The Pharmacokinetics of 12 Week Continuous Patch Use

NCT02585999 | Completed Results FDA Device

• 1 other identifier: H-34252
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Pharmacokinetics

Keywords

Hormonal contraception, hormone pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• Change in Serum EE2 Levels Over 12 Weeks of Continuous Contraceptive Patch Use

  Liquid chromatography-tandem triple quadrupole mass spectrometry was utilized to assess EE2

  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

Secondary Outcomes (1)

• NGMN Levels Over 12 Weeks of Continuous Patch Use

  12 weeks

Study Arms (1)

Xulane

OTHER

All participants using the Xulane contraceptive patch for 12 continuous weeks

Device: Xulane Contraceptive Patch

Interventions

Xulane Contraceptive Patch DEVICE

Extended use (12 weeks) of contraceptive patch

Also known as: Ortho Evra®

Xulane

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Medical Center: lead

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Limitations and Caveats

It is difficult to compare our findings with those of previous studies, as previous studies have used other instrumentation and techniques in analysis of EE2. Serum analysis was also performed after all samples were collected from participants.

Results Point of Contact

• Title: Dr. Antonella Lavelanet
• Organization: Boston Medical Center

Katharine.White@bmc.org

6174143745

Study Officials

• Antonella Lavelanet, DO, JD

  Boston Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: October 20, 2015
• First Posted: October 26, 2015
• Study Start: October 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: June 1, 2016
• Last Updated: May 30, 2017
• Results First Posted: May 30, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)