Long-acting reversible contraception (LARC) with the intrauterine system with levonorgestrel (6 mcg/d): observational study on the acceptability, quality of life, and sexuality in Italian women

Abstract

This observational study was conducted in healthy premenopausal women, who presented themselves for contraception with an intrauterine system (IUS) releasing LNG (6 mcg/d) (Jaydess®, Bayer, Germany) at the outpatient Family Planning Clinics of the Departments of Obstetrics and Gynaecology of the Universities of Cagliari and Sassari (CA/SS), University-Hospitals of CA/SS (Italy). After a screening visit, 31 women without contraindications to Jaydess® were included in the study. No difficulty in Jaydess® insertion (Ji) was found in 87% of subjects, with pelvic pain (PP) (visual analogic scale, VAS:5.33 ± 2.54) reported by 27/31 subjects at the Ji. Pelvic pain was reported by 17/31 subjects on the first day (VAS: 3.07 ± 3.1), 16/31 subjects on the second day (VAS:2.37 ± 2.71), and 11/31 subjects on the third day (VAS:1.18 ± 2.02) from Ji, with a significant (p < .001) decrease in the intensity. The primary purposes of the study were to evaluate whether a 12-month-treatment (12-M-T) with Jaydess® interferes on either the quality of life (QoL) or sexuality. Jaydess® did not modify either QoL or sexuality in the 25 subjects who completed the 12-M-T. Throughout the 12-M-T, PP, or pregnancies were not found; the menstrual blood loss was significantly (p < .0001) reduced, and the intensity VAS of dysmenorrhea (#14 subjects) significantly (p < .001) improved.

Chinese abstract

本次研究对象是健康的绝经前女性, 通过在意大利卡利亚里市和萨萨里市（CA/SS）的大学及其附属医院的妇产科计划生育门诊置入释放左炔诺孕酮(LNG)（6微克/天）的宫内节育系统（IUS）（Jaydess®, 拜耳, 德国）的方式避孕。经筛查后, 本研究共纳入31名无Jaydess®禁忌症的女性。87%的受试对象不存在Jaydess®置入（Ji）困难, 27/31的受试者在Ji后出现盆腔痛（PP）（视觉模拟评分, VAS：5.33 ± 2.54）, 17/31的受试者在Ji后第一天盆腔疼痛（VAS：3.07 ± 3.1）, 16/31的受试者在Ji后第二天盆腔疼痛（VAS：2.37 ± 2.71）, 11/31的受试者在Ji后第三天盆腔疼痛（VAS：1.18 ± 2.02）, 盆腔疼痛强度出现了有统计学意义的下降（p <.001）。本研究的主要目的是评估应用Jaydess®治疗12个月（12-M-T）是否会对其生活质量（QoL）或者性欲造成干扰。在完成12-M-T 的25名受试者中, QoL和性欲全部没有受到Jaydess®的影响。在受试者整个12-M-T中, PP或者妊娠均未发现；月经失血量显著减少（p <.0001）, 14名受试者的痛经强度VAS得到显著缓解（p <.001）。

Keywords:

• Long acting reversible contraception
• jaydess®
• dysmenorrhea
• quality of life
• sexuality

Acknowledgements

Many thanks to nurses Antonella Piras and Paola Orani for supporting women who participated in the study. Special thanks should be addressed to the staff of the secretariat of the department of Obstetrics and Gynaecology 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. All the authors remember with affection, gratitude and esteem their colleague and friend, Dr Marisa Orrù, who left us before the end of the study.

Disclosure statement

The authors report no conflicts of interest.