Comparison of Diane 35 and Diane 35 plus finasteride in the treatment of hirsutism.
OBJECTIVE
To compare the clinical efficacy of an original combined therapy with cyproterone acetate, 2 mg, and ethinylestradiol, 35 microgram (Diane 35), plus finasteride (5 mg) for 2 weeks per month with that of Diane 35 alone in hirsute women.


METHODS
Prospective randomized, single-blinded study.


METHODS
Outpatients in an academic research environment.


METHODS
Fifty women with idiopathic hirsutism (IH) or the polycystic ovary syndrome (PCOS).


METHODS
Group 1 (n = 25) received Diane 35 alone and group 2 (n = 25) received Diane 35 plus finasteride. The latter drug was administered using a new therapeutic scheme: 14 consecutive days for each therapeutic cycle.


METHODS
Hormonal evaluation was done before beginning treatment and after 3 and 6 months of therapy. Hirsutism was graded at 3-month intervals.


RESULTS
The combination of Diane 35 plus finasteride for 14 days significantly decreased the hirsutism score after 3 months of therapy, while Diane 35 alone induced this effect after 6 months.


CONCLUSIONS
Finasteride in combination with Diane 35 for 14 days is effective, well accepted, and safe in hirsute patients, as the amount of antiandrogenic drugs administered is much lower than that in conventional treatment.
Tartagni
M
M
Università di Bari, Policlinico di Bari, Bari, Italy. tartagni@libero.it
Schonauer
L M
LM
De Salvia
M A
MA
Cicinelli
E
E
De Pergola
G
G
D'Addario
V
V
D000293:Adolescent; D000328:Adult; D000726:Androgen Antagonists / Q000009:adverse effects / Q000627:therapeutic use*; D000728:Androgens / Q000097:blood; D017373:Cyproterone Acetate / Q000009:adverse effects / Q000627:therapeutic use*; D004338:Drug Combinations; D004359:Drug Therapy, Combination; D004997:Ethinyl Estradiol / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D018120:Finasteride / Q000009:adverse effects / Q000627:therapeutic use*; D006628:Hirsutism / Q000097:blood / Q000188:drug therapy*; D006801:Humans; D011085:Polycystic Ovary Syndrome / Q000097:blood / Q000188:drug therapy; D011446:Prospective Studies; D016037:Single-Blind Method; D016896:Treatment Outcome
D000726:Androgen Antagonists; D000728:Androgens; D004338:Drug Combinations; D004997:Ethinyl Estradiol; D017373:Cyproterone Acetate; D018120:Finasteride; C032640:Cyproterone acetate, ethinyl estradiol drug combination