PK Patch 12 Week Continuous Use

Contraception Clinical Trial

Official title:

The Pharmacokinetics of 12 Week Continuous Patch Use

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02585999
• Other study ID #: H-34252
• Status: Active, not recruiting
• Phase: Phase 4
• First received: October 20, 2015
• Last updated: June 13, 2016
• Start date: October 2015
• Est. completion date: July 2016

Study information

• Verified date: June 2016
• Source: Boston Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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. The investigators will enroll 25 women, in anticipation of a 20% 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: July 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 39 Years

Eligibility

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

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Contraception

Intervention

Drug:
• Xulane Contraceptive Patch (generic version of Ortho Evra®*)
Extended use (12 Weeks) of Contraceptive Patch

Locations

Country	Name	City	State
United States	Boston Medical Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in serum EE2 levels over 12 weeks of continuous contraceptive patch use	Liquid chromatography-tandem triple quadruple mass spectrometry will be utilized to assess EE2	12 weeks	Yes
Secondary	NGMN levels over 12 weeks of continuous contraceptive patch use	Liquid chromatography-tandem triple quadruple mass spectrometry will be utilized to assess NGMN	12 weeks	Yes
Secondary	Assessment of side effects and adverse outcomes		12 weeks	Yes