In a study of finasteride 1 mg daily in healthy men, a median decrease in ejaculate volume of 0.3 mL (-11%) compared with 0.2 mL (-8%) for placebo was observed after 48 weeks of treatment. Two other studies showed that finasteride at 5 times the dosage of finasteride (5 mg daily) produced significant median decreases of approximately 0.5 mL (-25%) compared to placebo in ejaculate volume, but this was reversible after discontinuation of treatment. In the clinical studies with finasteride, the incidences for breast tenderness and enlargement, hypersensitivity reactions, and testicular pain in finasteride-treated patients were not different from those in patients treated with placebo .
Controlled Clinical Trials and Long-Term Open Extension Studies for Finasteride 5 mg and AVODART (dutasteride) in the Treatment of Benign Prostatic Hyperplasia
In the Finasteride 5 mg Long-Term Efficacy and Safety Study, a 4-year controlled clinical study, 3040 patients between the ages of 45 and 78 with symptomatic BPH and an enlarged prostate were evaluated for safety over a period of 4 years (1524 on finasteride 5 mg/day and 1516 on placebo). 3.7% (57 patients) treated with finasteride 5 mg and 2.1% (32 patients) treated with placebo discontinued therapy as a result of adverse reactions related to sexual function, which are the most frequently reported adverse reactions.
Table 2presents the only clinical adverse reactions considered possibly, probably or definitely drug related by the investigator, for which the incidence on finasteride 5 mg was ≥1% and greater than placebo over the 4 years of the study. In years 2 to 4 of the study, there was no significant difference between treatment groups in the incidences of impotence, decreased libido and ejaculation disorder.
The adverse experience profiles in the 1-year, placebo-controlled, Phase III BPH studies and the 5-year open extensions with finasteride 5 mg and Finasteride 5 mg Long-Term Efficacy and Safety Study were similar.
There is no evidence of increased sexual adverse experiences with increased duration of treatment with finasteride 5 mg. New reports of drug-related sexual adverse experiences decreased with duration of therapy.
During the 4- to 6-year placebo- and comparator-controlled Medical Therapy of Prostatic Symptoms (MTOPS) study that enrolled 3047 men, there were 4 cases of breast cancer in men treated with finasteride 5 mg but no cases in men not treated with finasteride 5 mg. During the 4-year placebo-controlled Finasteride 5 mg Long-Term Efficacy and Safety Study that enrolled 3040 men, there were 2 cases of breast cancer in placebo-treated men, but no cases were reported in men treated with finasteride 5 mg.
During the 7-year placebo-controlled Prostate Cancer Prevention Trial (PCPT) that enrolled 18,882 men, there was 1 case of breast cancer in men treated with finasteride 5 mg, and 1 case of breast cancer in men treated with placebo. The relationship between long-term use of finasteride and male breast neoplasia is currently unknown.
The PCPT trial was a 7-year randomized, double-blind, placebo-controlled trial that enrolled 18,882 healthy men ≥55 years of age with a normal digital rectal examination and a PSA ≤3.0 ng/mL. Men received either finasteride 5 mg or placebo daily. Patients were evaluated annually with PSA and digital rectal exams. Biopsies were performed for elevated PSA, an abnormal digital rectal exam, or the end of study. The incidence of Gleason score 8 to 10 prostate cancer was higher in men treated with finasteride (1.8%) than in those treated with placebo (1.1%). In a 4-year placebo-controlled clinical trial with another 5α-reductase inhibitor [AVODART (dutasteride)], similar results for Gleason score 8 to 10 prostate cancer were observed (1% dutasteride vs 0.5% placebo). The clinical significance of these findings with respect to use of finasteride 1 mg by men is unknown.
No clinical benefit has been demonstrated in patients with prostate cancer treated with finasteride 5 mg. Finasteride 5 mg is not approved to reduce the risk of developing prostate cancer.
Sexual Function Questionnaire
A sexual function questionnaire was self-administered by patients participating in the two vertex baldness trials to detect more subtle changes in sexual function. At Month 12, statistically significant differences in favor of placebo were found in 3 of 4 domains (sexual interest, erections, and perception of sexual problems). However, no significant difference was seen in the question on overall satisfaction with sex life.
In one of the two vertex baldness studies, patients were questioned on non-scalp body hair growth. Finasteride did not appear to affect non-scalp body hair.