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

• Status: Completed
• Trial end date: 2011-07-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Treatments: Contraceptive Agents; Hormones; Ortho Evra

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