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

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

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

Femilis™ insertion procedure

• 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

• 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

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

Characteristics of the users: age distribution

Total number = 339

Parous group (years) Nulliparous group (years)

Mean 40 27

Range 20-48 15-48

InsertionEASE OF INSERTION (%)

(N = 339: 178 Parous and 161 nulliparous women)

Ease of insertion Parous Nulliparous

Easy 97.2 % 98.8%

Difficult 2.8 % 1.2%

Cumulative events at three yearTotal Group Parous Nulliparous

Pregnancy1 1 0 1Expulsion2 9 2 7Pain/bleeding3 15 5 10‘Other medical’ rem4 11 6 5Non-medical removals5 24 6 18Total use related disc. 48 (14.1) 17 (9.5) 31 (19.2)Loss to follow-up 10 5 5Continuation 291 (85.8) 161 (90.4) 130 (80.7)Women recruited 339 178 161

Women-months of use 6165 3482 2683

1After expulsion2Mainly partial expulsions (the majority due to shortcomings of the Femilis Slim)3Mainly pain (only 4 for bleeding disturbances) 4Hysterectomy (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 disturbances5Pregnancy wish (14), Against hormones (2), new partner sterilized (1), removal after expiry (6), 1 died (non-related: Hodgkin)

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 80-160) and dropped

to a median score of 5 (range 0-150) at

follow-up, a decrease of 96%.

Amenenorrhoea occurred in 30% .

0

20

40

60

80

100

120

140

Before After

Median Scores4-30 months FU

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 185-450) 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

0

50

100

150

200

250

Before After

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