Contraception Clinical Trial
— INTERRUPTOfficial title:
Intervention to End Recurrent Unscheduled Bleeding Trial: A Randomized-controlled Trial of Ulipristal Acetate for Unscheduled Bleeding in Etonogestrel Implant Users
Verified date | August 2018 |
Source | Washington University School of Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 65 |
Est. completion date | January 31, 2018 |
Est. primary completion date | January 31, 2018 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Washington University School of Medicine in St. Louis | Saint Louis | Missouri |
Lead Sponsor | Collaborator |
---|---|
Washington University School of Medicine |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Bleeding/Spotting Days With Use of Ulipristal Acetate as Measured by Daily Bleeding Diaries | To evaluate the effectiveness of ulipristal acetate (15mg) in decreasing bleeding/spotting days due to the ENG implant over a 30-day period as compared to placebo. | 30 days | |
Secondary | Number of Participants With Bleeding Cessation by Day 10 | To evaluate bleeding cessation rates by day 10 following seven days of treatment with either ulipristal acetate or placebo. | 10 days | |
Secondary | Participant Satisfaction With Bleeding Pattern at 30 Days | To evaluate participant satisfaction with regards to bleeding pattern after use of ulipristal acetate. | 30 days | |
Secondary | Number of Participants With Medication Side Effects by 30 Days | To evaluate participant satisfaction with regards to medication side effects. | 30 days | |
Secondary | Ovulation Status Measured by Weekly Serum Progesterone Levels | To evaluate effect, if any, of ulipristal acetate on ovulation status. Data in the table represent the lowest and highest values that were recorded over all of the measurements for each arm as a whole. | Baseline, weeks 1, 2, 3, 4 |
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