The Pharmacokinetics of 12 Week Continuous Patch Use

Not Applicable

Completed

• Conditions: Pharmacokinetics
• Interventions: Device: Xulane Contraceptive Patch

• Registration Number: NCT02585999
• Lead Sponsor: Boston Medical Center

Brief 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.

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2015-10-20
• Study First Submitted QC: 2015-10-23
• Study First Posted: 2015-10-26
• Primary Completion: 2016-05
• Study Completion: 2016-06
• Results First Submitted: 2016-06-30
• Status Verified: 2017-04
• Results First Submitted QC: 2017-04-17
• Last Update Submitted: 2017-04-17
• Results First Posted: 2017-05-30
• Last Update Posted: 2017-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Xulane	Xulane Contraceptive Patch	All participants using the Xulane contraceptive patch for 12 continuous weeks

Primary Outcome Measures

Name	Time	Method
Change in Serum EE2 Levels Over 12 Weeks of Continuous Contraceptive Patch Use	Total of 18 blood draws - once at the end of each patch week and two times during weeks four, eight and twelve (with the additional blood draw occurring mid-week); and blood draws performed for three continuous days after the final patch was removed	Liquid chromatography-tandem triple quadrupole mass spectrometry was utilized to assess EE2

Secondary Outcome Measures

Name	Time	Method
NGMN Levels Over 12 Weeks of Continuous Patch Use	12 weeks	Liquid chromatography-tandem triple quadrupole mass spectrometry was utilized to assess NGMN

Trial Locations

Locations (1)

Boston Medical Center; 🇺🇸 Boston, Massachusetts, United States