Chabbert-Buffet Nathalie, Chassard Didier, Ochsenbein Edith, Thomas Jean-Louis, Christin-Maitre Sophie
Obstetrics and Gynaecology Unit, Hôpital Tenon AP-HP, and ER-9, UPMC Université Paris 06, Paris, France.
Eur J Contracept Reprod Health Care. 2011 Apr;16(2):76-84. doi: 10.3109/13625187.2011.554923. Epub 2011 Feb 21.
To explore the optimal dose of the progestogen, nomegestrol acetate (NOMAC), required in a monophasic oral contraceptive, in combination with 1.5 mg 17β-oestradiol (E(2)), to inhibit ovulation.
A double-blind, randomised study assessing 41 normally cycling women (aged 18-35 years) over two screening cycles, one control cycle and one consecutive treatment cycle; 38 women completed the treatment period. Subjects received 0.625 mg NOMAC/1.5 mg E(2) (n = 9), 1.25 mg NOMAC/1.5 mg E(2) (n = 10), 2.5 mg NOMAC/1.5 mg E(2) (n = 10) or 2.5 mg NOMAC alone (n = 9) for 21 days.
During the treatment cycle, ovulation was suppressed in all treatment groups. The lowest plasma E(2) levels were observed with 2.5 mg NOMAC given alone. Addition of 1.5 mg E(2) to 2.5 mg NOMAC resulted in statistically significant increases in E(2) levels and decreases in mean follicle-stimulating hormone and luteinising hormone levels. In the three NOMAC/E(2) combination groups, a statistically significant inverse correlation was found between E(2) plasma levels and NOMAC dose.
The dose of 2.5 mg NOMAC was confirmed to be optimal to inhibit both ovulation and follicular maturation. The antigonadotropic effect of 2.5 mg NOMAC was reinforced when combined with 1.5 mg E(2).
探讨单相口服避孕药中与1.5毫克17β-雌二醇（E₂）联合使用时，醋酸诺美孕酮（NOMAC）抑制排卵所需的最佳剂量。
一项双盲、随机研究，对41名月经周期正常的女性（年龄18 - 35岁）进行两个筛查周期、一个对照周期和一个连续治疗周期的评估；38名女性完成了治疗期。受试者接受0.625毫克NOMAC/1.5毫克E₂（n = 9）、1.25毫克NOMAC/1.5毫克E₂（n = 10）、2.5毫克NOMAC/1.5毫克E₂（n = 10）或仅2.5毫克NOMAC（n = 9），持续21天。
在治疗周期中，所有治疗组的排卵均受到抑制。单独使用2.5毫克NOMAC时观察到最低的血浆E₂水平。在2.5毫克NOMAC中添加1.5毫克E₂导致E₂水平有统计学意义的升高，同时促卵泡生成素和促黄体生成素的平均水平降低。在三个NOMAC/E₂联合组中，血浆E₂水平与NOMAC剂量之间存在统计学意义的负相关。
2.5毫克NOMAC的剂量被证实是抑制排卵和卵泡成熟的最佳剂量。2.5毫克NOMAC与1.5毫克E₂联合使用时，其抗促性腺激素作用增强。
