CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 10 enrolled
Drug / intervention
ECx1 +1 moredrug
Likely dose
ECx1 1.5 mgfrom 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/NCT02408692
NCT02408692Phase 4Completed
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Emergency Contraception and Body Weight: Pilot Study

Oregon Health and Science University·interventional·Posted Apr 3, 2015·Updated Oct 25, 2017

In Brief

A Phase 4 clinical trial evaluating ECx1 and ECx2 for Contraception and Body Weight. Completed, enrolled 10 participants across 1 site.

Detailed Summary

The purpose of this research study is to determine how body weight changes the drug level of an emergency contraceptive pill containing a hormone called levonorgestrel (LNG). This emergency contraceptive is available to women without a prescription, but has recently been found to not work as well to prevent pregnancies in women of higher body weight. The overall goal of this research is to improve the effectiveness of contraception for women, no matter their weight.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsContraception, Body Weight
CountriesUnited States
CollaboratorsMedical Research Foundation, Oregon

Timeline

Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
First PostedApr 3, 2015
Enrollment StartFeb 1, 2015
Primary CompletionJul 1, 2015
Study CompletionAug 1, 2015
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 11.2 years ago

Interventions

ECx1drug

At the first treatment visit, all women will be given the study drug (1.5 mg of levonorgestrel) and several blood samples will be taken over 2.5 hours). After this visit, women with a BMI of \<25 kg/m2 will have completed study participation.

ECx2drug

At the first treatment visit, all women will be given the study drug (1.5 mg of levonorgestrel) and several blood samples will be taken over 2.5 hours). For women with a BMI of 30kg/m2 and greater, one additional visit will be required and study drug (3 mg of levonorgestrel) will be given and several blood samples will be taken over 2.5 hours)