Pretreatment
with low dose Mifepristone significantly improves the bleeding pattern following
the insertion of the levonorgestrel-releasing intrauterine system with a 52 mg
reservoir (LNG-IUS 52 mg, Mirena®) report the results of randomized control
trial published in Journal of Human Reproduction.
The LNG-IUS
is one of the most cost-effective contraceptive method currently available, but
many women discontinue its use because of irregular bleeding/spotting during
the initial three months following its placement. It is estimated that about
25–62% of women experience irregular vaginal bleeding during the first 3-6
months causing them to discontinue the contraceptive.
With
continued use after 3-6 months, the irregular bleeding and spotting are
reduced, and more than half the women experience amenorrhea at the end of 1
year.
The Swedish
researchers recruited 68 eligible women attending the Karolinska University
Hospital from November 2009-2013 for this prospective, randomized,
double-blind, placebo-controlled trial (European Union Clinical Trials Register–2009-009014-40). Fifty-eight women met the eligibility criteria and were
randomized to receive 50 mg mifepristone as single oral dose or placebo for two
months before and three days following the insertion of LNG-IUS.
The LNG-IUS
insertion was timed at the end of two 28 days menstrual cycle. All women were
asked to systemically note the daily bleeding and spotting (B/S) or adverse
effects for two months of mifepristone treatment and six months following the
insertion of LNG-IUS.
The study
participants underwent routine physical and gynecological examination, required
laboratory tests including pelvic ultrasound, tests for chlamydia infection,
breast biopsy, endometrial biopsy and pap test at baseline and during
follow-up.
After
statistical analysis, researchers noted significant lower B/S in the
mifepristone group (−17.8% points, P < 0.001) in the first month following
the LNG-IUS insertion. However, no significant difference was observed in both
groups in the subsequent months.
This
European study is the first study investigating the effect of prophylactic use
of progesterone receptor modulators to reduce the B/S associated with
post-LNG-IUS insertion. Other studies have investigated mifepristone for
therapeutic purposes.
Based on the
study results, researchers are optimistic that other modified treatment
protocols of mifepristone with different duration and dose could be explored in
further studies. Studies could also be planned with other progesterone receptor
modulators to address the issue of B/S immediately after LNG-IUS insertion.
