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NCT02863445 · ClinicalTrials.gov registry record · Phase 4
Effectiveness of Orally Dosed Emergency Contraception in Obese Women - LNG
A Phase 4 study, sponsored by Oregon Health and Science University.
- Completed
- Registry status
- Phase 4
- Development phase
- 70
- Enrollment target
NCT02863445: Completed Phase 4 study, sponsored by Oregon Health and Science University.
NCT02863445 is a Phase 4 study that has completed, run by Oregon Health and Science University. The registered enrollment target is 70 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02863445, a Phase 4 study, has completed, sponsored by Oregon Health and Science University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 70 participants
- Enrollment target
Study Summary
Obese women are significantly more likely than their normal BMI counterparts to experience failure of orally-dosed emergency contraceptives. The PI's preliminary data provides evidence for testing a dose escalation strategy in an effort to provide improved efficacy from orally-dosed emergency contraceptives in obese women. The overall project will be focused on both levonorgestrel (LNG) - and ulipristal acetate-containing emergency contraception but this protocol registration is for the LNG aspect of the study procedures.
Primary Outcome
No evidence of follicle rupture achieved by participant in one menstrual (treatment) cycle at 5 days post LNG dosing. Follicle rupture is defined as the disappearance of or \>50% reduction in the size of the leading follicle. Dosing occurred after a dominant follicle measuring 15 mm or greater in at least one dimension was visualized on ultrasound.
Interventions
- DRUG Levonorgestrel-based emergency contraception 1.5 mg
- DRUG Levonorgestrel-based emergency contraception 3.0mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2017-07-06 |
| Est. Completion | 2021-08-16 |
| Phase | Phase 4 |
What the finished NCT02863445 record still lists
NCT02863445 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (86% lower).
The record links to 0 conditions, and to 2 interventions - of which Levonorgestrel-based emergency contraception 1.5 mg is the first listed.
NCT02863445 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02863445 about?
NCT02863445 is a clinical study titled "Effectiveness of Orally Dosed Emergency Contraception in Obese Women - LNG". Obese women are significantly more likely than their normal BMI counterparts to experience failure of orally-dosed emergency contraceptives. The PI's preliminary data provides evidence for testing a dose escalation strategy in an effort to provide improved efficacy from orally-dosed emergency contra...
What is the current status of trial NCT02863445?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 70 participants. The study started on 2017-07-06. Estimated completion is 2021-08-16.
What interventions are being tested in trial NCT02863445?
The interventions under investigation include: Levonorgestrel-based emergency contraception 1.5 mg (DRUG), Levonorgestrel-based emergency contraception 3.0mg (DRUG).
Who is sponsoring clinical trial NCT02863445?
This trial is sponsored by Oregon Health and Science University, which has 546 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02863445's enrollment target sits among peer trials
70 1043rd of 2000 higher than 931 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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