Assessment of menstrual blood loss in Belgian users of a new T-shaped levonorgestrel-releasing intrauterine system.
OBJECTIVE
This study was conducted to evaluate the effect of a T-shaped levonorgestrel-releasing intrauterine system (Femilis, LNG IUS) on the amount of menstrual blood loss (MBL) in women with and without menorrhagia. The daily release of the LNG IUS was approximately 20 mug.


METHODS
In 60 Belgian women, less than 48 years of age at study enrollment, using the Femilis LNG IUS for 4 to more than 30 months, MBL was assessed with the visual assessment technique. Twenty-eight women had normal menstrual periods at baseline (menstrual score <185) and 32 women had idiopathic menorrhagia (menstrual score > or =185).


RESULTS
Menstrual blood loss scores dropped significantly 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%. In the 32 women with menorrhagic bleeding 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 follow-up, a decrease of 99%. Twenty women developed amenorrhea (33%): 10 in the group of women with normal menstruation and 10 in those women with menorrhagia. Most of the remaining women had oligomenorrhea requiring the use of a few panty-liners only. In one woman, MBL did not decrease, thus requiring further evaluation.


CONCLUSIONS
The impact on MBL of this new 20 mug/day LNG-releasing IUS confirms other studies with devices releasing the same or lower amounts of LNG. The strong endometrial suppression is the principal mechanism explaining the effect on MBL. The strong effect on MBL of this contraceptive method offers an important health benefit and improvement in quality of life, particularly in women with heavy bleeding and anemia, as other treatment modalities are less effective, more costly, more invasive or not readily available.
Wildemeersch
Dirk
D
Contrel Research, Technology Park 3, 9052 Zwijnaarde, Ghent, Belgium. dirk.wildemeersch@contrel.be
Rowe
Patrick J
PJ
D000328:Adult; D001530:Belgium; D016022:Case-Control Studies; D003271:Contraceptive Agents, Female / Q000009:adverse effects*; D005260:Female; D006801:Humans; D007436:Intrauterine Devices, Medicated / Q000009:adverse effects*; D016912:Levonorgestrel / Q000009:adverse effects*; D008595:Menorrhagia / Q000139:chemically induced*; D008598:Menstruation; D008875:Middle Aged
D003271:Contraceptive Agents, Female; D016912:Levonorgestrel