Department of Obstetrics and Gynecology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.
Sci Rep. 2020 May 29;10(1):8782. doi: 10.1038/s41598-020-65642-5.
To determine the effectiveness of quick starting combined oral contraception (COC) contain 2.5 mg nomegestrol acetate and 1.5 mg estradiol (NOMAC/E2) comparing with 0.075 mg gestodene and 0.02 mg ethinyl estradiol (GS/EE) on ovarian ovulation inhibition rate, we conducted a non-inferiority randomized controlled trial involving 69 healthy female volunteers aged 18-40 years who had normal menstrual history and were randomized at a 2:1 ratio to take one pack of COC containing either NOMAC/E2 (study group) or GS/EE (control group) starting on menstrual cycle Day7-9. The ovarian activity was assessed by using Hoogland and Skouby grading. Forty-six and 23 participants were randomized to NOMAC/E2 and GS/EE groups, respectively. Baseline characteristics were similar between groups. No significant difference was observed between the study and control groups for ovulation inhibition rate (93.4% vs. 95.6%, risk difference: -2.2%, 95% CI: -13.1, 8.8), ovarian quiescence rate (91.2% vs. 91.2%, P = 1.000), persistent cyst rate (2.2% vs. 4.4%, P = 1.000), and ovulation rate (6.6% vs. 4.4%, P = 1.000). Quick starting COC during day7-9 of menstrual cycle can inhibit ovulation for more than 90%. The quick starting NOMAC/E2 is non-inferior to GS/EE for preventing ovulation and suppressing follicular growth.
为了确定起始迅速的复方口服避孕药（COC）中 2.5 毫克醋酸诺美孕酮和 1.5 毫克雌二醇（NOMAC/E2）相对于 0.075 毫克屈螺酮和 0.02 毫克炔雌醇（GS/EE）对卵巢排卵抑制率的有效性，我们进行了一项非劣效性随机对照试验，纳入了 69 名年龄在 18-40 岁之间、月经史正常的健康女性志愿者，她们以 2:1 的比例随机分为 NOMAC/E2 组（研究组）或 GS/EE 组（对照组），在月经周期的第 7-9 天开始服用 COC 一片。使用 Hoogland 和 Skouby 分级评估卵巢活动。46 名和 23 名参与者分别被随机分配到 NOMAC/E2 组和 GS/EE 组。两组的基线特征相似。研究组和对照组的排卵抑制率（93.4%对 95.6%，风险差：-2.2%，95%CI：-13.1，8.8）、卵巢静止率（91.2%对 91.2%，P=1.000）、持续囊肿率（2.2%对 4.4%，P=1.000）和排卵率（6.6%对 4.4%，P=1.000）无显著差异。在月经周期的第 7-9 天开始使用 COC 可以抑制排卵 90%以上。起始迅速的 NOMAC/E2 在预防排卵和抑制卵泡生长方面不劣于 GS/EE。
