Propecia (Finasteride) - Summary

PROPECIA SUMMARY

What is PROPECIA used for?

PROPECIA (finasteride), a synthetic 4-azasteroid compound, is a specific inhibitor of steroid Type II 5(alpha)-reductase, an intracellular enzyme that converts the androgen testosterone into 5(alpha)-dihydrotestosterone (DHT).

PROPECIA is indicated for the treatment of male pattern hair loss (androgenetic alopecia) in MEN ONLY. Safety and efficacy were demonstrated in men between 18 to 41 years of age with mild to moderate hair loss of the vertex and anterior mid-scalp area (see CLINICAL PHARMACOLOGY, Clinical Studies).

Efficacy in bitemporal recession has not been established.

PROPECIA is not indicated in women (see CLINICAL PHARMACOLOGY, Clinical Studies and CONTRAINDICATIONS).

PROPECIA is not indicated in children (see PRECAUTIONS, Pediatric Use).

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NEWS HIGHLIGHTS

Published Studies Related to Propecia (Finasteride)

PCPT: Evidence that finasteride reduces risk of most frequently detected intermediate- and high-grade (Gleason score 6 and 7) cancer. [2009.05]
OBJECTIVES: To determine the effect of finasteride relative to placebo on prostate cancer (PCa) risk at each individual Gleason score in the Prostate Cancer Prevention Trial using a post hoc generalization of a prespecified, exploratory, biopsy sampling density-adjusted analysis... CONCLUSIONS: After adjusting for biopsy sampling density, finasteride significantly reduced the PCa risk relative to placebo across multiple Gleason scores in the Prostate Cancer Prevention Trial, including the most frequently detected intermediate- and high-grade cancers (Gleason scores 6 and 7).

Effects of short-term finasteride on apoptotic factors and androgen receptors in prostate cancer cells. [2009.02]
PURPOSE: We explored the molecular correlates of the effect of finasteride on prostate tissue in patients undergoing radical prostatectomy... CONCLUSIONS: Finasteride administered 30 days before surgery appears to decrease the apoptotic factors caspase-7 and IGFBP-3 in cancer cells, while having little to no effect on caspase-3, insulin growth factor-1, bcl-2, p53 and p21. This short-term study may have interesting implications for interpreting Prostate Cancer Prevention Trial data on the molecular level. No differences were noted between the treatment and placebo groups in the expression of nuclear androgen receptor. However, decreased expression of androgen receptors was present in cancer cells compared to that in benign prostate cells in the 2 groups.

Long-term treatment with finasteride results in a clinically significant reduction in total prostate volume compared to placebo over the full range of baseline prostate sizes in men enrolled in the MTOPS trial. [2008.09]
PURPOSE: In the present analysis we examined data from the MTOPS (Medical Therapy of Prostatic Symptoms) trial to determine the effect of long-term finasteride treatment, either alone or in combination with doxazosin, on total prostate volume across the full range of baseline total prostate volume values in men enrolled in this study... CONCLUSIONS: In this MTOPS data analysis long-term (more than 4 years) treatment with finasteride, either alone or in combination with doxazosin, led to a consistent, clinically significant reduction in total prostate volume compared to placebo in patients with lower urinary tract symptoms and benign prostatic hyperplasia whose baseline prostate size ranged from relatively small (less than 25 to 30 ml) to enlarged (40 ml or greater).

Finasteride does not increase the risk of high-grade prostate cancer: a bias-adjusted modeling approach. [2008.08]
Finasteride taken for 7 years in the Prostate Cancer Prevention Trial (PCPT) reduced the risk of prostate cancer by 25%, but with an apparent increased risk of high-grade disease. Subsequent analyses found that finasteride biases toward improved prostate cancer detection and accuracy in prostate cancer grading at biopsy...

The effect of 5alpha-reductase inhibition with dutasteride and finasteride on bone mineral density, serum lipoproteins, hemoglobin, prostate specific antigen and sexual function in healthy young men. [2008.06]
PURPOSE: Dutasteride and finasteride are 5alpha-reductase inhibitors that dramatically decrease serum levels of dihydrotestosterone. Because androgens affect bone, lipids, hematopoiesis, prostate and sexual function, we determined the impact of 5alpha-reductase inhibitors on these end points... CONCLUSIONS: Profound suppression of circulating serum dihydrotestosterone induced by 5alpha-reductase inhibitors during 1 year does not adversely impact bone, serum lipoproteins or hemoglobin, and has a minimal, reversible effect on serum prostate specific antigen and sexual function in normal men. Circulating dihydrotestosterone does not appear to have a clinically significant role in modulating bone mass, hematopoiesis or lipid metabolism in normal men.

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Clinical Trials Related to Propecia (Finasteride)

A Phase III, Randomized, Double-Blind, Placebo-Controlled Trial of Proscar in Men With Initial Negative Prostate Biopsies [Not yet recruiting]
Twenty percent of men with an initial negative prostate biopsy are found to have cancer on a repeat biopsy. finasteride (a 5-ARI) reduces prostate volume and improves the utility of PSA and DRE. thus, six months of finasteride may improve the detection rate of prostate cancer in men with an initial negative biopsy.

Randomized, Double-Blind, Placebo-Controlled Trial of Preoperative Finasteride in Patients Undergoing Transurethral Resection of The Prostate [Not yet recruiting]
Transurethral resection of the prostate (TURP) is a common treatment for benign prostatic hyperplasia (BPH). a common complication of TURP is blood loss. preliminary data suggest that preoperative finasteride, a 5a-reductase inhibitor, may reduce blood loss during TURP. however, no study has examined the effect of preoperative finasteride on clinical outcomes.

On Label, Randomized, Double-Blind, Placebo-Controlled Trial of Preoperative Finasteride in Patients Undergoing Transurethral Resection of the Prostate (TURP) [Active, not recruiting]
Transurethral resection of the prostate (TURP) is a common treatment for benign prostatic hyperplasia (BPH). A common complication of TURP is blood loss. Preliminary data suggest that preoperative Finasteride, a 5 alpha-reductase inhibitor, may reduce blood loss during TURP. However, no study has examined the effect of preoperative Finasteride on clinical outcomes.

The study is a randomized, double-blind, placebo-controlled trial of preoperative Finasteride versus placebo in BPH patients undergoing TURP. Participants will be stratified by prostate volume (30 to 65 grams versus 66 to 100 grams) and randomly assigned to preoperative Finasteride or placebo. The primary end point is incidence of RBCT. Secondary end points are standard units of red blood cells transfused, variables related to perioperative bleeding (incidence of readmission, incidence of return to hospital, length of hospital stay), blood loss, change in serum hemoglobin, change in serum hematocrit, blood loss per gram of resected prostate tissue, operating time, change in AUA-SS, and change in HRQOL.

Fed Study of Finasteride Tablets 5 mg and Proscar® Tablets 5 mg [Completed]
The objective of this study was to investigate the bioequivalence of Mylan's finasteride 5 mg tablets and Merck's Proscar® 5 mg tablets following a single, oral 5 mg (1 x 5 mg) dose administration under fed conditions.

Fasting Study of Finasteride Tablets 5 mg and Proscar Tablets 5 mg [Completed]
The objective of this study was to investigate the bioequivalence of Mylan's finasteride 5 mg tablets to Merck's Proscar® 5 mg tablets following a single, oral 5 mg (1 x 5 mg) dose administration under fasting conditions.

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PATIENT REVIEWS / RATINGS / COMMENTS

Propecia review by 49 year old male patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		No Side Effects
		Treatment Info
Condition / reason:		hair loss
Dosage & duration:		standard (dosage frequency: once a day) for the period of 3 years
Other conditions:		none
Other drugs taken:		none
		Reported Results
Benefits:		Hair regrowth in crown area
Side effects:		there were none
Comments:		One pill taken orally daily

Propecia review by 19 year old male patient
		Rating
Overall rating:
Effectiveness:		Moderately Effective
Side effects:		No Side Effects
		Treatment Info
Condition / reason:		Hair Loss
Dosage & duration:		1mg taken daily for the period of I'm still taking it..
Other conditions:		none
Other drugs taken:		none
		Reported Results
Benefits:		I found that the Propecia did seem to counteract my hair loss. However, it did not do much for the hair I had already lost. I've been taking it for three years now and I have not seen any more receding, and my hair seems thicker than it used to be.
Side effects:		They say that a major side effect could be impotence and a loss of sexual desire, but I did not experience either of those. Other than that, I can not really think of any other side effects I have experienced with Propecia over the last three years.
Comments:		I take one pill each day. Sometimes when my prescription runs out, I am forced to miss a few days, but I do not notice any changes as I think the medicine takes a longer time to work and stop working. I've worked it into my daily routine and although I do not like having to take a pill every day at 22 it has not been a problem.

Propecia review by 31 year old male patient
		Rating
Overall rating:
Effectiveness:		Ineffective
Side effects:		Extremely Severe Side Effects
		Treatment Info
Condition / reason:		male pattern bladness
Dosage & duration:		1 mg/day taken once per day for the period of about 8 months
Other conditions:		none
Other drugs taken:		none
		Reported Results
Benefits:		There were no benefits that I could perceive. The hairloss continued but worst of all the side-effects from this drug are severe and permanent. This is very disturbing!
Side effects:		Sexual Dysfunction, depression, swelling, fatigue, redness and insomnia. These side-effects were SEVERE and PERMANENT.
Comments:		This drug should NOT be on the market!