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.

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Authors

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

Abstract

Objective:

To identify an appropriate dose for a new contraceptive levonorgestrel intrauterine system (LNG-IUS).

Design:

Randomized, open-label, three-arm, phase II study.

Setting:

Thirty-seven centers in five European countries.

Patient(s):

Parous or nulliparous women aged 21–40 years.

Intervention(s):

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.

Result(s):

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.

Conclusion(s):

LNG-IUS12 and LNG-IUS16 provided effective contraception, acceptable bleeding patterns, and were well tolerated compared with Mirena.

Read the full text at: http://www.fertstert.org/article/S0015-0282(11)02855-X/fulltext

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Fertility and Sterility® is an international journal for obstetricians, gynecologists, reproductive endocrinologists, urologists, basic scientists and others who treat and investigate problems of infertility and human reproductive disorders. The journal publishes juried original scientific articles in clinical and laboratory research relevant to reproductive endocrinology, urology, andrology, physiology, immunology, genetics, contraception, and menopause. Fertility and Sterility® encourages and supports meaningful basic and clinical research, and facilitates and promotes excellence in professional education, in the field of reproductive medicine.

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