Status:
COMPLETED
A Study to Evaluate the Exposure of Norelgestromin and Ethinyl Estradiol From Commercial Lots of EVRA (a Transdermal Contraceptive Patch Manufactured by LOHMANN Therapie-Systeme) and CILEST (an Oral Contraceptive)
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Contraception
Female Contraception
Eligibility:
FEMALE
18-45 years
Phase:
PHASE1
Brief Summary
The objective of this study is to estimate exposure to the hormones norelgestromin, norgestrel, and ethinyl estradiol in healthy female volunteers across multiple commercial lots of EVRA® (a transder...
Detailed Description
This single-center, open-label, randomized, partially-balanced, incomplete block design study will consist of a pre-treatment phase (a screening period lasting up to 21 days), an open-label treatment ...
Eligibility Criteria
Inclusion
- Subjects who are not pregnant (as demonstrated by negative pregnancy tests at screening and before admission for each treatment period) 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 examination), and laboratory test results
- have a history of regular menstrual cycles, weigh at least 110 pounds (50 kilograms), have a body mass index (BMI) between 16 and 29.9 kg per meter squared, a hematocrit of at least 36% at screening, and a ferritin level above the lower limit of normal
- 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 the subject or her male partner are not surgically sterile, agree to continue to use a non-hormone-containing intrauterine device (IUD) or one of the following methods of double-barrier contraception during participation in the study: condoms and foam, diaphragm and gel, or cervical cap and gel.
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 contraindications 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, liver disease, or kidney disease
- currently pregnant or breast feeding, or have evidence of cervical dysplasia (as documented by a Pap smear within 6 months before randomization)
- has used steroid hormonal therapy within 30 days before the first admission visit, received a Depo Provera® injection within 6 months of the first admission visit, received a Lunelle® injection within 60 days before the first admission visit, currently has Norplant® in place, or has had removal of Norplant within the 60 days before the first admission visit, or has used a steroid hormone-containing intrauterine device (IUD) within 3 months of randomization
- has elevated blood pressure (sitting systolic BP \>140 mm Hg and/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 (dermatosis).
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2004
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00258063
Start Date
May 1 2004
End Date
September 1 2004
Last Update
June 8 2011
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