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

Condition(s) targeted: Healthy Volunteers

Intervention: Treatment A: ORTHO EVRA patch (NGMN + EE) with an adhesive overlay (Drug); Treatment B: ORTHO EVRA patch (NGMN + EE) without an overlay (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Official(s) and/or principal investigator(s):
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Clinical Trial, Study Director, Affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

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.

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

Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

NGMN plasma concentrations (Periods 1 and 2)

EE plasma concentrations (Periods 1 and 2)

Secondary outcome:

Pharmacokinetic parameters of NGMN (Periods 1 and 2)

Pharmacokinetic parameters of EE (Periods 1 and 2)

Incidence of adverse events as a measure of safety and tolerability

The number of patients with changes in clinical laboratory test values, physical examination results, and vital signs measurements

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.

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Female.

Criteria:

Inclusion Criteria:

- Signed informed consent

- Body mass index (BMI) between 18 and 30 kg/m2 (inclusive), and body weight not less

than 50 kg and not more than 90 kg

- Must be surgically sterile with intact ovaries, abstinent, or, if sexually active, be

practicing an effective method of non-hormonal birth control (eg, non-hormonal intrauterine device, double-barrier method, male partner sterilization) before entry and throughout the study

- Completed her last term pregnancy at least 90 days before admission to the study site

- History of regular menstrual cycles (occurring every 25 to 35 days)

- Must not be pregnant or lactating

- Blood pressure between 90 and 140 mmHg systolic (inclusive), and no higher than 90

mmHg diastolic

- Hemoglobin equal or more than 12. 0 at screening

Exclusion Criteria:

- History of smoking or use of nicotine-containing substances

- Used steroid hormonal therapy within 30 days before admission to the study

- Received a Depo Provera® injection in the 6 months before admission to the study

- History or presence of disorders commonly accepted as contraindications to sex

hormonal therapy

- History of or current clinically significant medical illness or any other condition

that the investigator considers should exclude the patient or that could interfere with the interpretation of the study results

Neptune, New Jersey, United States

Starting date: March 2011
Last updated: March 19, 2013