Randomized placebo-controlled trial of CDB-2914 in new users of a levonorgestrel-releasing intrauterine system shows only short-lived amelioration of unscheduled bleeding

Human Reproduction
P WarnerH O D Critchley

Abstract

The levonorgestrel-releasing intrauterine system (LNG-IUS) is a highly effective contraceptive. However, during early months of use unscheduled vaginal bleeding is common, sometimes leading to discontinuation. This study aimed to determine whether intermittent administration of progesterone receptor modulator CDB-2914 would suppress unscheduled bleeding during the first 4 months after insertion of the LNG-IUS. CDB-2914 150 mg, in divided doses, or placebo tablets, were administered over three consecutive days starting on Days 21, 49 and 77 after LNG-IUS insertion, in a double-blind randomized controlled trial of women aged 19-49 years, newly starting use of LNG-IUS. Daily bleeding diaries were completed for 6 months, and summarized across blocks as percentage days bleeding/spotting (BS%). Of 69 women randomized to receive CDB-2914, and 67 placebo, 61 and 55, respectively, completed the trial. BS% decreased with time in both arms, but showed a much steeper treatment-phase gradient in the placebo arm (P < 0.0001), so that a benefit of CDB-2914 in the 28 days after first treatment (-11% points, 95% CI -19 to -2), converted to a disadvantage by 64 days after the third treatment (+10% points, 95% CI 1-18). The effect of CDB-2914 on ...Continue Reading

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Citations

Dec 12, 2012·Reviews in Endocrine & Metabolic Disorders·M Hickey, I S Fraser
Mar 15, 2012·Molecular and Cellular Endocrinology·Nathalie Chabbert-BuffetPhilippe Bouchard
Nov 26, 2015·Obstetrics and Gynecology Clinics of North America·EmmaKate Friedlander, Bliss Kaneshiro
Jan 22, 2015·The Journal of Family Planning and Reproductive Health Care·Kumiyo InoueJuliet Richters
Dec 19, 2016·American Journal of Obstetrics and Gynecology·Rachel E Zigler, Colleen McNicholas
Aug 22, 2018·Obstetrics and Gynecology·Rachel E ZiglerColleen McNicholas
Apr 22, 2010·The Journal of Family Planning and Reproductive Health Care·Julia Wilkens, Hilary Critchley
Nov 30, 2019·International Journal of Gynaecology and Obstetrics : the Official Organ of the International Federation of Gynaecology and Obstetrics·Mariana FavaLuis Bahamondes
Nov 26, 2016·The British Journal of General Practice : the Journal of the Royal College of General Practitioners·Joe KaiUNKNOWN ECLIPSE trial collaborative group
Aug 8, 2020·The European Journal of Contraception & Reproductive Health Care : the Official Journal of the European Society of Contraception·P A H H van der HeijdenM Y Bongers

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