Effect of oral contraceptives containing estradiol and nomegestrol acetate or ethinyl-estradiol and chlormadinone acetate on primary dysmenorrhea

Abstract

Objective: To study the three cycles effect on primary dysmenorrhea of the monophasic 24/4 estradiol/nomegestrol acetate (E2/NOMAC) and of the 21/7 ethinyl-estradiol/chlormadinone acetate (EE/CMA) oral contraceptive. The tolerability and the effect of both preparations on metabolism and health-related quality of life were also evaluated.

Design: Prospective observational cohort study.

Setting: Tertiary gynecologic center for pelvic pain.

Patients: Subjects with primary dysmenorrhea requiring an oral contraceptive, who spontaneously selected either E2/NOMAC (n = 20) or EE/CMA (n = 20).

Main outcome measures: Visual Analogue Scale (VAS) score for dysmenorrhea, Short Form-36 questionnaire for health-related quality of life, lipoproteins and days of menstrual bleeding (withdrawal bleeding during oral contraceptive).

Results: Mean age and body mass index (BMI) were similar between the two groups. The final analysis was performed on 34 women, 15 in E2/NOMAC and 19 in EE/CMA group. Compliance with treatment was significantly higher with EE/CMA (100%) than E2/NOMAC (75%) (p = 0.02). Both treatments significantly (p < 0.0001) reduced VAS of primary dysmenorrhea, similarly (E2/NOMAC by a mean of 74.7%, EE/CMA by a mean of 78.4%; p = 0.973). Only E2/NOMAC significantly increased SF-36 score (p = 0.001), both in physical (p = 0.001) and mental domains (p = 0.004). The mean number of days of menstrual bleeding was significantly reduced in E2/NOMAC group (from 4.86 ± 1.20 d to 2.64 ± 1.59 d, p = 0.0005 versus baseline, p = 0.007 versus EE/CMA group). BMI did not vary in either group. E2/NOMAC did not change lipoproteins and apoproteins while EE/CMA increased total cholesterol (p = 0.0114), HDL-cholesterol (p = 0.0008), triglycerides (p = 0.002), apoprotein-A1 (Apo-A1; p = 0.0006) and apopoprotein-B (Apo-B; p = 0.008), decreasing LDL/HDL ratio (p = 0.024).

Conclusions: Both oral contraceptives reduced similarly primary dysmenorrhea, with E2/NOMAC also reducing withdrawal bleedings and being neutral on lipid metabolism.

Chinese abstract

目的：研究服用单相24/4 雌二醇/醋酸诺美孕素（E2/NOMAC）与21/7 炔雌醇/醋酸氯地孕素（EE/CMA）口服避孕药三个周期对原发性痛经的治疗作用。且评估药物的耐药性及两种剂型对代谢和健康相关生活质量的影响。

设计：前瞻性观察性队列研究。

机构：第三妇科盆腔疼痛中心。

患者：需服用口服避孕药的原发性痛经患者，自发选择E2/NOMAC（n = 20）或EE/CMA（n = 20）。

主要评估方法：原发性痛经用视觉模拟量表（VAS），简版-36（SF-36）生活质量问卷，脂蛋白及月经经期（服用口服避孕药期间的撤退性出血）。

结果：两组患者的平均年龄与体质量指数（BMI）相似。研究最终分析了34名女性的数据，E2/NOMAC组15名，EE/CMA组19名。EE/CMA组（100%）的治疗依从性显著高于E2/NOMAC组（75%）（p = 0.02）。两种治疗方法均能显著降低患者的原发性痛经VAS评分（p ＜ 0.0001），且效果近似（E2/NOMAC组平均为74.7%，EE/CMA组平均为78.4%；p = 0.973）。E2/NOMAC治疗显著升高患者SF-36评分（p = 0.001），无论在生理维度（p = 0.001）还是心理维度（p = 0.004）。E2/NOMAC组的平均月经经期显著缩短（从4.86 ± 1.20天降至2.64 ± 1.59天，p = 0.0005与基线水平相比，p = 0.007与EE/CMA组相比）。两组的BMI均无变化。E2/NOMAC组患者的脂蛋白与载脂蛋白未发生变化，而EE/CMA可升高患者总胆固醇（p = 0.0114）、HDL（p = 0.0008）、甘油三酯（p = 0.002）、载脂蛋白-A1（Apo-A1；p = 0.0006）及载脂蛋白-B（Apo-B；p = 0.008），降低LDL/HDL（p = 0.024）。

结论：两种口服避孕药对于原发性痛经的缓解作用相似。E2/NOMAC可减少撤退性出血，且对血脂代谢没有影响。

• Chlormadinone acetate
• dysmenorrhea
• estradiol
• ethinyl-estradiol
• metabolism
• nomegestrol acetate
• primary dysmenorrhea
• quality of life

Acknowledgements

We thank Maria Quartieri for assistance in patient management.

Declaration of interest

All authors state explicitly that potential conflicts of interest don’t exist. All authors deny any financial relationship with biotechnology manufacturers, pharmaceutical companies and other commercial entities in relation to this original research study.