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The Pharmacokinetics of 12 Week Continuous Patch Use

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02585999
Recruitment Status : Completed
First Posted : October 26, 2015
Results First Posted : May 30, 2017
Last Update Posted : May 30, 2017
Sponsor:
Information provided by (Responsible Party):
Antonella Lavelanet, Boston Medical Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Pharmacokinetics Device: Xulane Contraceptive Patch Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: The Pharmacokinetics of 12 Week Continuous Patch Use
Study Start Date : October 2015
Actual Primary Completion Date : May 2016
Actual Study Completion Date : June 2016
Arms and Interventions
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Arm Intervention/treatment
Xulane
All participants using the Xulane contraceptive patch for 12 continuous weeks
 Device: Xulane Contraceptive Patch
Extended use (12 weeks) of contraceptive patch
Other Name: Ortho Evra®


Outcome Measures
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Primary Outcome Measures :
  1. Change in Serum EE2 Levels Over 12 Weeks of Continuous Contraceptive Patch Use [ Time Frame: 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 :
  1. NGMN Levels Over 12 Weeks of Continuous Patch Use [ Time Frame: 12 weeks ]
    Liquid chromatography-tandem triple quadrupole mass spectrometry was utilized to assess NGMN


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 39 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02585999


Locations
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United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston Medical Center
Investigators
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Principal Investigator: Antonella Lavelanet, DO, JD Boston Medical Center
More Information
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Responsible Party: Antonella Lavelanet, Physician, Boston Medical Center
ClinicalTrials.gov Identifier: NCT02585999    
Other Study ID Numbers: H-34252
First Posted: October 26, 2015    Key Record Dates
Results First Posted: May 30, 2017
Last Update Posted: May 30, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Antonella Lavelanet, Boston Medical Center:
Hormonal contraception, hormone pharmacokinetics
Additional relevant MeSH terms:
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Contraceptive Agents
Ortho Evra
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptive Agents, Hormonal