Abstract
ObjectiveThis study describes ovarian activity suppression of a 21/7-active low-dose combined oral contraceptive (COC) regimen that included only ethinyl estradiol (EE) during the traditional hormone-free interval (HFI) and two commercially available 28-day regimens, a 24/4 and a 21/7 regimen. Study designThe randomized, open-label, parallel-group descriptive study was conducted at two US sites. Healthy, reproductive-aged women (n=146) were randomized to one of three groups for three consecutive 28-day cycles, as follows: treatment 1 (n=39 completed): 21/7-active COC [21days of 150 mcg desogestrel (DSG)/20 mcg EE, followed by 7days of 10 mcg EE (DSG/EE+7days EE)], treatment 2 (n=39 completed): 24days of 3mg drospirenone (DRSP)/20 mcg EE, followed by 4 placebo (PBO)-pill days (DRSP/EE+4days PBO) and treatment 3 (n=42 completed): 21days of 100 mcg levonorgestrel (LNG)/20 mcg EE, followed by 7 PBO-pill days (LNG/EE+7days PBO). The primary outcome was ovarian activity suppression assessed by transvaginal ultrasound and serum hormone concentrations and classified using the Hoogland and Skouby (H/S) method. ResultsOvarian activity rate (H/S grade 4 or 5) was low for all three treatments: 0% [95% confidence interval (CI) 0–2.8] for DSG/EE+7days EE, 1% (95% CI 0.2–5.2) for DRSP/EE+4days PBO and 1% (95% CI 0–3.9) for LNG/EE+7days PBO. All three treatments showed similar suppression of serum progesterone, 17β-estradiol, follicle-stimulating hormone and luteinizing hormone levels. ConclusionsThe 21/7-active low-dose COC regimen (DSG/EE+7days EE) showed ovarian activity suppression that was similar to the 24/4 (DRSP/EE+4days PBO) and 21/7 (LNG/EE+7days PBO) regimens. ImplicationsThe 21/7-active low-dose COC regimen (DSG/EE+7days EE) that included only EE during the traditional HFI showed suppression of ovarian follicular activity that was similar to the 24/4 (DRSP/EE+4days PBO) and the 21/7 (LNG/EE+7days PBO) comparator regimens.
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