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D. Wildemeersch, D. Janssens, M. Vrijens Contrel Research, Belgium 9th Congress of the European Society of Contraception. Istanbul, May 2006 Ease and safety.

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Presentation on theme: "D. Wildemeersch, D. Janssens, M. Vrijens Contrel Research, Belgium 9th Congress of the European Society of Contraception. Istanbul, May 2006 Ease and safety."— Presentation transcript:

1 D. Wildemeersch, D. Janssens, M. Vrijens Contrel Research, Belgium 9th Congress of the European Society of Contraception. Istanbul, May 2006 Ease and safety of insertion, contraceptive performance and effect on menstrual blood loss of a new LNG-IUS, Femilis, in parous and nulliparous women

2 Femilis vs. Mirena ® - LNG IUS Femilis is slighly smaller (shorter and slimmer stem and shorter crossarms) More suitable for use in nulliparous women Both release approximately 20 g of LNG per day The stem is loaded with 60 mg of LNG vs 52 mg with Mirena The lifespan at least 5 years

3 Femilis insertion procedure

4 Evaluate ease of insertion, Safety of the insertion technique, Contraceptive performance, Evaluate expulsion and user-continuation rates Evaluate reduction of MBL in a subset of women Objective

5 An open, prospective non-comparative study (interim analysis) 339 insertions were performed in women between 15 and 48 yr of age seeking contraception Of these, 178 (52.5%) parous women received Femilis and 161 (47.5%) nulliparous women were fitted with Femilis Slim and with Femilis Design and methods

6 Femilis Slim and Femilis Femilis Slim is slighly smaller than Femilis Both release approximately 20 g of LNG per day The stem is loaded with 40 mg of LNG vs 60 mg with Femilis The lifespan at least 3 years instead of 5 years Due to shortcomings of the small IUS, it was decided to continue the study in nulliparous women with Femilis instead of the Femilis Slim

7 Characteristics of the users: age distribution Total number = 339 Parous group (years)Nulliparous group (years) Mean Range

8 Insertion EASE OF INSERTION (%) (N = 339: 178 Parous and 161 nulliparous women) Ease of insertionParousNulliparous Easy97.2 %98.8% Difficult2.8 %1.2%

9 Cumulative events at three year Total GroupParousNulliparous Pregnancy Expulsion Pain/bleeding Other medical rem Non-medical removals Total use related disc. 48 (14.1) 17 (9.5) 31 (19.2) Loss to follow-up 1055 Continuation 291 (85.8)161 (90.4)130 (80.7) Women recruited Women-months of use After expulsion 2 Mainly partial expulsions (the majority due to shortcomings of the Femilis Slim) 3 Mainly pain (only 4 for bleeding disturbances) 4 Hysterectomy (2 for significant fibroids, 1 for abnormal bleeding after endometrial ablation, 1 for cervix ca), 2 for weight gain, 1 for ovarian cyst, 4 for mood disturbances 5 Pregnancy wish (14), Against hormones (2), new partner sterilized (1), removal after expiry (6), 1 died (non-related: Hodgkin)

10 Femilis in women without idiopathic menorrhagia (n=28) (visual menstrual score technique) MBL scores dropped significantly (p<0.001) during the observation period in all women except one. The median menstrual score at baseline in women with normal menstrual bleeding was 140 (range ) and dropped to a median score of 5 (range 0-150) at follow-up, a decrease of 96%. Amenenorrhoea occurred in 30%. Median Scores 4-30 months FU

11 Femilis in women with idiopathic menorrhagia (n=32) (visual menstrual score technique) In women with menorrhagic bleeding (score 185) at baseline, menstrual flow dropped from a median score of 232 (range ) at baseline to a median score of 3 (range 0-50) at the last follow-up visit, a decrease of 99%. Amenorrhoea occurred in 30%. Median Scores 4-30 months FU

12 Conclusion The Femilis LNG-IUS is an effective contraceptive It is easily inserted and well tolerated in parous as well as nulliparous women The simple and safe insertion procedure could be an advantage for use by non-specialist providers such as nurses, midwives, general practitioners, and for those not inserting intrauterine devices regularly. The strong effect on MBL offers an important health benefit and improvement in quality of life, particularly in women with heavy bleeding and anemia


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