A randomized controlled trial of treatment options for troublesome uterine bleeding in Implanon users
Open Access
- 15 April 2009
- journal article
- research article
- Published by Oxford University Press (OUP) in Human Reproduction
- Vol. 24 (8), 1852-1861
- https://doi.org/10.1093/humrep/dep081
Abstract
Pilot data have indicated that both doxycycline alone and mifepristone combined with ethinyl estradiol (EE) are effective in stopping episodes of bleeding in Implanon users with troublesome bleeding. We compared four treatments against a placebo in Implanon users and tested whether repeated treatment improved subsequent bleeding patterns. Implanon users aged 18–45 years were randomized to treatment with (i) mifepristone 25 mg given twice on day 1 followed by 4 days of EE 20 µg; (ii) doxycycline 100 mg twice daily for 5 days; (iii) mifepristone 25 mg given twice on day 1 plus doxycycline 100 mg twice daily for 5 days; (iv) doxycycline 100 mg twice daily with EE 20 µg daily; and (v) placebo twice daily for 5 days. The primary end-point was the number of days of bleeding/spotting immediately following initiation of the first 5-day course of each therapy, compared with placebo. There were 204 women assigned to treatment. Mifepristone in combination with either EE or doxycycline was significantly more effective in stopping an episode of bleeding (mean 4.0 days (CI 3.5–4.6) and 4.4 days (CI 3.8–5.2), respectively) than doxycycline alone or in combination with EE, or placebo (6.4 days (CI 4.4–9.2), 6.4 days (CI 4.8–8.6) and 6.4 days (CL 5.1–8.0), respectively). Mifepristone combined with either EE or doxycycline was significantly more effective than placebo in terminating an episode of bleeding in Implanon users. However there was no improvement in subsequent bleeding patterns. Trial registration number: ACTR # 012605000206628.Keywords
This publication has 17 references indexed in Scilit:
- Stimulation of epithelial repair is a likely mechanism for the action of mifepristone in reducing duration of bleeding in users of progestogen-only contraceptivesReproduction, 2008
- The effects of Implanon® on menstrual bleeding patternsThe European Journal of Contraception & Reproductive Health Care, 2008
- Treatment of vaginal bleeding irregularities induced by progestin only contraceptives.Published by Wiley ,2007
- The long-term actions of etonogestrel and levonorgestrel on decidualized and non-decidualized endometrium in a mouse model mimic some effects of progestogen-only contraceptives in womenReproduction, 2007
- A pilot study to assess the effect of three short-term treatments on frequent and/or prolonged bleeding compared to placebo in women using ImplanonHuman Reproduction, 2006
- Effect of intermittent treatment with mifepristone on bleeding patterns in Norplant® implant usersContraception, 2004
- Mechanisms of abnormal uterine bleeding.Human Reproduction Update, 2002
- Superficial endometrial vascular fragility in Norplant users and in women with ovulatory dysfunctional uterine bleedingHuman Reproduction, 2000
- Menstrual bleeding patterns in untreated womenContraception, 1997
- Cold hypersensitivityArchives of Internal Medicine, 1974