A Comparative Pharmacokinetic Study of ORTHO EVRA (a Transdermal Contraceptive Patch) and CILEST (an Oral Contraceptive) in Healthy Female Volunteers

• Status: Completed
• Trial end date: 2003-03-01
• Target enrollment: 0
• Participant gender: Female

Summary

The objective of this study is to compare the levels of the hormones norelgestromin, norgestrel, and ethinyl estradiol in the bloodstream of healthy female volunteers administered ORTHO EVRA® (a transdermal contraceptive patch) and CILEST® (an oral contraceptive). The open-label treatment phase of the study consists of two 28-day cycles of one treatment, a washout period of 28 days, and crossover to two 28-day cycles of the other treatment.

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

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Treatments: Contraceptive Agents; Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol valerate; Ethinyl Estradiol; Norelgestromin; Norgestimate, ethinyl estradiol drug combination; Polyestradiol phosphate

Criteria

Inclusion Criteria:

• Subjects who are not pregnant (as demonstrated by pregnancy tests at screening and admission) or breast feeding, and who have completed their last term pregnancy at least 60 days before the admission visit

• confirmed to be in good health as determined by medical history, physical examination (including vital signs), gynecologic examination (including breast and pelvic exam), laboratory test results, and the absence of evidence of cervical dysplasia (as documented by a Pap smear within 6 months before dosing)

• have a history of regular menstrual cycles, weigh at least 121 pounds (55 kilograms), have a body mass index (BMI) between 18.0 and 29.9 kg per meter squared, and a hematocrit of at least 36%

• are nonsmokers and have not used any tobacco products for at least 6 months before study admission

• Agree not to use any prescription or nonprescription medications for the duration of the study, and if not surgically sterile, agree to use spermicide and barrier contraception, or a nonsteroid-containing intrauterine device as a method of contraception during participation in the study

Exclusion Criteria:

• Subjects with a history or presence of disorders commonly accepted as contraindications to sex hormonal therapy including, but not limited to: deep vein thrombophlebitis or thromboembolic disorders, cerebral vascular or coronary artery disease, chronic untreated hypertension or migraines, benign or malignant liver tumor which developed during the use of oral contraceptives or other estrogen-containing products, or known or suspected estrogen-dependent neoplasia

• presence of disorders commonly accepted as a contraindication to combined oral contraceptive therapy including, but not limited to: undiagnosed abnormal vaginal bleeding, any neurovascular lesion of the eye or serious visual disturbance, any impairment of liver function or liver disease, or kidney disease

• recent history (within 12 months before the admission visit) of alcohol or other substance abuse

• has used steroid-hormonal therapy within 30 days before study admission, received a Depo Provera® injection within 6 months of study admission, currently has Norplant® in place, or has had removal of Norplant within the 60 days before study admission, has used a steroid hormone-containing intra-uterine device (IUD) within 3 months before study admission

• has elevated blood pressure (sitting systolic BP >140 mm Hg or diastolic BP >90 mm Hg)

• has a history or presence of hypersensitivity in response to topical applications (bandages, surgical tape, etc.) or has active inflammation of the skin (dermatitis) or other skin conditions (dermatoses).