At a glance

ClinicalIndex Comparison Record

Phase 4Completed· 34 enrolled

Drug / intervention

LNG-EC +1 moredrug

Likely dose

LNG-EC 1.5mgfrom 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/NCT02689804

NCT02689804Phase 4Completed

Compare CT.gov

Pharmacokinetics of Levonorgestrel and Ulipristal Acetate Emergency Contraception in Women With Normal and Obese Body Mass Index

Columbia University·interventional·Posted Feb 24, 2016·Updated Jul 7, 2017

In Brief

A Phase 4 clinical trial evaluating LNG-EC and UPA-EC for Contraception. Completed, enrolled 34 participants across 1 site.

Detailed Summary

A well-designed pharmacokinetics (PK) study may identify the physiologic basis for observed differences in levonorgestrel emergency contraception (LNG-EC) and ulipristal acetate emergency contraception (UPA-EC) failure rates in women with normal and obese BMI. The investigators propose a study to compare serum LNG and UPA levels after administration of a single-dose of LNG-EC or UPA-EC. The investigators hypothesize that there will be no difference in PK parameters between women with normal BMI and obese women.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsContraception

CountriesUnited States

Collaborators--

Timeline

Phase 4CompletedFinished

20162017201820192020202120222023202420252026

Enrollment StartJul 2015

Primary CompletionDec 2015

First PostedFeb 2016

Study CompletionFeb 2017

TodayJul 2026

First PostedFeb 24, 2016

Enrollment StartJul 10, 2015

Primary CompletionDec 29, 2015

Study CompletionFeb 3, 2017

TodayJul 2, 2026

Enrollment to primary: 6 monthsPosted 10.4 years ago

Interventions

LNG-ECdrug

FDA-approved emergency contraceptive pill containing levonorgestrel 1.5mg

UPA-ECdrug

FDA-approved emergency contraceptive pill containing ulipristal acetate 30mg