What is the Efficacy of Propecia?

A five-year study of men who had previously experienced moderate or mild hair loss, and who took Propecia found that two-thirds of the study participants taking 1 milligram of finasteride daily had at least some success regrowing hair.

In this particular study, 48 percent of the men who took Propecia had noticeable regrowth, while an additional 42 percent of the men experienced no further hair loss. Also, while finasteride works on both the hairline and the crown of the head, the crown experiences the best hair growth.

In a 10-year study conducted more recently, 118 men who were being treated with 1 milligram of finasteride daily for male pattern baldness, for the most part experienced stable hair growth over the course of the test. Of the 118 men involved, a full 86 percent had steady hair growth, with only 14 percent experiencing further hair loss.

Even better, 69 percent of these men taking finasteride who experienced the most hair growth in the first year of the study, went on to continue their good hair growth even after five years. Also, men over 30 years of age had the best response to the finasteride, possibly because the older men in the test had already lost more hair than the younger test subjects, and therefore had more hair to regrow.

The conclusion of the study is that hair growth results do not decrease over time when finasteride (Propecia) is taken regularly over a long period of time. This result even applies to men who are over 40-years-old and who would expect to experience significant male pattern baldness due to age and heredity.

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In the 10-year study, 5.9 percent of the men tested with 1 milligram of finasteride daily experienced side effects, including some sexual dysfunction. However, none of the 118 men in this study reported any breast enlargement or feelings of depression.

Clinical studies have not been done on the effects of Propecia upon men over 65 years of age. Therefore, it is unknown how effective finasteride is for geriatric patients. However, it is known that no adjustment of amount of Propecia taken is necessary for men over age 65.

Propecia helps maintain hair growth only as long as it is taken. Once a patient stops taking Propecia, the hair he grew while under the influence of this drug is lost within six to 12 months.

Propecia also has its off label uses, meaning that it is occasionally prescribed to patients for situations other than what the drug was originally marketed for. For example, Propecia is sometimes used to help chronic alcoholics deal with some of the symptoms of withdrawal. Also, Propecia is sometimes prescribed along with an estrogen as part of the hormone therapy treatment needed by transsexuals as they proceed from being male to becoming female.

Because finasteride is a weaker form of antiandrogen, a drug that helps block cell receptors from picking up certain chemicals, it is therefore not known just how effective finasteride is in transsexual hormone therapy.

In an attempt to save money, some men receive a prescription for the 5 milligram version of finasteride known as Proscar, and then split the tablets into several pieces. While this can be done, any broken pills or pill dust must be kept away from women who are pregnant or likely to become pregnant (see "Side Effects of Propecia" above).

The drug Propecia grew out of a 1974 study of a group of children in the Caribbean who genetically were of indeterminate sex, meaning they could not be identified as either male or female. These children were initially raised as females, but they grew male sex organs after puberty. Research showed that these children had a genetic mutation which prevented their bodies from producing enough of both dihydrotestosterone (DHT) and 5-alpha-reductase.

Besides delayed growth of male genitalia, the deficiency of these male hormones appeared in the form of underdeveloped prostates and the lack of male balding as these Caribbean children aged.

In 1975, researchers for the pharmaceutical company, Merck, began to experiment with the idea that they could produce a drug based on their research of these Caribbean children that reduced the levels of DHT in the average man's body, thereby creating an effective treatment for benign prostatic hyperplasia (BPH), or what is commonly known as an enlarged prostate.

By 1992, Merck received FDA approval for the 5 milligram version of finasteride, which they named Proscar and sold as a drug used to treat BPH. A noticeable side effect of Proscar was increased hair growth in men experiencing male pattern baldness. In 1997, Merck received FDA approval to market the 1 milligram version of finasteride, known as Propecia, to treat men who just wanted the drug to treat baldness. Merck's patent for Proscar expired in 2006, while their patent for Propecia expired in 2013.

Based on a growing body of evidence that some men suffer from permanent sexual dysfunction after taking Propecia, Merck, in April 2011, revised the warning on the leaflets distributed to patients and healthcare professionals in the United States to include the mention that erectile dysfunction problems may continue even after the patient stops taking Propecia. In April 2012, the warnings on the Merck leaflets distributed in the United States were changed again to include a more complete list of potential and persistent sexual problems, such as decreased sexual drive, orgasm disorders and problems with ejaculation.

The decision to strengthen the drug warning was based on the FDA review of 678 reported cases of men having sexual dysfunction problems after stopping Propecia. Although the FDA does not at this time recognize a direct connection between finasteride and sexual dysfunction, there is enough reported on a wide range of sexual problems to warrant the strengthening of the cautions listed for this drug.

Because of potential changes to the wording and warnings concerning Propecia, it is recommended that patients taking Propecia read the literature that comes with the drug each time they get their prescription refilled, to remain aware of further changes.