Title
| Effects of finasteride (MK-906), a 5 alpha-reductase inhibitor, on
| circulating androgens in male volunteers.
| Author
| Gormley GJ; Stoner E; Rittmaster RS; Gregg H; Thompson DL; Lasseter
| KC; Vlasses PH; Stein EA
| Address
| Merck, Sharp, and Dohme Research Laboratories, Rahway, New Jersey
| 07065.
| Source
| J Clin Endocrinol Metab, 70: 4, 1990 Apr, 1136-41
| Abstract
| Finasteride, a 5 alpha-reductase inhibitor, was administered to normal
| male volunteers in a blinded placebo-controlled study at daily oral
| doses of 25, 50, and 100 mg for 11 days (part 1) and daily oral doses
| of 0.04, 0.12, 0.2, and 1.0 mg for 14 days (part 2). Results from part
| 1 showed a significant reduction in dihydrotestosterone (DHT) at all
| doses and a significant increase in both testosterone (T) and delta
| 4-androstenedione at the 50- and 100-mg doses. No change was seen in
| LH, FSH, cortisol, or estradiol levels. Serum lipids, including total
| cholesterol, low density lipoprotein, high density lipoprotein, and
| triglycerides were not affected by treatment. Results from part 2
| again showed significant reduction in DHT at all doses. DHT levels
| returned to pretreatment values within 14 days of discontinuing
| treatment. Significant increases in T were observed only in the 1.0 mg
| group and only during the first 8 days of treatment. The T/DHT ratio
| increased with all doses and returned to baseline when drug was
| discontinued. The DHT metabolites and androstanediol glucuronide and
| androsterone glucuronide were significantly reduced at all doses.
| There were no significant adverse experiences reported during part 1
| or 2. In conclusion, finasteride is well tolerated by normal
| volunteers and results in significant suppression of serum DHT at all
| doses tested.
| Unique Identifier
| 90203145
| Also presented at the 1995 American Association of Dermatology Meeting in
| New Orleans (February 5-8, 1995), were preliminary results from phase II
| dose-range-finding studies, designed to help determine the optimal dose of
| finasteride for use in male pattern baldness. A six-week trial measured
| concentrations of scalp-skin and serum DHT, using oral finasteride at doses
| of 0.01, 0.05, 0.2, 1 or 5 mg per day or placebo. Finasteride at doses of
| 0.01, 0.05, 0.2, 1 or 5 mg per day suppressed scalp-skin DHT. In men taking
| 0.05-5mg per day of oral finasteride, scalp-skin DHT was reduced between 56
| and 69 percent from baseline. In men taking placebo, scalp-skin DHT
| decreased by 13 percent. Other than the group taking 0.01 mg, no significant
| differences between the doses were seen; however, significant differences
| were seen between the groups that received finasteride (not including 0.01),
| and the group that received placebo. Effects on hair growth, were determined
| in a 6-month trial using doses of 0.01, 0.2, or 1 mg per day or placebo.
Erika
