To evaluate the effects of
Diane-35 on androgenized oligomenorrheic women with
polycystic ovarian syndrome, 32 women with PCOS were recruited to an open study of one-year duration. The effects of
Diane-35 on signs of
androgenization and on morphological and hormonal parameters were assessed in the pre- and posttreatment cycles and in the 3rd, 6th, 9th, and 12th treatment cycles. Twenty-two women completed the 12-month study period, five withdrew due to adverse events, two were lost to follow-up, and three stopped early because of a lack of efficacy. Ultrasound demonstrated significant reductions in ovarian volume, stromal density, and follicle number and size. Serum concentrations of LH, FSH,
testosterone,
androstenedione, and
dehydroepiandrosterone sulfate decreased, and serum SHBG increased significantly. Mean Ferriman-Gallwey
hirsutism scores declined from 14.3 before treatment to 5.7 at completion of
therapy. Severe facial
hirsutism, present in 23 (71.9%) of 32 women, disappeared in 6 women and improved in 6 women--a healing/improvement rate of 54.6% of 22 women who completed the study. Cycle control was good,
amenorrhea occurred in 5 (1.6%) of 322 treatment cycles, while 94.8% of withdrawal bleeds were normal or scanty. Intermenstrual
spotting occurred in 7.1% and break-through
bleeding in 4.4% of all treatment cycles. The incidence of adverse events was similar to that of other
gestagen-
estrogen combinations. The results of the study demonstrate that
Diane-35 provides an effective
therapy for androgenized oligomenorrheic women with PCOS wishing simultaneous
contraceptive protection.