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NCT02859337 · ClinicalTrials.gov registry record · Phase 4

Effectiveness of Orally Dosed Emergency Contraception in Obese Women - UPA

A Phase 4 study, sponsored by Oregon Health and Science University.

Completed
Registry status
Phase 4
Development phase
64
Enrollment target

NCT02859337: Completed Phase 4 study, sponsored by Oregon Health and Science University.

NCT02859337 is a Phase 4 study that has completed, run by Oregon Health and Science University. The registered enrollment target is 64 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02859337, a Phase 4 study, has completed, sponsored by Oregon Health and Science University.

COMPLETED
Registry status
Phase 4
Development phase
64 participants
Enrollment target

Study Summary

Obese women are significantly more likely than their normal BMI counterparts to experience failure of orally-dosed emergency contraceptives. Our 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. More data is needed regarding emergency contraception containing ulipristal acetate. The overall project will be focused on both levonorgestrel (LNG) - and ulipristal acetate (UPA)-containing emergency contraception but this protocol registration is for the UPA aspect of the study procedures.

Primary Outcome

Follicular rupture (yes/no) beyond 5 days from EC dosing by ultrasound in participants with a BMI \>/=30 kg/m2. The comparison is between menstrual cycles where 30 versus 60 mg of UPA was taken. Follicular rupture is defined as the disappearance of or \>50% reduction in size of the leading follicle. The day of EC dosing is defined as day zero.

Interventions

  • DRUG UPA-ECx1
  • DRUG UPA-ECx2

Trial Details

FieldValue
Enrollment Target 64 participants
Start Date 2017-05-30
Est. Completion 2023-11-15
Phase Phase 4

What the finished NCT02859337 record still lists

NCT02859337 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 64 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (88% lower).

The record links to 0 conditions, and to 2 interventions - of which UPA-ECx1 is the first listed.

NCT02859337 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02859337 about?

NCT02859337 is a clinical study titled "Effectiveness of Orally Dosed Emergency Contraception in Obese Women - UPA". Obese women are significantly more likely than their normal BMI counterparts to experience failure of orally-dosed emergency contraceptives. Our preliminary data provides evidence for testing a dose escalation strategy in an effort to provide improved efficacy from orally-dosed emergency contracepti...

What is the current status of trial NCT02859337?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 64 participants. The study started on 2017-05-30. Estimated completion is 2023-11-15.

What interventions are being tested in trial NCT02859337?

The interventions under investigation include: UPA-ECx1 (DRUG), UPA-ECx2 (DRUG).

Who is sponsoring clinical trial NCT02859337?

This trial is sponsored by Oregon Health and Science University, which has 546 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02859337's enrollment target sits among peer trials

64 1098th of 2000 higher than 895 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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Source: ClinicalTrials.gov NCT02859337, the US trial registry maintained by the National Library of Medicine. NCT02859337 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.