Intervention to End Recurrent Unscheduled Bleeding Trial
Condition: Contraception; Bleeding
MeSH terms: Hemorrhage
Intervention: Ulipristal Acetate; Placebo oral capsule
Intervention description: Women who have bothersome bleeding with the etonogestrel implant will be randomized to receive ulipristal acetate versus placebo daily for 7 days.; Women who have bothersome bleeding with the etonogestrel implant will be randomized to receive ulipristal acetate versus placebo daily for 7 days.
Intervention MeSH terms: Ulipristal acetate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 65.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: Etonogestrel Implant

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women age 18-45

          -  Implant placed >90 days and <3 years prior to enrollment

          -  Patient complaint of bothersome irregular bleeding with implant

          -  Willing to be abstinent or use condoms during study period

          -  Willing to complete 30-day bleeding diary

          -  Willing to be randomized to placebo or ulipristal acetate

          -  Ability to send/receive SMS text message

        Exclusion Criteria:

          -  Non-English speaking

          -  Implant placed >3 years prior to enrollment

          -  Contraindication to ulipristal acetate (current use of barbiturates, bosentan,
             carbamazepine, felbamate, griseofulvin, oxcarbazepine, phenytoin, rifampin, St. John's
             Wort, topiramate, known or suspected pregnancy, hypersensitivity to active substance
             or excipients, uterine/cervical/ovarian/breast cancer, severe asthma insufficiently
             controlled by oral glucocorticoids)

          -  Inability or unwillingness to comply with medication protocol

          -  Inability or unwillingness to comply with bleeding diary

          -  Breastfeeding