Comparative randomized study on the sexual function and quality of life of women on contraceptive vaginal ring containing ethinylestradiol/etonogestrel 3.47/11.00mg or 2.7/11.7mg

Abstract

The objective of the study was to evaluate the sexual function and quality of life (QoL) of healthy women on a new contraceptive vaginal ring (CVR) containing ethinylestradiol (EE) 3.47 mg and etonogestrel (ENG) 11.00 mg (study group) manufactured with a new polymer composition compared to EE 2.7 mg/ENG11.7 mg CVR (control group). Fifty-eight women were randomly allocated to the study group and the control group. The Female Sexual Function Index (FSFI), the Female Sexual Distress Scale (FSDS) and the Short Form-36, were used to assess sexual function, sexual distress and QoL, respectively. The study included two follow-ups, at 90 days and at 180 days. The control group reported more adverse events, mainly breakthrough bleeding, than the study group. The sexual function scores in the women in the study group improved with respect to those of the control group both at the 1st (FSFI, p = .009; FSDS, p = .001) and at the 2^nd (FSFI, p = .001; FSDS, p = .002) follow-up. QoL of the study group improved at the 1^st follow-up (p < .05) and 2^nd (p < .01) follow-up. The control group improved their QoL at the 2nd follow-up (p < .01). The more gradual EE release of the new polymer composition could justify the behavioral differences of the women of the two groups.

摘要

本研究的目的是应用一种含有3.47mg炔雌醇（EE）和11.00 mg依托诺孕酮（ENG）的新型避孕阴道环（CVR）后评估健康女性的性功能和生活质量（QoL）, 与对照组CVR（EE 2.7 mg /Eng11.7mg）的不同之处在于该环由一种新的聚合物成分制成。58名妇女被随机分配到研究组和对照组。应用女性性功能指数（FSFI）、女性性痛苦量表（FSDS）及短表-36分别对女性性功能、性痛苦和生活质量进行评估。研究包括两次随访, 分别是90天和180天。对照组报告的不良事件比研究组多, 主要是突破性出血。研究组女性的性功能评分在第一次（FSFI, p=0.009；FSDS, p=0.001）和第二次（FSFI, p=0.001；FSDS, p=0.002）随访时均较对照组有所改善。研究组女性的生活质量在第一次随访（P<0.05）和第二次随访（P<0.01）均有所改善。对照组女性生活质量在第二次随访时才有所改善（P<0.01）。新的聚合物成分释放的EE可以证明两组女性的行为差异。

The Chinese abstracts are translated by Prof. Dr. Xiangyan Ruan and her team: Beijing Obstetrics and Gynecology Hospital, Capital Medical University, Beijing 100026, China.

Keywords:

• Contraceptive vaginal ring
• CVR polymer composition
• FSFI
• quality of life
• sexual activity

Acknowledgements

The authors wish to thank the Scientific Bureau of the University of Catania for language support.

Disclosure statement

No potential conflict of interest was reported by the authors.