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Clinical trial

PK Patch 12 Week Continuous Use

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Last updated:1st Oct 2015

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. Additional objectives include assessing the EE2 area under the curve (AUC) during the study time period, as well as Norelgestromin (NGMN) levels and NGMN AUC over the 12 weeks of continuous contraceptive patch use.


Study Type: Interventional
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: The Pharmacokinetics of 12 Week Continuous Patch Use
Estimated Enrollment: 25
Study Start Date: October 2015
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)

Arms:
- Single arm
(Participants exposed to contraceptive patch, Xulane)

Category Value
Study start date 2015-10-01

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