A Study to Evaluate the Hormone Exposure From Multiple Commercial Lots of ORTHO EVRA (a Transdermal Contraceptive Patch)
Condition: Contraception; Female Contraception
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to estimate the exposure to the hormones norelgestromin,
      norgestrel, and ethinyl estradiol in the bloodstream of healthy female volunteers across
      multiple commercial lots of ORTHO EVRAÂ® (a transdermal contraceptive patch) and to compare
      these data to historical hormonal exposure data from one ORTHO EVRAÂ® clinical development
      lot.
    

Detailed description: 
      This multicenter, open-label, randomized, partially-balanced, incomplete block design study
      will consist of a pre-treatment phase (a screening period lasting up to 21 days), an
      open-label treatment phase (three 7-day treatment periods separated by 21-day washouts), and
      a post-treatment phase (a follow-up or early withdrawal visit). Total participation in the
      study is approximately 67 days. Approximately 52 subjects will be enrolled. The study
      population comprises healthy women, ages 18 to 45 years inclusive, who weigh at least 110
      pounds, have a body mass index (BMI) between 16 and 29.9 kg per meter squared.

      An ORTHO EVRA® patch from 1 of the 13 selected commercial lots will be applied to the buttock
      of each subject and worn for 7 days. Patches will be applied on Days 1, 29, and 57 by the
      investigator or designated study unit personnel. Each patch will be worn on the upper outer
      quadrant of the same buttock, but the 3 patches will not necessarily be placed in the exact
      same position. The investigator or designated study unit personnel will remove the patches on
      Days 8, 36, and 64 and will evaluate the adhesion of the patches before removal.

      Subjects will be confined to the study unit for blood sample collections for determination of
      NGMN, NG, and EE serum concentrations. Blood samples will be collected (via venipuncture)
      immediately before and at specified time points after each patch application. Pharmacokinetic
      parameters of NGMN, NG, and EE, including Cmax, tmax, and AUC for each treatment will be
      estimated by standard methods. Safety will be assessed throughout the study, and will be
      based on adverse events and changes in physical and gynecologic examinations (including
      breast examinations), vital signs, electrocardiograms (ECGs), and clinical laboratory test
      results. Three 7-day treatment periods, separated by 21-day washouts, as follows: Each ORTHO
      EVRA® patch will be worn on the buttock (upper outer quadrant) for 7 days. Twenty one days
      after completing each treatment, subjects will cross over to the next treatment for 7 days.
      The patch will be applied to the upper outer quadrant of the same buttock as before, but not
      necessarily in the exact same spot.
    

Intervention name(s): EVRA transdermal contraceptive patch 6 mg NGMN and 0.75 mg EE
Intervention type(s): Drug
Intervention MeSH terms: Contraceptive Agents
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Transdermal contraception; contraceptive; hormonal, steroid contraception; ethinyl estradiol; progesterone; EVRA