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Objective: To provide an update on the experience with the Femilis levonorgestrel-releasing intrauterine system (LNG-IUS) used for up to five years by parous and nulliparous women, particularly with regard to its contraceptive performance., Study Design: An interim, open, prospective non-comparative study of the Femilis LNG-IUS releasing 20 microg of levonorgestrel/day., Results: Two-hundred and eighty insertions were carried out in women with a mean age of 35.7 years (range 17-48), 60% of whom were parous and 40% nulliparous. Twenty-four women with uterine pathology (e.g., fibroids, menorrhagia) were included in the study. The cumulative gross discontinuation life table rates were determined. The total observation period was 8,028 woman-months. The LNG-IUS was easy to insert in 95.7% of the cases, and no perforations occurred. No pregnancies were observed and only one expulsion took place (rate 0.4/100 women at five years). The cumulative total use-related discontinuation rate was 14.7/100 at five years. There were nine removals because of pain, six of which were in nulliparous women. Four women requested removal of the IUS for bleeding problems. Fourteen removals were done for 'other' medical reasons among which mood disturbances (five cases) were the most frequent, and 12 for non-medical reasons. Fifteen removals were requested for pregnancy wish. Twelve of these women became pregnant within one year and all had uneventful pregnancies. The Femilis LNG-IUS was equally well accepted by nulliparous as by parous women. Most women with heavy menstrual bleeding prior to insertion, whether associated with fibroids or not, reported much less bleeding, scanty bleeding or even no bleeding at all after insertion., Conclusion: This study suggests that the Femilis LNG-IUS, which releases 20 microg LNG/d, is a highly effective, well tolerated and well retained contraceptive both in parous and nulliparous women. The shorter crossarm of the LNG-IUS has simplified its insertion technique, which may contribute to its safety. This could promote use by non specialist providers and enhance the application of the method.

Objectives: Levonorgestrel (LNG), delivered locally into the uterine cavity has a profound effect on the endometrium. The aim of the study was to use a LNG intrauterine system to treat non-atypical and atypical endometrial hyperplasia in women and to evaluate the long-term cure (remission) rate., Methods: Each of the 20 women in the study, of whom eight were diagnosed with atypical hyperplasia, received a LNG-IUS, releasing 20 microg LNG/day. The study is a non-comparative study with long-term follow-up (range 14-90 months)., Results: All women developed a normal endometrium, except one asymptomatic woman with atypical hyperplasia who still had focal residual non-atypical hyperplasia at 3 years follow-up in the presence of a thin (< 4 mm) endometrium., Conclusion: Continuous intrauterine delivery of LNG appears to be a promising alternative to hysterectomy for the treatment of endometrial hyperplasia and could enhance the success rate when compared with other routes of progestagen administration as well as intrauterine progesterone delivery. The significant reduction of the PR expression observed during treatment with the LNG-IUS appears to be a marker for the strong antiproliferative effect of the hormone at a cellular level resulting in an inhibition of estrogen bioactivity and endometrial suppression.

Objective: To evaluate ease of insertion, acceptability and endometrial safety of a novel, miniature intrauterine, T-shaped, levonorgestrel (LNG)-releasing intrauterine system (IUS), Femilis Slim LNG-IUS (Contrel Research, Belgium), combined with parenteral estrogen substitution therapy (EST) in postmenopausal women., Design: A prospective, non-comparative, study in postmenopausal women. A 3.0 cm long and 2.0 mm wide coaxial fibrous delivery system, delivering approximately 20 microg/day of levonorgestrel (LNG) was used. The drug compartment is provided with crossarms fixed to the upper part of the drug delivery rod. The calculated duration of release of the system is at least 5 years. The majority of women received percutaneous 17beta estradiol (Oestrogel, Besins Int., Belgium), 1.5 mg daily on a continuous basis, which provides sufficient blood levels of estrogen in most women to suppress climacteric symptoms and protection against bone loss., Primary Outcome Measures: ease of insertion, retention and side effects of the T-LNG Slim IUS., Secondary Outcome Measures: endometrial safety assessed by transvaginal ultrasound examination and by endometrial biopsy in a subset of women., Results: One hundred and seventy insertions were performed in postmenopausal women with median age of age 56.6 (range 43.5-80.3). Insertion was easy in 161 (94.2%) and difficult in 9 (5.3%) women. Pain at insertion was rated as none in 57 women (33.5%), mild in 105 (61.7%), moderate in 7 (4.1%) and severe in 1 (0.5%) woman. The system was well retained in the uterus as no expulsions occurred. At the time of study analysis, the total number of women-months was 1797.5. Ninety-five women had the T-LNG-IUS in place for periods in excess of 1 year. The study was well followed-up with lost-to-follow-up rate (defined as no follow-up during 12 months) of zero at the time of study analysis. The number of women continuing the method was 160 (94.1%) including four women which were released from follow-up for various non-medical related reasons. The histological examinations conducted in 105 women showed predominantly inactive endometrium characterized by a pseudo-decidual reaction of the endometrial stroma with endometrial atrophy. The mean thickness (double-layer) of the endometrium was 3.3 mm (range 2-5 mm) which correlated well with the histology results., Conclusions: The results suggest that the small T-LNG-IUS is easy to insert in most postmenopausal women without anaesthesia and dilatation of the cervix. It is well tolerated, well accepted and effective in suppressing the endometrium during EST. The lack of expulsions of the device in this study is attributed to the optimal design characteristics of the IUS, the absence of uterine bleeding and absent or reduced contractility of the uterus. The study confirms earlier studies conducted with other LNG-releasing systems used for endometrial suppression during EST. The ease of insertion of the small LNG-IUS could be an important incentive to expand the use of the continuous combined regimen with local delivery of the progestogen. It could be a method of choice for endometrial suppression in women using EST with fundamental advantages to systemically applied progestogens which have been the subject of considerable debate as reported in the recent literature.

Objective: To evaluate the acceptability and endometrial safety of a novel intrauterine drug delivery system, FibroPlant-levonorgestrel (LNG), combined with estrogen therapy (ET) in 150 peri- and postmenopausal women, followed-up for at least 3 years., Design: This was a prospective, non-comparative study in peri- and postmenopausal women. In the majority of women, treatment with the FibroPlant-LNG intrauterine system (IUS), combined with ET, was initiated during the perimenopausal transitional phase to establish a smooth transition to menopause and suppress the endometrium to prevent endometrial proliferation and bleeding. A 3.5-cm long coaxial fibrous delivery system, delivering approximately 14 microg LNG/day, was used. The calculated duration of release of the system is at least 3 years. The majority of women received percutaneous 17beta-estradiol (Oestrogel), 1.5 mg daily on a continuous basis, which provides sufficient blood levels of estrogen in most women to suppress climacteric symptoms and protect against bone loss., Outcome Measures: To measure acceptability, women were asked, after they had the IUS in place for a minimum of 3 years, if they would like to continue the combined regimen and if they would accept renewal of the IUS. Endometrial safety was evaluated by transvaginal ultrasound examination and endometrial biopsy in a subset of 101 women prior to replacement of the IUS., Results: Ninety-four insertions were done in perimenopausal and 56 in postmenopausal women aged between 33 and 78 years. Of the total group of 150 women, 132 women (88.0%) accepted replacement of the IUS and ten are waiting for replacement. This group includes nine women who will receive a second replacement. The number of women continuing the method is 142 (94.6%). Histological examinations conducted on endometrial biopsies from 101 postmenopausal women prior to replacement, after an average period of use of the regimen of 40 months (range 25-50 months), showed predominantly inactive endometrium characterized by pseudodecidual reaction of the endometrial stroma with endometrial atrophia, which is in keeping with the effects seen with a progestogenic compound. There were no specimens showing signs of proliferation., Conclusions: Results suggest that the frameless FibroPlant-LNG IUS is safe, well tolerated, well accepted and effective in suppressing the endometrium during ET. Intrauterine progestogen administration in postmenopausal women can be regarded as fundamentally advantageous compared with systemically applied progestogens, which may have potentially inherent ill side-effects, especially on the breast and cardiovascular system, as reported in the recent literature.

Objective: The objective of the study was to evaluate ease of insertion, contraceptive performance and safety, in parous and nulliparous women, of two new T-shaped levonorgestrel (LNG)-releasing intrauterine systems (LNG-IUS), Femilistrade mark (parous women) and Femilis Slim (nulliparous women), releasing 20 mug of LNG per day. An ancillary objective was to evaluate expulsion and user continuation., Design and Methods: An open, prospective, noncomparative study (interim analysis). Two hundred thirty-five insertions were performed in fertile women seeking contraception. Of these, 143 (60.8%) parous women were fitted with Femilis and 92 (39.2%) nulliparous women were fitted with Femilis Slim. The LNG-IUS was inserted using a simplified push-in technique (without folding the cross-arms in the insertion tube)., Results: This paper is the first 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 (97.9%). Pain at insertion was absent in 24.7% and "mild" in 67.7% of women. With respect to pain, there were no statistical differences between the parous and nulliparous group. At the time of study analysis, the total number of women-months of use was 1769.7. Seventy-six women had the Femilis IUS in place for periods in excess of 1 year. The study was well followed up with lost to follow-up of only two women. No pregnancies were observed. There was one expulsion in the nulliparous and one in the parous group. Ten removals were performed for medical reasons (mainly bleeding and pain). One pelvic infection occurred in a nulliparous woman caused by Chlamydia trachomatis, which was resolved without removing the IUS. There were no other serious adverse events reported. Both Femilis and Femilis Slim were well tolerated, which resulted in a high continuation rate (94.04%)., Conclusion: The Femilis LNG-IUS is an effective contraceptive and is easily inserted. The simple and safe insertion procedure could be an advantage for use by nonspecialist providers such as nurses, midwives, general practitioners, and for those not inserting intrauterine devices regularly. Femilis Slim could be an attractive long-term contraceptive option in young and adolescent women.