Abstract
Objective
The objective was to evaluate the efficacy and safety of a low-dose levonorgestrel
intrauterine system with total content 13.5 mg (average approximately 8 μg/24 h over
the first year; LNG-IUS 8; Jaydess®) in an Asia-Pacific population.
Study design
An open-label, single-arm phase III study conducted at 25 centers in China, Australia
and Korea assessed LNG-IUS 8 use over 3 years in nulliparous and parous women (N=1114) aged 18–40 years with regular menstrual cycles (21–35 days). Primary outcome
was pregnancy rate, expressed as the Pearl Index. Secondary outcomes included 3-year
cumulative failure rate, treatment-emergent adverse events (TEAEs), discontinuation
rate, bleeding profile and placement pain.
Results
The full analysis set comprised 925 women (mean age 31.6 years, 6.4% nulliparous).
Overall unadjusted Pearl Index was 0.35 (95% confidence interval 0.15–0.70); the 3-year
cumulative failure rate was 0.9% (95% confidence interval 0.4–1.9). TEAEs and study
drug-related TEAEs were reported in 70.1% and 31.2% of women, respectively. Overall,
27.9% of women discontinued the study, 16.9% due to adverse events. Frequent or prolonged
bleeding (World Health Organization criteria) decreased from the first to the twelfth
90-day reference intervals (from 5.0% to 0.7% and from 44.1% to 3.0%, respectively),
and the percentage of women with amenorrhea increased over time (from 0.4% to 10.8%).
Pain on placement was reported as “none” or “mild” in 91.9% of women.
Conclusions
LNG-IUS 8 was an effective and well-tolerated contraceptive method, providing another
option for women in the Asia-Pacific region.
Implications
In this phase III study, LNG-IUS 8 was shown to be highly effective and well tolerated
in an Asia-Pacific population and was not associated with any new or unexpected safety
events. LNG-IUS 8 provides another contraceptive option for women in the Asia-Pacific
region.
Keywords
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Article info
Publication history
Published online: November 29, 2016
Accepted:
November 22,
2016
Received in revised form:
November 10,
2016
Received:
December 15,
2015
Footnotes
☆Clinical trial registration number: NCT00884260.
☆☆Conflicts of interest:
☆☆Dr. Guangsheng Fan has provided expert opinion for Bayer HealthCare and Merck Sharp & Dohme and has been supported to present at, and attend, conferences by Bayer HealthCare. Dr. Fan's institution received grants from Bayer HealthCare for conducting this phase III clinical trial of LNG-IUS 8.
☆☆Dr. Sukho Kang has provided expert opinion for Bayer HealthCare.
☆☆Prof. Mulan Ren has provided expert opinion for AstraZeneca, Bayer HealthCare, Merck Serono, Merck Sharp & Dohme and Takeda and has been supported to present at, and attend, conferences by Bayer HealthCare.
☆☆Dr. Edith Weisberg has provided expert opinion for Bayer HealthCare and Merck Sharp & Dohme, has been supported to attend conferences by Bayer HealthCare and has obtained research funding for investigator-initiated research from both companies.
☆☆Dr. Eeva Lukkari-Lax is an employee of Bayer Oy, Finland.
☆☆Dr. Katrin Roth is an employee of Bayer Pharma AG, Berlin, Germany.
☆☆Dr. SoYoung Shin is an employee of Bayer HealthCare Pharmaceuticals, Seoul, Republic of Korea.
Identification
Copyright
© 2016 Published by Elsevier Inc.
