PK Patch 12 Week Continuous Use

• Status: Active, not recruiting
• Trial end date: 0000-00-00
• Target enrollment: 30
• Participant gender: Female

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. 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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Boston Medical Center
• Treatments: Contraceptive Agents; Ortho Evra
• Last Updated: 2016-06-13

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