Treatment of menorrhagia with a novel 'frameless' intrauterine levonorgestrel-releasing drug delivery system: a pilot study

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Objective To evaluate the effect on menstrual blood loss of a novel 'frameless' intrauterine drug delivery system, the FibroPlant™ levonorgestrel intrauterine system (IUS), releasing14 μg of levonorgestrel/day. An ancillary objective was to evaluate the contraceptive performance.Study design This was an open-label, non-comparative ongoing pilot study. Thirty-two insertionswere performed in fertile women aged between 31 and 51 years for the treatment of menorrhagia, as well as for contraceptive purposes. Fifteen women who developed excessive bleeding were fitted with theFibroPlant levonorgestrel IUS immediately following the removal of a copper-bearing intrauterine device (IUD), the GyneFix® IUD. To discriminate between menorrhagia and normal menstrual bloodloss, women were evaluated using a simple visual assessment technique. The trial covered a period from a minimum of 1 month up to 23 months.Results At the time of study analysis, the total numberof woman-months was 361. Fourteen of the women had had the FibroPlant levonorgestrel IUS in place for more than 1 year, and 29 women for 6 months or more. All women reported greatly reduced bleeding. However,no cases of amenorrhea resulting from endometrial suppression were encountered. The reduction of bleeding was substantial after 1 month of treatment and decreased further over the next months to remainstable thereafter. The mean bleeding score before treatment was 338 (range 185–740) in the group who had had no prior use of an IUD and 368 (range 185–890) in the group with prior IUD use. Themean bleeding score dropped to a mean score of 70 (range 5–210) in the 'no prior IUD use' group and to a mean score of 52 (range 3–150) in the 'prior IUD use' group, after 1–23 monthsof follow-up. This result is highly statistically significant (p < 0.001). There were no statistical differences in bleeding scores before and during treatment between the two groups of women,with or without prior use of the copper IUD.Significant spotting was rare after the first 3 months following insertion. No complications (e.g. infection, expulsion or perforation) or pregnancies occurred.The FibroPlant levonorgestrel IUS was well tolerated by all women involved in the study and no systemic hormonal side-effects were reported.Conclusion The FibroPlant levonorgestrel IUS is effectivein significantly reducing the amount of menstrual blood loss in women with menorrhagia. Strong endometrial suppression is the principal mechanism explaining both the effect on menstrual blood loss and thecontraceptive performance of the IUS. There were no differences in bleeding scores before and during treatment between the two groups of women with or without prior use of the copper IUD, suggesting thatthe development of heavy bleeding was not related to the use of the IUD.The therapeutic effect of this contraceptive method is highly desirable, particularly in women with heavy bleeding or anemiain developing countries, as other treatment modalities are less effective, more costly, more invasive or inaccessible. The low daily release rate of levonorgestrel from the FibroPlant levonorgestrel IUSresults in a low incidence of hormonal side-effects and reduces the likelihood of amenorrhea. The simple design characteristics and revolutionary anchoring system minimize the occurrence of complaints ofpain and the incidence of expulsion.