Time Androgens and Sexual Hormone Binding Globulin (SHBG) Take to Return to Baseline Levels Following Discontinuation of Oral Contraceptives Pills (OCP), in Women With Polycystic Ovary Syndrome (PCOS), A Prospective Study

Abstract

To determine the time that it takes for androgens and SHBG in women with PCOS to return to their pretreatment levels, following discontinuation of therapy with an OCP containing drospirenone and ethinyl-estradiol. Prospective descriptive clinical trial. Eight (8) subjects with diagnosis of PCOS were assigned to receive a combination OCP containing drospirenone 3 mg and ethinyl-estradiol 30 μg for 12 weeks. After this treatment period, subjects discontinued OCP and were followed up during 8 weeks. All patients had, at least, 12 weeks without hormonal treatment and normal levels of thyroid-stimulating hormone, and prolactin before entering the study protocol. The diagnosis of PCOS was established by the exclusion of other conditions that can cause chronic anovulation with associated hyperandrogenism: 21-OH-deficient-non classic adrenal hyperplasia, ovarian-adrenal tumors, and Cushing’s syndrome. Serum samples were collected prior to and at week 12 of treatment, and also 4 and 8 weeks after discontinuation of OCP. Samples were frozen at -20 °C. We measured total (TT) and free testosterone (FT), dehydroepiandrosterone sulfate (DHEAS), and SHBG levels, by ELISA and RIA. Statistical analysis was performed using KwikStat-4 Statistical Data Analysis Program (TexaSoft, Cedar Hill, TX). A total of 7 PCOS subjects completed the study. Mean age was 26.29 years. Mean body mass index (BMI) at basal conditions and end of treatment period were 24.35 and 24.29 kg/m2, respectively (p = 0.86). Ferriman-Gallwey score decreased during treatment period, but change did not reach significance (mean baseline and post-treatment values were 4.14 and 3.86; p = 0.36). Mean initial and after 12 weeks of treatment levels for TT, FT, DHEAS, and SHBG were 4.14 nmol/L (119 ng/dL) and 1.9 nmol/L (54.86 ng/dL); 0.01 nmol/L (0.28 ng/dL) and 0.004 nmol/L (0.11 ng/dL); 4.4 μmol/L (164 μg/dL) and 2.84 μmol/L (105 μg/dL); 59 nmol/L and 311 nmol/L, respectively. Following discontinuation of OCP androgen levels increased progressively, at 4 and 8 weeks. Levels of TT (3.72 nmol/L = 107.3 ng/dL) and DHEAS (3.81 μmol/L = 140 μg/dL) at week 4 were not significantly different from those measured at baseline. Alternatively, FT (0.008 nmol/L = 0.22 ng/dL) and SHBG (54.4 nmol/L) returned to levels not significantly different from baseline values, only at week 8 post discontinuation of OCP. In this population of PCOS women, discontinuation of an OCP containing drospirenone 3 mg and ethinyl estradiol 30 μg was followed by return of TT and DHEAS to baseline levels in 4 weeks. On the other hand, levels of FT and SHBG returned to basal values only 8 weeks after discontinuation of OCP. These observations are pertinent when measuring androgens and SHBG in subjects suspected of having PCOS, who are currently taking OCP.