Body composition and psychological improvement in healthy premenopausal women assuming the oral contraceptive containing micronized estradiol (E2) and nomegestrol acetate (NOMAC)

Abstract

This observational study was conducted in healthy premenopausal women, who presented themselves for contraceptive advice at the outpatient Family Planning Clinics of the Department of Obstetrics and Gynecology of the University of Cagliari, Hospital–University of Cagliari (Italy). After a screening period of three menstrual cycles, 48 women without contraindications to estroprogestin contraceptives (OCs) were included in the study. The primary purposes of the study were to evaluate whether a 12-month-treatment with the combined OC containing micronized estradiol (1.5 mg, E2) plus nomegestrol acetate (2.5 mg, NOMAC) (E2/NOMAC) interfere on anthropometric indices (AI), body composition (BC) and psychological status (PS). In subjects with dysmenorrhea (#36), its intensity was evaluated using the visuo analogic scale (VAS), both before and during the 12-month-treatment with E2/NOMAC. E2/NOMAC did not modify neither AI nor BC in the 40 subjects who concluded the study. The PS and the VAS of dysmenorrhea were significantly (p < 0.0001) improved from the first cycle of treatment and throughout the E2/NOMAC treatment in comparison with basal values. The study suggests that E2/NOMAC is devoid of negative effects on AI and BC, with additional benefits on PS and dysmenorrhea.

Chinese abstract

此项观察性研究针对健康的绝经前妇女, 这些妇女均在意大利卡利亚里大学附属医院妇产科计划生育门诊进行了避孕咨询。经过三个月经周期的筛查期后, 本研究纳入了48名无雌孕激素避孕药（OCs）应用禁忌证的妇女。研究的主要目的是评估服用12个月微粒化雌二醇(1.5 mg, E2)和醋酸诺美孕酮(2.5 mg, NOMAC) (E2/NOMAC)治疗对人体测量指数(AI)、身体成分(BC)和心理状态(PS)的影响。在12个月的E2/NOMAC治疗前及治疗期间, 用视觉模拟评分法（VAS）评价对于存在痛经的受试者(#36)的痛经强度。在完成研究的40名受试者中, E2/NOMAC并未改变她们的AI和BC水平。与基础值相比, 从第一个月经周期和治疗期间PS水平和痛经的VAS评分均显著改善(p＜0.0001)。研究表明, E2/NOMAC对AI和BC并无负面影响, 对PS和痛经具有额外的益处。

Keywords:

• Body composition
• dysmenorrhea
• hormonal contraception
• micronized estradiol
• multifrequency bioelectrical impedance
• nomegestrol acetate
• psychological status

Acknowledgements

The authors dedicate the work to Dr. Marisa Orrù, who died after a short illness, and after dedicating so much work with passion and professional commitment to this study. Special thanks should be addressed to the staff of the secretariat of obstetrical and gynecological clinic of the University of Cagliari (Ms Franca Fadda, and Ms Maria Frongia). The authors thank Kate Jenkins for revising the English language of the manuscript.

Declaration of interest

The authors report no conflicts of interest.