Intervention to End Recurrent Unscheduled Bleeding Trial
Status:
Completed
Trial end date:
2018-01-31
Target enrollment:
Participant gender:
Summary
The subdermal etonogestrel (ENG) implant, a long-acting reversible contraceptive (LARC)
method, is among the most effective forms of reversible contraception and thus, an important
tool in the quest to reduce unintended pregnancy. However, despite overall increases in LARC
use in the United States from 1.5% in 2002 to 7.2% in 2011, and 11.6% most recently in 2015,
implant use continues to make up a small proportion of LARC use. While evidence to explain
this low uptake of implants is lacking, one potential reason is patient and provider concerns
about unpredictable bleeding.
As a result of this, many studies have been performed in attempts to discover therapies for
unscheduled bleeding in progestin-only contraceptive users. Some of these studies include
those investigating selective progesterone receptor modulators, such as mifepristone and
ulipristal acetate (UPA), which did find some benefit. Although a previous study showed mixed
benefit, the investigators feel that this medication has demonstrated both biologic
plausibility as well as clinically important outcomes. This previous study may not be
entirely translatable to the proposed research as therapies were used for different
indications (prophylaxis vs. treatment) and different progestins and delivery systems were
studied. Therefore, the investigators believe UPA should not be discounted as a potential
therapy. UPA may provide an additional safe and effective option for treatment of irregular
bleeding with implants in women. In addition, UPA is currently available in outpatient
pharmacies in the U.S. as a single 30mg oral tablet.
The investigators propose to investigate UPA for the treatment of unscheduled and troublesome
bleeding in ENG implant users.