Results of an Open One‐Year Study with Diane‐35 in Women with Polycystic Ovarian Syndrome

Abstract

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.

Drospirenone for the Treatment of Hirsute Women with Polycystic Ovary Syndrome: A Clinical, Endocrinological, Metabolic Pilot Study

“…These effects are probably related to the specific chemical properties of DRSP; unlike 19-nortestosterone derivatives (norethindrone and levonorgestrel), DRSP does not counteract the stimulatory effect of EE on SHBG synthesis and does not prevent androgen binding with it (5,29). Furthermore, the magnitude of increase in plasma SHBG concentrations obtained in our PCOS patients (384%) is greater than those reported in literature after administration of 17␣-hydroxyprogesterone derivatives, such as CPA (2,3). These actions may account for the marked and lasting amelioration of F-G scores obtained in our patients.…”

“…The suppression of gonadotropin secretion and androgen production from ovaries and adrenal glands, the stimulation of SHBG production, along with the inhibition of peripheral androgen receptors are thought to account for the ability of these drugs to ameliorate hirsutism, acne, and alopecia in hyperandrogenic women with PCOS (2,3).…”

Comparative study of the therapeutic effects of oral contraceptive pills containing desogestrel, cyproterone acetate, and drospirenone in patients with polycystic ovary syndrome

“…Animal studies have shown that a daily dose of 2 mg of cyproterone acetate does not have a noticeable antiandrogenic effect (28). Therefore, the increase of SHBG by ethinyl E 2 may be an important factor.…”

The use of cyproterone acetate/ethinyl estradiol in hyperandrogenic skin symptoms – a review

“…Kahraman et al [46] describe more prominent changes in specific body areas, for example, the abdomen. In an openlabel study, Golland and Elstein [50] reported a healing/ improvement rate of 54.6% (reduction in mean F-G score from 14.3 to 5.7) at 12 months with CPA/EE in 22 women with severe facial hirsutism. Seven women experienced complete resolution of symptoms and a further six women experienced significant symptom improvement with CPA/EE after 12 months.…”

“…For example, when combined with antibiotics (tetracycline) in the treatment of acne, or with antiandrogens (finasteride or spironolactone) in the treatment of hirsutism, the potential for enhanced efficacy was suggested [31,36,37,55]. Studies where CPA/EE was added to gonadotropin releasing hormone agonist (GnRHa) to evaluate potential for amplification of treatment response in hyperandrogenic symptoms of PCOS described significant improvement in hirsutism symptoms overall (reductions in hirsutism score were between 24% and 47.4%) but no significant difference between the two groups [50,52,56]. Sequential use of CPA/EE with rosiglitazone did not generate any greater symptom improvement than use of CPA/EE alone in women with PCOS [49].…”