area twice daily; for example, once in the morning and once at night. The night-time application should occur 2-4 hours before bed to allow for drying. Each bottle should last about 25-30 days, if used as directed. Hair can be styled normally after the Rogaine had dried. The twinpack contains 2 month’s supply of Rogaine
Rogaine Extra Strength is not for use by women
Rogaine For Women
Rogaine for Women Hair Regrowth Treatment – Rogaine contains 2% Minoxidil, the only FDA approved treatment for hair loss. In clinical studies, four out of five users claimed Rogaine helped slow or stop their hair loss.
Rogaine is applied directly to the scalp in the hair loss area twice daily; for example, once in the morning and once at night. The night-time application should occur 2-4 hours before bed to allow for drying. Each bottle should last about 25-30 days, if used as directed. Hair can be styled normally after the Rogaine had dried.
Since normal hair grows only 1/2 to 1 inch per month, hair regrowth with Rogaine takes some time. Continued use of Rogaine twice a day for at least four months is usually needed before you notice hair regrowth. You will need to continue use of Rogaine to maintain the hair regrowth.