Phase 3
N=65
Intervention to End Recurrent Unscheduled Bleeding Trial
Contraception · Bleeding
Bottom Line
View on ClinicalTrials.gov: NCT03118297 ↗Enrolled (actual)
65
Serious AEs
0.0%
Results posted
Aug 2018
Primary outcome: Primary: Number of Bleeding/Spotting Days With Use of Ulipristal Acetate as Measured by Daily Bleeding Diaries — 7; 12 days — p=0.002
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Ulipristal Acetate (Drug); Placebo oral capsule (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Washington University School of Medicine
- Primary completion
- Jan 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Bleeding/Spotting Days With Use of Ulipristal Acetate as Measured by Daily Bleeding Diaries |
7; 12 | 0.002 sig |
| SECONDARY Number of Participants With Bleeding Cessation by Day 10 |
11; 3 | 0.032 sig |
| SECONDARY Participant Satisfaction With Bleeding Pattern at 30 Days |
0; 7; 0; 2; 4; 3 | <0.001 sig |
| SECONDARY Number of Participants With Medication Side Effects by 30 Days |
3; 6; 1; 3; 0; 1 | >0.05 |
| SECONDARY Ovulation Status Measured by Weekly Serum Progesterone Levels |
0.0; 0.0; 4.4; 1.3 | — |
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
- 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
Data sourced from ClinicalTrials.gov (NCT03118297). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.