Fertility & Sterility March 2001
Comparison of Diane 35 and
Diane 35 plus finasteride in the treatment of hirsutism.
Sahin Y, Dilber S, Keleştimur F
Department of Obstetrics and Gynecology, Kayseri, Turkey
Objective: To compare the clinical efficacy and safety
of the combination of Diane 35 (2 mg of cyproterone acetate,
and 35 mg of ethinyl estradiol) plus finasteride (5 mg), and
Diane 35 alone in the treatment of hirsutism.
Design: Prospective randomized clinical study.Setting:
Outpatients in Erciyes University Medical School.
Patient(s): Forty women with hirsutism were selected.Intervention(s):
For 1 year, group 1 patients (n = 20) were treated with Diane
35 alone (2 mg of cyproterone acetate and 35 mg of ethinyl
estradiol) daily on days 5 to 25 of the menstrual cycle and
group 2 patients (n = 20) with Diane 35 plus finasteride (5
mg daily).Main Outcome Measure(s): Hirsutism was graded at
6-month intervals using the Ferriman-Gallwey method. The basal
hormone levels of total and free testosterone (T), androstenedione,
DHEAS, and sex-hormone-binding globulin (SHBG) were measured
by radioimmunoassay before the study. Total T, free T, SHBG,
and DHEAS were also measured at 6-month intervals for 1 year.
Multiscreen blood chemistry and side effects were evaluated
during the treatment.
Result(s): Thirty-four patients completed the 12-month
study period. A significant decrease in the hirsutism score
as compared to baseline was observed after 12 months with
both Diane 35 treatment (mean +/- SD, 15.62 +/- 4.89 vs. 9.75
+/- 3.97) and Diane 35 plus finasteride treatment (16.27 +/-
6.90 vs. 8.38 +/- 4.44). The percentage decreases in the hirsutism
score (mean percent +/- SD) were 30.26 +/- 14.56 vs. 34.70
+/- 11.60 at 6 months, 38.09 +/- 11.46 vs. 48.14 +/- 14.27
at 12 months in the Diane 35 and the Diane 35 plus finasteride
groups, respectively. The percentage reduction in the hirsutism
score in the Diane 35 plus finasteride group at 12 months
was greater than in the Diane 35 group (P <.05).
Conclusion(s): The percentage decrease in the hirsutism
score at 12 months was higher in the Diane 35 plus finasteride
group than in the Diane 35 group. We believe that Diane 35
plus finasteride is an effective and safe combination for
the treatment of hirsutism.