Testosterone addition during menopausal hormone therapy: effects on mammographic breast density.
OBJECTIVE
To study the effect on mammographic breast density of testosterone addition during combined estrogen/progestogen therapy in postmenopausal women.


METHODS
A prospective, randomized, double-blind, placebo-controlled trial. A total of 99 women were given 2 mg 17beta-estradiol and 1 mg norethisterone acetate in combination with either a testosterone patch (300 mug/24 h) or a placebo patch. Mammographic breast density at baseline and after 6 months was assessed by visual classification scales and by digitized quantification. A standardized questionnaire was used to quantify subjective breast symptoms.


RESULTS
Visual classifications showed an increase in mammographic density in 18-30% of the women, with no significant differences between the treatment groups. The mean increase of the area of dense breast during treatment according to digitized assessment was 7.4% in the placebo group and 5.4% in the testosterone group. Breast symptoms showed a positive association with the increase in density (r(s) = 0.34; p < 0.01). Symptoms were most pronounced at 2 months of treatment. Density, both at baseline (r(s) = -0.35; p < 0.01) and change during treatment (r(s) = -0.28; p < 0.01) showed a negative association with free testosterone levels.


CONCLUSIONS
The addition of testosterone does not appear to influence mammographic breast density in women concurrently treated with a common oral estrogen/progestogen regimen for a period of 6 months.
Hofling
M
M
Department of Obstetrics and Gynecology, Karolinska Institutet and University Hospital, Stockholm, Sweden.
Lundström
E
E
Azavedo
E
E
Svane
G
G
Hirschberg
A Linden
AL
von Schoultz
B
B
D000368:Aged; D000728:Androgens / Q000008:administration & dosage*; D001940:Breast / Q000187:drug effects*; D003280:Contraceptives, Oral, Synthetic / Q000008:administration & dosage; D013196:Dihydrotestosterone / Q000097:blood; D004311:Double-Blind Method; D004958:Estradiol / Q000008:administration & dosage / Q000097:blood; D005260:Female; D020249:Hormone Replacement Therapy; D006801:Humans; D008327:Mammography; D008875:Middle Aged; D009640:Norethindrone / Q000008:administration & dosage / Q000031:analogs & derivatives; D000077563:Norethindrone Acetate; D011446:Prospective Studies; D013739:Testosterone / Q000008:administration & dosage* / Q000097:blood
D000728:Androgens; D003280:Contraceptives, Oral, Synthetic; D013196:Dihydrotestosterone; D013739:Testosterone; D004958:Estradiol; D000077563:Norethindrone Acetate; D009640:Norethindrone