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PubMed2003

A comparison of the efficacy and tolerability of tamsulosin and finasteride in patients with lower urinary tract symptoms suggestive of benign prostatic hyperplasia.

In this multicentre, double-blind study, patients with LUTS/BPH were randomised to 26 weeks with finasteride 5 mg once daily (n=204) or tamsulosin 0.4 mg once daily (n=199). Double-blind treatment was continued for another 26 weeks (total treatment duration: 1 y). The primary efficacy parameter was the difference in mean change in total Symptom Problem Index (SPI) from baseline to end point at week-26 in the intention-to-treat (ITT) and per protocol (PP) populations. Tamsulosin induced a greater improvement in total SPI (-5.2 points or -37%) compared to finasteride (-4.5 points or -31%) at week-26 (P=0.055 in ITT and P=0.032 in PP). Tamsulosin improved urinary symptoms (particularly the more bothersome storage symptoms) and flow more quickly than finasteride. The difference was statistically significant for the SPI from week-1 (reduction, respectively, -2.5 vs -1.8 points, P=0.043) to week-18 and for Qmax from week-1 (increase, respectively, 2.3 vs 0.7 ml/s, P=0.0007) to week-12. Both treatments were well tolerated with a comparable incidence of adverse events, including urinary retention.

Aged↗
PubMed1998

Finasteride blocks the reduction in ictal activity produced by exogenous estrous cyclicity.

The purpose of the present study was to examine seizure activity during reduced 5alpha-pregnan-3alpha-ol-20-one (3alpha,5alpha-THP) production. Ovariectomized Long-Evans rats were stereotaxically implanted with bipolar electrodes above the perforant pathway; silastic implants filled with estradiol-17-benzoate (EB) and progesterone were inserted subcutaneously to mimic diestrus. Estrus was then induced in half of these animals by injection of EB (30 microg) and progesterone (2.5 mg), 48 and 4 h, respectively, prior to perforant pathway stimulation. Half of the estrous and diestrous rats also received a 5alpha-reductase inhibitor, finasteride (50 mg/kg), 6 h prior to perforant pathway stimulation. The estrous condition was associated with reduced number and duration of partial seizures, improved performance on a Morris water maze recovery of function test, reduced neuronal loss in the hilar region of the hippocampus, and elevated central and plasma 3alpha,5alpha-THP, compared to estrus+finasteride, diestrus+vehicle and diestrus+finasteride conditions, which did not differ from each another. These data suggest antiseizure effects of estrus may be caused, in part, by the action of 3alpha,5alpha-THP and that the precipitous decline in 3alpha,5alpha-THP may restore seizure threshold to control levels.

5-alpha Reductase Inhibitors↗
PubMed1996

Anti-androgenic effects of combination finasteride plus flutamide in patients with prostatic carcinoma.

OBJECTIVES: To determine the anti-androgenic effects and safety of the combination of finasteride and flutamide in men with prostate cancer. PATIENTS AND METHODS: Seventeen men with various stages of prostate cancer, all of whom were candidates for androgen deprivation therapy, were treated with finasteride plus flutamide and were followed for a mean of 13.6 months using measurements of serum prostate specific antigen (PSA), and an assessment of regression and side-effects. RESULTS: The initial median PSA level was 19.8 ng/mL: at 3, 6 and 12 months the median PSA had fallen to 1.2, 0.85 and 0.8 ng/mL, respectively. In four patients followed for 2 years, the anti-neoplastic effects were sustained. Patients with initially palpable disease had regression, as assessed by a digital rectal examination. Side-effects included gynaecomastia (five patients), mildly elevated hepatic transaminases (two) and diarrhoea (one). Most men maintained their previous sexual function. CONCLUSIONS: Early results suggest that the combination of finasteride and flutamide provides significant anti-androgenic therapy and maintains sexual function in most men. A further investigation with more patients and a longer follow-up is warranted.

Aged↗
PubMed2001

A double-blind, randomized, placebo-controlled pilot study to investigate the effects of finasteride combined with a biodegradable self-reinforced poly L-lactic acid spiral stent in patients with urinary retention caused by bladder outlet obstruction from benign prostatic hyperplasia.

OBJECTIVE: To assess whether patients in acute urinary retention from benign prostatic enlargement can be treated with a combined therapy comprising finasteride and a bioabsorbable self-reinforced poly L-lactic acid (SR-PLLA) urethral stent. PATIENTS AND METHODS: Fifty-five patients in acute urinary retention were treated as outpatients; they had a suprapubic catheter inserted and the SR-PLLA stent placed cystoscopically. After 2 weeks the patients were randomized to receive either finasteride 5 mg daily or placebo. They were assessed at baseline and at 6, 12 and 18 months for maximum urinary flow rate, prostate volume and serum prostate-specific antigen (PSA). RESULTS: Nineteen patients completed the study while 36 discontinued. There was a statistically significant increase in the mean maximum flow rate, and a statistically significant decrease in the prostatic volume and serum PSA in the finasteride group. The same number of patients discontinued in both groups; the major reason for discontinuation was insufficient therapeutic response. CONCLUSIONS: The major problems were discontinuation of treatment because the response to therapy was insufficient, and uncontrolled breakdown of the spiral stent. To solve these problems, new configurations of bioabsorbable stents are needed.

Absorbable Implants↗
PubMed2005

Bioequivalence study of two different coated tablet formulations of finasteride in healthy volunteers.

This study was conducted in order to assess the bioequivalence of two different coated tablet formulations containing 5 mg finasteride (CAS 98319-26-7). Twenty-six healthy volunteers were enrolled in an open, randomised, crossover single dose study with 2 periods x 2 sequences and a minimum washout period of 7 days. Plasma samples were obtained over 24 h (at baseline, +0.5 h, +1 h, +1.5 h, +2 h, +2.5 h, +3 h, 3.5 h, +4 h, +4.5 h, +5 h, +6 h, +8 h, +10 h, +12 h, +16 h and +24 h after administration). Finasteride levels were determined by high-pressure liquid chromatography with tandem mass detection, HPLC-MS/ MS, (LOQ 0.50 ng/mL). Pharmacokinetic parameters used for bioequivalence assessment (AUClast and Cmax were main evaluation criteria, however, AUCinf was also analysed) were determined from the finasteride concentration data using non-compartmental analysis. The 90 % confidence intervals (obtained by ANOVA) were 86.31-98.69 for Cmax, 95.40-104.88 for AUClast and 96.20-105.81 for AUCinf that is, they were all within the predefined ranges. It may be therefore concluded that the evaluated formulations are bioequivalent in terms of rate and extent of absorption.

Adolescent↗
PubMed2001

Bioequivalence study of finasteride. Determination in human plasma by high-pressure liquid chromatography coupled to tandem mass spectrometry.

Two different finasteride (CAS 98319-26-7) tablet formulations were evaluated for their relative bioavailability (Flaxin tablets 5 mg, as the test formulation vs reference formulation, tablets 5 mg) in 23 healthy male volunteers who received a single 5 mg oral dose of each preparation. The study was open, randomized with a two-period crossover design and a 7-day washout period. Plasma samples were obtained over a 48-h interval. The finasteride concentrations were determined by high-pressure liquid chromatography (HPLC) coupled to tandem mass spectrometry (LC-MS-MS). The analytical method developed has a limit of quantitation (LOQ) of 0.50 ng/ml in plasma. For the quality control the measured concentration was 2.05 +/- 0.14 ng/ml (mean +/- SD, n = 30) with a precision of 6.9% and an accuracy of 2.55% at a concentration of the starting solution of 2.00 ng/ml, while with 20.00 ng/ml starting solution the measured concentrations were 20 +/- 0.80 ng/ml (n = 30) with a precision of 3.81% and an accuracy of 0.09%. From the plasma finasteride concentration vs time curves the following pharmacokinetics parameters were obtained: AUC0-48, AUC0-infinity, Cmax, Cmax/AUC0-48, Ke, elimination half-life and tmax. Geometric mean test/reference formulations individual percent ratio was 95.71 for AUC0-48 h and 88.70% for Cmax. The 90% confidence interval for the geometric mean of the individual ratio test/reference formulations was 95.70-120.20% for AUC0-48 h, 94.60-121.30 for AUC0-infinity and 88.70-108% for Cmax. Since for both Cmax or AUC the 90% Cl values are within the interval proposed by the Food and Drug Administration, the test formulation is bioequivalent to the reference formulation for both the rate and extent of absorption after single dose administration.

5-alpha Reductase Inhibitors↗
PubMed2002

Hair loss in women with hyperandrogenism: four cases responding to finasteride.

Oral finasteride, a type II 5 alpha-reductase inhibitor, has been shown to increase hair growth and slow progression of thinning in men with androgenetic or male pattern balding (Hamiliton type) but has no affect on hair growth in postmenopausal women with female pattern hair loss (Ludwig type). We describe 4 cases of hair loss with characteristics of both male and female patterns in women with hyperandrogenism in which finasteride has improved or stabilized the alopecia. Improved hair growth was seen after 6 months, 1 year, 2 years, and 2.5 years, respectively. The finding that finasteride treatment improves pattern hair loss in women with hyperandrogenism but does not affect those postmenopausal women with female pattern hair loss without hyperandrogenism supports the concept that not all types of female hair loss have the same pathophysiology.

Aged↗
PubMed2004

Finasteride and bicalutamide as primary hormonal therapy in patients with advanced adenocarcinoma of the prostate.

BACKGROUND: Medical or surgical castration is effective in advanced prostate cancer but with profound side-effects, particularly on sexual function. Effective, less toxic therapies are needed. This study examined whether the addition of finasteride to high-dose bicalutamide enhanced disease control, as measured by additional decreases in serum prostate-specific antigen (PSA). PATIENTS AND METHODS: Forty-one patients with advanced prostate cancer received bicalutamide (150 mg/day). Finasteride (5 mg/day) was added at first PSA nadir. Serum PSA was measured every 2 weeks until disease progression. Questionnaires were administered to assess sexual function. RESULTS: Median follow-up is 3.9 years. At the first PSA nadir, median decrease in PSA from baseline was 96.5%. Thirty of 41 patients (73%) achieved a second PSA nadir and median decrease of 98.5% from baseline. Median time to each nadir was 3.7 and 5.8 weeks, respectively. Median time to treatment failure was 21.3 months. Toxicities were minor, including gynecomastia. Seventeen of 29 (59%) and 12 of 24 (50%) men had normal sex drive at baseline and at second PSA nadir, respectively. One-third of men had spontaneous erection at both time points. CONCLUSION: Finasteride provides additional intracellular androgen blockade when added to bicalutamide. Duration of control is comparable to castration, with preserved sexual function in some patients.

Adenocarcinoma↗
PubMed2002

Depression circumstantially related to the administration of finasteride for androgenetic alopecia.

In this paper we report 19 patients (14 males, 5 females; mean age 28.16 years +/- 7.68 SD) out of a series of 23 (17 males, 5 females) who developed a mood disturbance (moderate to severe depression) during treatment with finasteride, 1 mg/day orally, for androgenetic alopecia (Hamilton subtypes III-V; Ludwig subtypes I-II). Depression, which significatively impaired sociofamilial relations, sleep and eating behaviour, was associated to marked anxiety in some cases, developed after 9-19 weeks of treatment with finasteride, and promptly resolved after suspension of the drug. Two patients accepted reintroduction of the drug, and depression relapsed within 2 weeks. Depression as an adverse effect of finasteride has been reported only once. Further studies are needed to confirm our circumstantial observations, which are based on a retrospective series of patients.

5-alpha Reductase Inhibitors↗
PubMed1992

Finasteride in the treatment of benign prostatic hyperplasia. A urodynamic evaluation.

A group of 69 men with bladder outflow obstruction due to benign prostatic hyperplasia (BPH) were treated in a double-blind, placebo-controlled study with finasteride (Proscar, MK-906), a 5-alpha reductase inhibitor, 5 mg or 10 mg/day or placebo for 3 months; subsequently, 20 patients received finasteride 5 mg/day for a further 9 months in an open extension study. In treated patients dihydrotestosterone declined by over 60%, remaining unchanged with placebo. Symptom scores fell significantly in all 3 groups. Mean maximum flow rates fell slightly in placebo-treated patients but improved by 1.5 ml/s in the 10 mg group and by 3.3 ml/s in the 5 mg group. After 1 year's treatment, the reduction in symptom score and increase in flow rate were well maintained; the mean prostate volume was reduced by 14% and prostatic specific antigen declined by 28%. It was concluded that finasteride shows some efficacy in the treatment of BPH, with minimal toxicity, but 12 months of therapy or longer may be necessary to achieve maximal effect.

Aged↗
PubMed1991

Hormonal effects of a 5 alpha-reductase inhibitor (finasteride) on hormonal levels in normal men and in patients with benign prostatic hyperplasia.

Finasteride is a potent competitive 5 alpha-reductase inhibitor, active at a dose as low as 1 mg/day. After a single dose, the effects on 5 alpha-reductase last as long as 7 days. Both hepatic and target tissue 5 alpha-reductase are inhibited. Plasma testosterone and estradiol are unaffected and luteinizing hormone levels do not change. During chronic treatment with finasteride 5 mg/day, the effects on 5 alpha-reductase are maintained. Since the only significant effect of chronic finasteride therapy appears to be 5 alpha-reductase inhibition, and testosterone or estradiol levels are not affected, neither libido nor potency is lost. Testosterone is the active androgen at the muscular level; therefore, muscular catabolism is not expected.

5-alpha Reductase Inhibitors↗
PubMed1993

Long-term urodynamic effects of finasteride in benign prostatic hyperplasia: a pilot study.

A group of 69 men with bladder outflow obstruction due to benign prostatic hyperplasia (BPH) were treated in a double-blind placebo-controlled study with finasteride (Proscar), a 5 alpha-reductase inhibitor, 5 mg or 10 mg/day, or an identical placebo for 3 months; subsequently, 20 patients received finasteride 5 mg/day in an open extension study. Ten of these patients have now completed 3 years of therapy and have been reevaluated with pressure/flow urodynamics. In finasteride-treated patients dihydrotestosterone (DHT) declined by over 60%, remaining unchanged with placebo. Symptom scores fell in both groups of patients, maximum flow rate values decreased on placebo but improved by a mean of 1.5 ml/s in the 10-mg group and 3.3 ml/s in the 5-mg group. After 1 year of therapy, the reduction in symptom score was well maintained and the flow rate had increased by a mean of 2.7 ml/s; the mean prostate volume was reduced by 14% and prostate-specific antigen (PSA) had declined by 28%. In the 10 patients treated for 3 years who consented to further urodynamic study, the maximum urinary flow rate had improved from a mean baseline value of 8.7 ml/s to a mean of 13.8 ml/s, while maximum subtracted voiding pressure had decreased from a mean baseline value of 72 cm H2O to an unobstructed mean value of 44 cm H2O. Side effects were minimal and reversible on stopping the medication.(ABSTRACT TRUNCATED AT 250 WORDS)

5-alpha Reductase Inhibitors↗
PubMed1992

Effect of finasteride, a 5 alpha-reductase inhibitor, on serum gonadotropins in normal men.

Testosterone exerts negative feedback control on gonadotropin secretion either directly, after aromatization to estradiol, or after 5 alpha-reduction to dihydrotestosterone (DHT). Conflicting data exist as to the role of DHT in the modulation of this negative feedback. To determine whether suppression of endogenous DHT alters gonadotropin secretion, we gave the selective 5 alpha-reductase inhibitor finasteride (5 mg daily), or placebo, to 20 healthy men for 28 days. Basal and GnRH-stimulated LH, bioactive LH, FSH, testosterone, and DHT levels were measured before and after 14 and 28 days of treatment. Basal DHT fell from 1.1 +/- 0.2 to 0.15 +/- 0.04 nmol/L after 28 days of finasteride treatment. A significant rise in baseline testosterone from 17.6 +/- 2.0 to 18.3 +/- 2.3 nmol/L was seen at 14 days (P = 0.046), but not at 28 days. No significant changes were seen in either basal or GnRH-stimulated gonadotropin levels on any day. We conclude that suppression of serum DHT levels with 5 mg finasteride daily in healthy young men has no discernible effect on serum gonadotropin levels.

Adult↗
PubMed1994

The effects of finasteride (Proscar) on hair growth, hair cycle stage, and serum testosterone and dihydrotestosterone in adult male and female stumptail macaques (Macaca arctoides).

Finasteride, a 5 alpha-reductase inhibitor, was administered orally (1 mg/kg.day) for 6 months to six male and five female stumptail macaques. Vehicle was given to five male and five female animals over the same period of time. Hair weights in a defined 1-in.2 area of frontal scalp were measured periodically every 1-2 months, and serum was collected for measurement of testosterone and dihydrotestosterone. In addition, scalp biopsies were taken before and 6 months after treatment to evaluate the micromorphometry of hair follicles. Results showed that both male and female serum dihydrotestosterone levels were significantly reduced (60-70%) by finasteride treatment. Both males and females showed statistically significant increases in mean hair weight over the treatment period compared to controls (P = 0.034). In addition, there was a statistically significant increase in mean follicle length (measured histologically in scalp biopsies) compared to baseline in the finasteride-treated animals (P = 0.028). These data show that an inhibition of 5 alpha-reductase in the stumptail macaque can reverse the balding seen with age in both the male and female animals.

Animals↗
PubMed2000

Comparison of spironolactone, flutamide, and finasteride efficacy in the treatment of hirsutism: a randomized, double blind, placebo-controlled trial.

To compare objectively the efficacies of spironolactone (100 mg/day), flutamide (250 mg/day), and finasteride (5 mg/day) in the treatment of hirsutism, 40 hirsute women were randomly assigned to double blind treatments with 1 of these 3 drugs or placebo for 6 months. Before and at the end of treatment, hirsutism was quantitatively measured in each subject by determination, by computer-assisted light microscopy, of the largest diameter of 5 hairs plucked from the linea alba. These measurements were averaged to produce a mean hair shaft diameter. For each subject, baseline and posttreatment assessments were carried out at the same time by an investigator blinded to both time and type of therapy. In addition, a semi-quantitative clinical evaluation was carried out by a modification of the Ferriman-Gallwey (F-G) scoring method, performed by a single investigator. At baseline the 4 groups of women had similar hair diameters and F-G scores. After 6 months of therapy all groups of subjects given active drugs showed reductions of their hair diameters, without statistically significant differences among groups (mean change +/- SEM, -11.7+/-5.6%, -18.0+/-6.1%, and -12.6+/-6.7%, respectively, in the spironolactone, flutamide, and finasteride groups). F-G scores were also significantly reduced in women receiving antiandrogen drugs, again without differences among groups (mean change, -41.0+/-5.5%, -38.9+/-7.2%, and -31.6+/-3.7%, respectively). No significant changes from baseline values were recorded by either hair diameter (-1.4+/-5.2%) or F-G score (+5.4+/-3.7%) assessment in the placebo group. In conclusion, spironolactone, flutamide, and finasteride are all effective in the treatment of hirsutism. After a 6-month course of therapy, the clinical efficacies of these drugs, at least at the doses used, are similar.

Adult↗
PubMed2004

Finasteride in the treatment of alopecia.

Finasteride is a 5alpha-reductase inhibitor approved for the treatment of male pattern hair loss. Originally approved for the treatment of benign prostatic hypertrophy in 1992, its approval was expanded in 1997 to include the treatment of androgenetic alopecia (AGA) in men at a dose of 1 mg/day. Finasteride inhibits 5alpha-reductase, thereby prohibiting the conversion of testosterone to dihydrotestosterone (DHT), which is implicated in the development of hairless in some men. Reduction in DHT results in a significant improvement in subjective and objective assessments of hair growth and density. Finasteride is well-tolerated with a favourable adverse event history. The most common adverse events include reduced libido, decreased ejaculate volume and gynaecomastia.

Alopecia↗
PubMed2004

A comparison between spironolactone and spironolactone plus finasteride in the treatment of hirsutism.

OBJECTIVE: To compare the clinical efficacy and safety of the combination of spironolactone (100 mg/day) plus finasteride (5 mg/day) and spironolactone (100 mg/day) alone in the treatment of hirsutism. PATIENTS AND MEASUREMENTS: Sixty-five hirsute women were randomly assigned to one of these two treatment groups. Hirsutism score was measured according to the modified Ferriman-Gallwey scoring system. Baseline and post-treatment assessments were carried out in each subject by an investigator blinded to the therapy. Both groups had similar demographic properties at baseline. The serum levels of total and free testosterone, dehydroepiandrosterone sulphate and sex hormone-binding globulin were measured at the beginning and after 1 year of therapy. Blood chemistry and side-effects were evaluated during the study. Hirsutism scores were decreased significantly in both groups at the end of the year. RESULTS: The mean percentage change in hirsutism scores from baseline in the spironolactone plus finasteride-treated group (51.3%) was significantly (P<0.005) higher than in the group treated with spironolactone alone (36.6%). Patients from both treatment groups experienced similar side-effects. CONCLUSIONS: We have concluded that a combination of spironolactone plus finasteride is a safe and effective therapy in the treatment of hirsutism.

Adult↗
PubMed1997

Treatment of hirsutism by finasteride and flutamide in women with polycystic ovary syndrome.

Forty-four hirsute patients with polycystic ovary syndrome were randomly treated with finasteride (5 mg daily) or flutamide (250 mg twice daily) for 6 consecutive months. Hirsutism was evaluated before and after therapy with the Ferriman-Gallwey score and with measurement of hair diameter (micron). The hairs were taken from four different body areas: the face, abdomen, thighs and forearm. The measurement was carried out with a micrometer applied to the optical microscope. Mean plasma concentrations of luteinizing hormone, follicle-stimulating hormone, 17 alpha-hydroxyprogesterone, androstenedione, testosterone, free testosterone, dehydroepiandrosterone sulfate, insulin, and sex hormone binding globulin were determined before and after therapy. Hematochemical examinations and side-effects were controlled after the treatment. After 6-months' therapy, both antiandrogens significantly reduced the Ferriman-Gallwey score and hair diameter in all the body areas. Finasteride reduced the Ferriman-Gallwey score by 25% and hair diameter by 16-25%; flutamide reduced the score by 20% and hair diameter by 15.3-22%. Abdominal hairs were more sensitive to both drugs. Flutamide induced a significant drop in total testosterone and dehydroepiandrosterone sulfate. No important side-effect or change in the hematochemical parameters was observed. Our data demonstrate that finasteride and flutamide are effective in the treatment of hirsutism in patients with polycystic ovary syndrome.

17-alpha-Hydroxyprogesterone↗