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N/A N=28 Other

The Pharmacokinetics of 12 Week Continuous Patch Use

Pharmacokinetics

Bottom Line

View on ClinicalTrials.gov: NCT02585999 ↗
Enrolled (actual)
28
Serious AEs
0.0%
Results posted
May 2017
Primary outcome: Primary: Change in Serum EE2 Levels Over 12 Weeks of Continuous Contraceptive Patch Use — 12.5; 14.3; 10.9; 42.9 pg/ml

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Xulane Contraceptive Patch (Device)
Age
Adult · 18+ yrs
Sex
Female
Sponsor
Boston Medical Center
Primary completion
May 2016

Outcome Measures

OutcomeResultp-value
PRIMARY
Change in Serum EE2 Levels Over 12 Weeks of Continuous Contraceptive Patch Use		 12.5; 14.3; 10.9; 42.9; 25.9; 34.1 —
SECONDARY
NGMN Levels Over 12 Weeks of Continuous Patch Use		 0.691; 0.699; 0.674; 1.09; 0.746; 0.877 —

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.

Eligibility Criteria

Inclusion Criteria

  • Willing and able to come to the clinic to have blood drawn weekly for 12 weeks, biweekly during weeks 4, 8, and 12, and for 3 days after the final patch is removed for blood draws for a total of 18 blood draws
  • Willing and able to abstain from using any other hormonal contraceptive method while in the study and for the week prior to starting the study

Exclusion Criteria

  • Body Mass Index greater than 35
  • Personal or Family History of Venothromboembolism
  • Personal History of Migraines with Aura
  • Personal History of Migraines without Aura
  • Tobacco use greater than or equal to 15 cigarettes per day
  • Current Pregnancy
  • History of or Current Diagnosis of Cancer
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02585999). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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