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New Long-Acting Reversible Contraception Option

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Jaydess is a new option in intra-uterine contraception which adds to the other available option Mirena.  The rationale for the development of Jaydess is a shorter maximum duration of use and a lower daily levonorgestrel release rate, which result in a smaller reservoir and therefore an easier and less painful placement.

Jaydess – Small T-body with narrow insertion tube and low dose

Jaydess Mirena
T-frame dimension 28mmx30mm, including silver ring 32mmx32mm
Insertion tube diameter 3.80mm (with Evolnserter) 4.4mm (with Evolnserter)
Initial in vivo LNG release rate 6µg/day (average over 3 years) 20µg/day (not same timepoint or calculation model)
Maximum duration of use 3 years 5 years
Total LNG content 13.5mg 52mg

LNG: levonorgestrel

Study Results

Phase III study of 2,884 women aged 18-35 comparing Jaydess with another low dose intra-uterine system1
  • Jaydess was highly effective, with a three year Pearl Index* of 0.33.
  • Jaydess caused shorter, less frequent bleeding over time during use.
  • Jaydess was well tolerated.
  • Jaydess was associated with low incidence of ectopic pregnancy, pelvic inflammatory disease, perforation and expulsion.
  • 95% of women surveyed rated themselves as very satisfied or somehow satisfied.

Phase II study of 742 women aged 21-40 comparing Jaydess and Mirena2

  • Jaydess provided a good contraceptive efficacy for 3 years, with a similar bleeding profile to that of Mirena, and reduced likelihood of amenorrhea.
  • Placement of Jaydess was significantly easier compared to placement of Mirena (investigator’s perspective).
  • Placement of Jaydess was significantly less painful, with 72% of women reporting no pain or only mild pain with Jaydess, compared to 58% with Mirena (women’s perspective).
  • The only significant difference in treatment-related adverse events between the two intrauterine systems was the incidence in ovarian cyst, which was found to be lower with Jaydess (5.9% vs 22% with Mirena).

*Pearl Index: Number of failures per 100 woman years of exposure

Conclusion

Dr Daragh O’Neill, GP, with a specialist interest in women’s health and tutor in contraception, commented on the results: “In Ireland, Mirena has been used mainly by women over 35 years, so a smaller, lower-dose device could suit a larger range of women, including the younger woman”.

See also:

Long-Acting Reversible Contraception

References:

1- Nelson A, Apter D, et al. Two low-dose levonorgestrel intrauterine contraceptive systems: a randomized controlled trial. Obstet Gynecol. 2013 Dec;122(6):1205-13.

2- Gemzell-Danielsson K1, Schellschmidt I, Apter D. A randomized, phase II study describing the efficacy, bleeding profile, and safety of two low-dose levonorgestrel-releasing intrauterine contraceptive systems and Mirena. Fertil Steril. 2012 Mar;97(3):616-22.

 

More on Contraception:

List of Combined Oral Contraceptives Available in Ireland

Side-effects of Combined Oral Contraceptives


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