NCT02585999

The Pharmacokinetics of 12 Week Continuous Patch Use

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Boston Medical Center · Academic / Other
• Sex: Female
• Age: 18 Years – 39 Years
• Healthy volunteers: Accepted

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.

Detailed description

For women who are seeking alternatives to long-acting contraceptives, the oral contraceptive pill and the contraceptive ring are often prescribed in an extended manner (12 weeks straight). The contraceptive patch, however, is not routinely prescribed in this way. Concerns have been raised that hormone levels, in particular estrogen, are higher among patch users than those who use oral contraception or the vaginal ring and that this may contribute to an increased risk of clot. However, few studies have actually looked at these hormone levels in women with extended use of the contraceptive patch. The investigators plan to enroll eligible women age 18-39 who are willing to use the contraceptive patch continuously for twelve weeks, and can adhere to the study requirements for follow-up. All participants will have weekly serum assessments of ethinyl estradiol and norelgestromin levels. The investigators will enroll 30 women, in anticipation of a 33% attrition rate, with the goal of obtaining completed data on 20 participants. The study duration for an individual participant will be 12 weeks and the duration of the entire study will be one year.

Conditions

• Pharmacokinetics

Interventions

Type	Name	Description
DEVICE	Xulane Contraceptive Patch	Extended use (12 weeks) of contraceptive patch

Timeline

• Start date: 2015-10-01
• Primary completion: 2016-05-01
• Completion: 2016-06-01
• First posted: 2015-10-26
• Last updated: 2017-05-30
• Results posted: 2017-05-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study