Intervention to End Recurrent Unscheduled Bleeding Trial

NCT03118297 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: 201612002
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Contraception; Bleeding

Keywords

Etonogestrel Implant

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Number of Participants With Bleeding Cessation by Day 10

  10 days

• Participant Satisfaction With Bleeding Pattern at 30 Days

  30 days

• Number of Participants With Medication Side Effects by 30 Days

  30 days

• Ovulation Status Measured by Weekly Serum Progesterone Levels

  Baseline, weeks 1, 2, 3, 4

Study Arms (2)

Ulipristal Acetate

EXPERIMENTAL

15mg ulipristal acetate (capsule) daily for 7 days

Drug: Ulipristal Acetate

Placebo

PLACEBO COMPARATOR

Identical placebo (capsule) daily for 7 days

Drug: Placebo oral capsule

Interventions

Ulipristal Acetate DRUG

Women who have bothersome bleeding with the etonogestrel implant will be randomized to receive ulipristal acetate versus placebo daily for 7 days.

Ulipristal Acetate

Placebo oral capsule DRUG

Women who have bothersome bleeding with the etonogestrel implant will be randomized to receive ulipristal acetate versus placebo daily for 7 days.

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine in St. Louis

St Louis, Missouri, 63110, United States

Location

Related Publications (1)

• Zigler RE, Madden T, Ashby C, Wan L, McNicholas C. Ulipristal Acetate for Unscheduled Bleeding in Etonogestrel Implant Users: A Randomized Controlled Trial. Obstet Gynecol. 2018 Oct;132(4):888-894. doi: 10.1097/AOG.0000000000002810.

  PMID: 30130351 DERIVED

MeSH Terms

Conditions

Hemorrhage

Interventions

ulipristal acetate

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Intervention To End Recurrent Unscheduled bleeding Trial (INTERRUPT): A randomized-controlled trial
• Organization: WashingtonU

rachelezig@gmail.com

3143228697

Study Officials

• Rachel Zigler, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Fellow

Study Record Dates

• First Submitted: April 4, 2017
• First Posted: April 18, 2017
• Study Start: May 1, 2017
• Primary Completion: January 31, 2018
• Study Completion: January 31, 2018
• Last Updated: August 31, 2018
• Results First Posted: August 31, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)