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Oral Contraceptives and Body Mass Index

NCT01170390 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2015-12-31

Study results available
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Summary

The main hypothesis for this study is that increased Body Mass Index (BMI) alters oral contraceptive metabolism in a manner which results in decreased effectiveness in obese women.

Conditions

  • Body Weight
  • Contraceptive Usage

Interventions

DRUG

All participants (Aviane)

20 mcg EE/0.1 mg LNG cyclically

DRUG

Portia

30 mcg EE/0.15 mg LNG cyclically

DRUG

Aviane

20 mcg EE/0.1 mg LNG continuously dosed

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • Oregon Health and Science University

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2011-03-31
Completion
2011-12-31

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 NCT01170390 on ClinicalTrials.gov