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Oral Contraceptive Efficacy and Body Weight

NCT00662454 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2020-09-16

No results posted yet for this study

Summary

The purpose of the blood spot validation portion of the study is to test if measuring female hormone levels in the blood is as accurate through a finger stick, as it is by a blood draw from a vein. The purpose of the feasibility study is to evaluate ovulation occurrence in two populations of oral contraceptive users: heavier and lighter women.

Conditions

  • Contraception
  • Body Weight

Interventions

DRUG

ethinyl estradiol / levonorgestrel

Take one tablet daily of 20 mcg ethinyl estradiol/100 mcg levonorgestrel for 21 days plus 7 days of placebo tablets, repeat for two months total duration.

DRUG

ethinyl estradiol / levonorgestrel

Take one tablet daily of 20 mcg ethinyl estradiol/100 mcg levonorgestrel for 21 days plus 7 days of placebo tablets, repeat for two months total duration.

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • Oregon Clinical and Translational Research Institute

    collaborator OTHER

  • Oregon Health and Science University

    lead OTHER

Principal Investigators

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

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2006-01-31
Primary Completion
2006-05-31
Completion
2006-05-31

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 NCT00662454 on ClinicalTrials.gov