Ease of insertion, contraceptive efficacy and safety of new T-shaped
levonorgestrel-releasing intrauterine systems – First clinical report
D. Wildemeersch (1), D. Janssens (2) , M. Vrijens (3), S. Weyers (4)
Contrel Research, Technology Park Zwijnaarde, Ghent, Belgium (1)
Gynecologische Dienst, Turnhout, Belgium (2) Gynecologische Dienst, Gent,
Belgium (3) Department of Obstetrics and Gynecology, University Hospital Ghent,
Ghent, Belgium (4)
Objective: The objective of the study is to evaluate ease of insertion,
contraceptive performance and safety, in parous and nulliparous women, of two
new T-shaped levonorgestrel (LNG)-releasing intrauterine systems (T-LNG-IUS),
FemilisTM LNG-IUS and FemilisTM Slim LNG-IUS, releasing 20
µg of LNG/day. An ancillary objective is to evaluate expulsion and
user-continuation.
Design and methods: An open, prospective non-comparative study
(interim analysis). Two hundred and fifty-eight insertions were performed in
fertile women for contraception. From these, 143 (55.5%) parous women were
fitted with Femilis-LNG IUS and 115 (44.5%) nulliparous women were fitted with
Femilis Slim LNG-IUS. The LNG-IUS is inserted using a simplified push-in
technique (without folding the cross-arms in the insertion tube).
Results: This paper is the first (interim) report with the Femilis
LNG-IUS. The push-in technique of insertion was considered simple and safe.
Insertion was reported ‘easy’ in virtually all women (98%). Pain at
insertion was absent in 23.6% and ‘mild’ in 64.7% of women. At the time of
study analysis the total number of women-months was 1,867. Seventy-eight women
had the T-LNG-IUS in place for periods in excess of one year. The study was well
followed-up with lost-to-follow-up of 3 woman only. No pregnancies were observed.
The following events occurred: there were 3 expulsions in the nulliparous and 1
in the parous group. Fifteen removals were performed for medical reasons (mainly
bleeding and pain). One pelvic infection occurred in a nulliparous women caused
by Chlamydia trachomatis which was cured without removing the IUS. There were no
serious adverse events (e.g. perforation) reported. Both the standard and slim
version of T-LNG-IUS were well tolerated which resulted in a high continued use
(91.4%).
Conclusion: The Femilis LNG-IUS insertion procedure is simple and
safe. The results of this one-year study are in agreement with those observed
with the Mirena® and frameless FibroPlantTM LNG-IUS. However, the
simple and safe insertion procedure could be an advantage for use by
non-specialist providers (e.g. nurses, midwives, general practitioners), and for
those not using the LNG-IUS regularly, and contribute to an increased prevalence
of use of the method. Femilis Slim could be an attractive long-term
contraceptive option in young, including adolescent women. The study analysis
will be updated for the presentation.
