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The Pharmacokinetics of 12 Week Continuous Patch Use

NCT02585999 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2017-05-30

Study results available
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Summary

Investigators propose a descriptive pharmacokinetic study of the serum hormone levels of estrogen and progesterone with extended use (12 weeks) of the contraceptive patch. The primary objective is to assess the change in serum ethinyl estradiol (EE2) levels over 12 weeks of continuous contraceptive patch use. The secondary objective is assessing the the norelgestromin (NGMN) levels over the 12 weeks of continuous contraceptive patch use.

Conditions

  • Pharmacokinetics

Interventions

DEVICE

Xulane Contraceptive Patch

Extended use (12 weeks) of contraceptive patch

Sponsors & Collaborators

  • Boston Medical Center

    lead OTHER

Principal Investigators

  • Antonella Lavelanet, DO, JD · Boston Medical Center

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2016-05-31
Completion
2016-06-30
FDA Device
Yes

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 NCT02585999 on ClinicalTrials.gov