Bleeding profile satisfaction and pain and ease of placement with levonorgestrel 19.5 mg IUD: findings from the Kyleena^® Satisfaction study

Abstract

Purpose

To investigate bleeding profile satisfaction and pain and ease of placement with levonorgestrel 19.5 mg IUD in routine clinical practice.

Methods

Women who independently chose levonorgestrel 19.5 mg IUD during routine counselling were invited to participate in this prospective, multinational, observational study. Patient-reported pain and clinician-reported ease of placement were assessed. Bleeding profile satisfaction was evaluated at 12 months/premature end of observation.

Results

Most participants (77.8%, n = 878/1129) rated levonorgestrel 19.5 mg IUD placement pain as ‘none’ or ‘mild’ and most clinicians (91.1%, n = 1029/1129) rated placement as ‘easy’. Pain was more often rated higher in nulliparous compared with parous (p < .0001) and younger (<26 years) compared with older participants (p < .0001), although 67.7% and 69.0% of nulliparous and younger participants respectively reported ‘none’ or ‘mild’ pain. Bleeding profile satisfaction at 12 months/end of observation was similar in parous (72.9%, n = 318/436) and nulliparous (69.6%, n = 314/451) participants. Most participants irrespective of age reported bleeding profile satisfaction, ranging from 67.8% (n = 206/304) for 18–25 years to 76.5% (n = 218/285) for >35 years.

Conclusion

We observed high bleeding profile satisfaction regardless of age or parity with levonorgestrel 19.5 mg IUD and confirmed that device placement is easy and associated with no more than mild pain in most cases in routine clinical practice. Real-world evidence from the Kyleena^® Satisfaction Study in routine clinical practice shows high bleeding profile satisfaction with levonorgestrel 19.5 mg IUD regardless of age or parity. IUD placement was easy and associated with little to no pain for most women.

摘要

目的:探讨临床常规放置19.5mg左炔诺孕酮宫内节育器(IUD)时的出血情况、满意度、疼痛及便利性。

方法:本研究为前瞻性、多中心、观察性研究。评估患者报告的疼痛和临床医生报告的放置轻松度。在应用12个月或观察提前结束时评估出血情况满意度。

结果:大多数参与者(77.8%, n=878/1129)将放置19.5 mg左炔诺孕酮 IUD疼痛评为“无”或“轻度”, 大多数临床医生(91.1%, n=1029/1129)将放置难易程度评为“容易”。未生育过的女性的的疼痛程度高于生育过的女性(p <0 .0001)及更年轻的女性(p <0 .0001), 尽管67.7%和69.0%的未生育过的女性和较年轻的女性分别报告“没有”或“轻度”疼痛。观察12个月或者研究结束时, 生育过的女性(72.9%, n=318/436)和未生育过的女性(69.6%, n=314/451)的出血情况满意度相似。大多数参与者(不论年龄)报告对出血情况满意, 18-25岁出血满意情况为67.8% (n=206/304), 35岁以上满意程度为76.5% (n=218/285)。

结论:我们观察到, 无论年龄或者是否生育过, 19.5 mg左炔诺孕酮节育器的出血情况都有较高的满意度, 并证实在常规临床实践中, 大多数情况下放置节育器很容易, 并且与轻度疼痛无关。来自常规临床实践Kyleena®满意度研究的真实世界结果表明, 无论年龄或是否生育过, 19.5 mg的左炔诺孕酮IUD的出血情况都有很高的满意度。放置宫内节育器很容易, 对大多数女性来说几乎没有疼痛。

ClinicalTrials.gov identifier::

• NCT03182140

Keywords:

• Intrauterine device
• levonorgestrel-releasing intrauterine device
• hormonal contraception
• bleeding profile
• long-acting reversible contraception
• placement pain
• contraceptive satisfaction

Acknowledgements

The authors would like to thank all the investigators for their participation and continued commitment to the study. The authors would also like to acknowledge funding from Bayer AG, Berlin, Germany, and to acknowledge Highfield, Oxford, UK, for providing medical writing assistance with funding from Bayer AG.

Disclosure statement

Gilbert Donders has been a member of a medical advisory board for Bayer Belgium since 2010, and his research centre has received fees for lectures and research from Bayer, Gedeon Richter, Merck Sharp & Dohme (MSD), Medinova and Mycovia. Helena Kopp Kallner has received honoraria for lectures from Actavis, Bayer, Exeltis, Gedeon Richter, Merck, Mithra, Natural Cycles, Nordic Pharma and Teva, and teaches courses sponsored by Bayer, Merck and MSD; she has also provided expert opinion for Bayer, Evolan, Exeltis, Gedeon Richter, Merck, Natural Cycles, Teva and TV4, and is an investigator in trials sponsored by Bayer, Gedeon Richter, Mithra and MSD. Brian Hauck is on medical advisory boards for Allergan, Bayer, Merck, Pfizer and Searchlight. Anja Bauerfeind is a full-time employee of ZEG Berlin/Cerner Enviza, Berlin, Germany. Ann-Kathrin Frenz and Michal Zvolanek are full-time employees of Bayer AG, Berlin/Wuppertal, Germany. Dale Stovall has received honoraria from Bayer for educational lectures.

Additional information

Funding

The study was funded by Bayer AG, Berlin, Germany. Bayer AG was responsible for the study design, data collection and analysis, and overall conduct of the study.