CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 64 enrolled
Drug / intervention
UPA-ECx1 +1 moredrug
Likely dose
UPA-ECx1 30mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02859337
NCT02859337Phase 4Completed
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Improving the Effectiveness of Orally Dosed Emergency Contraceptives in Obese Women - PK and PD of 30mg and 60mg UPA

Oregon Health and Science University·interventional·Posted Aug 9, 2016·Updated Feb 6, 2024

In Brief

A Phase 4 clinical trial evaluating UPA-ECx1 and UPA-ECx2 for Obesity and Contraception. Completed, enrolled 64 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsObesity, Contraception
CountriesUnited States
CollaboratorsNational Institutes of Health (NIH)

Timeline

Phase 4CompletedFinished
2017201820192020202120222023202420252026
First PostedAug 9, 2016
Enrollment StartMay 30, 2017
Primary CompletionJan 13, 2022
Study CompletionNov 15, 2023
TodayJul 2, 2026
Enrollment to primary: 4.6 yearsPosted 9.9 years ago

Interventions

UPA-ECx1drug

Evaluating the pharmacodynamic and pharmacokinetic outcomes in obese women using 30mg of UPA-based EC

UPA-ECx2drug

Evaluating the pharmacodynamic and pharmacokinetic outcomes in obese women using 60mg of UPA-based EC