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Progestin
Levonorgestrel-based emergency contraception 3.0mg for Obesity (EC-Obesity Trial)
Phase 4
Waitlist Available
Led By Alison Edelman, MD, MPH
Research Sponsored by Oregon Health and Science University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 days
Awards & highlights
EC-Obesity Trial Summary
This trial is testing a new dose of emergency contraception for obese women, who are more likely to experience failure with the current dose.
Eligible Conditions
- Obesity
EC-Obesity Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The Number of Participants in Two Treatment Groups (1.5mg Levonorgestrel and 3mg Levonorgestrel) With no Follicle Rupture at 5 Days Within One Menstrual (Treatment) Cycle.
Secondary outcome measures
Number of Participants With Follicle Rupture Before 5 Days
Side effects data
From 2021 Phase 4 trial • 70 Patients • NCT028634459%
Upper Respiratory Infection
9%
Nausea
6%
Menstrual Cramping
6%
Abdominal Cramping
6%
Common Cold
3%
Headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
LNG-ECx1
LNG-ECx2
EC-Obesity Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: LNG-ECx2Experimental Treatment1 Intervention
Levonorgestrel 3mg orally x 1 dose. Timing of dosage depends on ovarian follicle measurements.
Group II: LNG-ECx1Active Control1 Intervention
Levonorgestrel 1.5 mg orally x 1 dose. Timing of dosage depends on ovarian follicle measurements.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Levonorgestrel-based emergency contraception 3.0mg
2017
Completed Phase 4
~70
Find a Location
Who is running the clinical trial?
Oregon Health and Science UniversityLead Sponsor
973 Previous Clinical Trials
6,845,959 Total Patients Enrolled
29 Trials studying Obesity
9,276 Patients Enrolled for Obesity
National Institutes of Health (NIH)NIH
2,696 Previous Clinical Trials
6,952,509 Total Patients Enrolled
103 Trials studying Obesity
25,786 Patients Enrolled for Obesity
Alison Edelman, MD, MPHPrincipal InvestigatorOregon Health and Science University
7 Previous Clinical Trials
314 Total Patients Enrolled
Frequently Asked Questions
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