NCT01535820

The Effect of an Adhesive Overlay on the Delivery of Contraceptive Hormones From ORTHO EVRA® in Healthy Women

A Bioequivalence Study to Evaluate the Effect of an Adhesive Overlay on the Delivery of Contraceptive Hormones From ORTHO EVRA® in Healthy Women

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C. · Industry
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the bioequivalence of the contraceptive hormones of ORTHO EVRA when the patch is applied with and without an adhesive overlay.

Detailed description

This is a randomized (the study drug is assigned by chance), open-label (all people know the identity of the intervention), single-center, single-application, 2-way crossover study (participants receive different interventions sequentially during the trial) of ORTHO EVRA with and without an adhesive overlay. ORTHO EVRA is a combination transdermal (through the skin) contraceptive patch containing 6.00 mg of the progestin norelgestromin (NGMN) and 0.75 mg of the estrogen, ethinyl estradiol (EE). The participants will be randomly assigned to 1 of 2 possible treatment sequences to ensure that they receive both of the following treatments, 1 in each period: - Treatment A: ORTHO EVRA patch applied to the buttock with an adhesive overlay applied over the transdermal contraceptive system; - Treatment B: ORTHO EVRA patch applied to the buttock without an overlay. The study consists of a screening phase; an open-label treatment phase consisting of 2 single-application 7-day treatment periods; and end-of-study or withdrawal assessments done upon completion of the 240-hour pharmacokinetic sampling on Day 11 of Period 2 or upon withdrawal. Pharmacokinetic evaluations explore how the drug is absorbed in the body, distributed within the body, and how it is removed from the body over time. The two treatment periods will be separated by a washout period (period when receiving no treatment) of 21 days. During the study, safety and tolerability will also be assessed. The total duration of participation in the study for an individual will be approximately 2 months.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Treatment A: ORTHO EVRA patch (NGMN + EE) with an adhesive overlay	NGMN: type= exact number, unit= mg, number= 6, form= transdermal patch, route= transdermal use. EE: type= exact number, unit= mg, number= 0.75, form= transdermal patch, route= transdermal use. A single patch is applied to the buttock with an adhesive overlay applied over the transdermal contraceptive system for 7 days.
DRUG	Treatment B: ORTHO EVRA patch (NGMN + EE) without an overlay	NGMN: type= exact number, unit= mg, number= 6, form= transdermal patch, route= transdermal use. EE: type= exact number, unit= mg, number= 0.75, form= transdermal patch, route= transdermal use. A single patch is applied to the buttock without an overlay for 7 days.

Timeline

• Start date: 2011-03-01
• Primary completion: 2011-07-01
• Completion: 2011-07-01
• First posted: 2012-02-20
• Last updated: 2013-03-20

Locations

1 site across 1 country: United States