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Emergency Contraception and Body Weight: Pilot Study

NCT02408692 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2017-10-25

Study results available
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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.

Conditions

  • Contraception
  • Body Weight

Interventions

DRUG

ECx1

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.

DRUG

ECx2

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)

Sponsors & Collaborators

  • Medical Research Foundation, Oregon

    collaborator OTHER

  • Oregon Health and Science University

    lead OTHER

Principal Investigators

  • Alison Edelman, MD, MPH · Oregon Health and Science University

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2015-07-31
Completion
2015-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02408692 on ClinicalTrials.gov