Status:
COMPLETED
A Comparative Pharmacokinetic Study of ORTHO EVRA (a Transdermal Contraceptive Patch) and CILEST (an Oral Contraceptive) in Healthy Female Volunteers
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Contraception
Female Contraception
Eligibility:
FEMALE
18-48 years
Phase:
PHASE1
Brief 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 tran...
Detailed Description
ORTHO EVRA® is a combination, monophasic transdermal contraceptive patch containing 6 mg of norelgestromin (NGMN) and 0.75 mg of ethinyl estradiol (EE), and delivering to the systemic circulation an a...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
August 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2003
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT00254865
Start Date
August 1 2002
End Date
March 1 2003
Last Update
June 8 2011
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.