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

Johnson & Johnson (J&J)

Status and phase

Completed

Phase 1

Conditions

Healthy Volunteers

Treatments

Drug: Treatment A: ORTHO EVRA patch (NGMN + EE) with an adhesive overlay

Drug: Treatment B: ORTHO EVRA patch (NGMN + EE) without an overlay

Study type

Interventional

Funder types

Industry

Identifiers

NCT01535820

CR100412

NRGEEPCON1017 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

54 patients

Sex

Female

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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