Long-term therapy of signs of androgenisation with a low-dosed antiandrogen-oestrogen combination.

Abstract

Researchers from Berlin Germany analyzed data on 1161 women with mild to severe signs of androgenization and were part of an uncontrolled open multicenter phase III clinical trial of the combined oral contraceptive Diane 35 (2 mg cyproterone acetate and 0.35 mg ethinyl estradiol). Diane 35 had already shown signs of healing/improving acne by cycle 3. Specifically healing/improving of acne on the face chest and back had occurred in 37.8% 34.5% and 38.5% of the cases respectively. Diane 35 was more effective earlier in 25-year old women (by cycle 3 42% vs. 30.4%) but by cycle 36 both groups of women experienced equal improvement. Seborrhea symptoms had almost completely disappeared by cycle 36 (greasy skin 100%; greasy hair 100%; scaling 95.9%). Diane 35 induced healing of hirsutism later than it was able to with seborrhea and acne. For example healing occurred in 17% with mild facial hirsutism by cycle 3. For women with severe facial hirsutism however Diane 35 completely eliminated hirsutism in 50% of cases and improved the condition in the remaining women by cycle 24. Only 2 pregnancies occurred (Pearl Index 0.1/100 woman years) and they were due to patient error. Diane 35 was able to control menstrual cycles in women with a history of menstrual disorders. In fact intermenstrual bleeding only occurred in 4.4% of cycles and the incidence was highest in the beginning (13%) then tapered off to 0.5% by cycle 36. The amenorrhea rate was only 0.3% of cycles. Diane 35 almost completely eliminated severe dysmenorrhea and strongly decreased mild dysmenorrhea (1.1% vs. 0.03% and 15.2% vs. 8.2% respectively). Diane 35 did not alter body weight in 90.1% of women after cycle 3 or in 81.8% after cycle 36. It had a positive effect on blood pressures. Only 11.7% of the women withdrew form the study due to adverse reactions. The leading side effects at cycle 36 were chloasma (6.9%) breast tension (5.6%) and nonmigraine headache (5.1%). Diane 35 was able to relatively quickly treat signs of androgenization especially acne.