The Effect of an Adhesive Overlay on the Delivery of Contraceptive Hormones From ORTHO EVRA® in Healthy Women
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

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.
    

Intervention name(s): Treatment A: ORTHO EVRA patch (NGMN + EE) with an adhesive overlay; Treatment B: ORTHO EVRA patch (NGMN + EE) without an overlay
Intervention type(s): Drug; Drug
Intervention description(s): 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.; 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.
Intervention MeSH terms: Ortho Evra
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy volunteers; ORTHO EVRA; Contraceptive hormones; Transdermal patch; Progestin norelgestromin (NGMN); Estrogen ethinyl estradiol (EE); JNJ-93964; JNJ-622206