Contraception with a novel 'frameless' intrauterine levonorgestrel-releasing drug delivery system: a pilot study.
OBJECTIVE
To evaluate the contraceptive performance, acceptability, side-effects and adverse events of a novel 'frameless' intrauterine drug delivery system, the FibroPlant levonorgestrel intrauterine system, releasing 14 microg of levonorgestrel/day. An ancillary objective was to evaluate the effect of the new intrauterine system on menstrual blood loss.


METHODS
This was an open-label, non-comparative, ongoing pilot study. Fifty-four insertions were performed by the first author in fertile women between 16 and 51 years of age for contraception. Eighteen of these women were fitted with the FibroPlant levonorgestrel intrauterine system for the treatment of excessive bleeding as well as for contraceptive purposes. Of these women, 12 had medium-to-large-sized uterine fibroids in addition to heavy menstrual flow. The follow-up period of the trial was between 6 and 16 months.


RESULTS
At the time of study analysis the total number of woman-months was 464 and 21 women had had the FibroPlant levonorgestrel intrauterine system in place for more than 1 year. No pregnancies occurred. All women reported greatly reduced bleeding; however, no cases of amenorrhea resulting from endometrial suppression were encountered. Significant spotting was rare after the first 3 months following insertion. No complications (e.g. infection, expulsion or perforation) occurred. The FibroPlant levonorgestrel intrauterine system was well tolerated by all women involved in the study and no systemic hormonal side-effects were reported.


CONCLUSIONS
Although the average age of the study subjects was 40 years, this preliminary study suggests that the FibroPlant levonorgestrel intrauterine system is an effective contraceptive. The FibroPlant levonorgestrel intrauterine system is also highly efficacious in controlling bleeding in women presenting with excessive menstrual flow. Effective endometrial suppression is the principal mechanism underlying both the contraceptive effect and the effect on menstrual blood loss. The low release rate oflevonorgestrel results in an absence of hormonal side-effects. The unique 'frameless' design characteristics of the intrauterine system facilitate insertion and minimize pain and discomfort. These factors, together with the low incidence of amenorrhea, appear to be a significant step forward from the 'framed' Nova-T levonorgestrel intrauterine system (Mirena).
Wildemeersch
D
D
Control Research, Technology Park Zwijnaarde, Ghent, Belgium.
Schacht
E
E
D000293:Adolescent; D000328:Adult; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007436:Intrauterine Devices, Medicated; D016912:Levonorgestrel / Q000008:administration & dosage* / Q000009:adverse effects; D008875:Middle Aged; D010865:Pilot Projects; D045167:Progesterone Congeners / Q000008:administration & dosage* / Q000009:adverse effects; D014592:Uterine Hemorrhage / Q000517:prevention & control*
D045167:Progesterone Congeners; D016912:Levonorgestrel