A randomized, phase II study describing the efficacy, bleeding profile, and safety of two low-dose levonorgestrel-releasing intrauterine contraceptive systems and Mirena
Two new low-dose LNG-IUSs provided effective contraception with a similar bleeding profile to Mirena and were significantly easier and less painful to place compared with Mirena.
Kristina Gemzell-Danielsson, M.D., Ph.D., Ilka Schellschmidt, M.D., Dan Apter, M.D., Ph.D.
Volume 97, Issue 3 , Pages 616-622.e3, March 2012
To identify an appropriate dose for a new contraceptive levonorgestrel intrauterine system (LNG-IUS).
Randomized, open-label, three-arm, phase II study.
Thirty-seven centers in five European countries.
Parous or nulliparous women aged 21–40 years.
Treatment with LNG-IUSs with initial in vitro release rates of 12 or 16 μg/d (LNG-IUS12/16) or 20 μg/d (Mirena).
Main Outcome Measure(s):
Pearl index, bleeding profile, ease/pain of placement/removal, adverse events.
A total of 738 subjects had an LNG-IUS placed (LNG-IUS12, n = 239; LNG-IUS16, n = 245; Mirena, n = 254). One, 5, and 0 pregnancies occurred in the LNG-IUS12, LNG-IUS16, and Mirena groups, respectively (3-year unadjusted Pearl indices: 0.17, 0.82, and 0). The bleeding profiles were similar in all groups, although total bleeding and spotting days decreased with increasing LNG dose. During 3 years, 10 subjects in the LNG-IUS12 (2 women), LNG-IUS16 (3 women), and Mirena (5 women) groups reported serious adverse events, possibly related to study treatment. Placement of LNG-IUS12 and LNG-IUS16 was considered easy in 94% versus 86.2% in the Mirena group and 72.3% in the LNG-IUS12/LNG-IUS16 group reported either “no pain” or only “mild pain” during placement versus 57.9% in the Mirena group.
LNG-IUS12 and LNG-IUS16 provided effective contraception, acceptable bleeding patterns, and were well tolerated compared with Mirena.