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

NCT00254865 | Completed Phase 1

• 1 other identifier: CR003007
• Study Type: interventional
• Target: 34
• Locations: 0 countries
• Sites: N/A

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 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.

Conditions

Contraception; Female Contraception

Keywords

Transdermal contraception; contraceptive; hormonal, steroid contraception; ethinyl estradiol; progesterone; EVRA; CILEST

Outcome Measures

Primary Outcomes (1)

• A comparison of the total exposure and pharmacokinetics, over comparable time intervals (Week 1 of Cycle 1 and Week 3 of Cycle 2), of NGMN, NG, and EE for ORTHO EVRA® and CILEST®.

Secondary Outcomes (1)

• Pharmacodynamic measurements [sex hormone-binding globulin (SHBG), corticosteroid binding globulin (CBG), and corticosteroid-binding globulin binding capacity (CBG-BC)] during pre-treatment, Cycle 1, Washout and Cycle 2.

Interventions

EVRA® transdermal contraceptive patch containing 6 mg of norelgestromin and 0.75 mg of ethinyl estradiol (versus CILEST® tablets). DRUG

Eligibility Criteria

• Age: 18 Years - 48 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: lead

Related Links

• A comparative pharmacokinetic study of EVRA� (a transdermal contraceptive patch) and CILEST� (an oral contraceptive) in healthy female volunteers

MeSH Terms

Interventions

norelgestromin; Ethinyl Estradiol

Intervention Hierarchy (Ancestors)

Norpregnatrienes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estrogenic Steroids, Alkylated; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

  Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 15, 2005
• First Posted: November 17, 2005
• Study Start: August 1, 2002
• Study Completion: March 1, 2003
• Last Updated: June 8, 2011

Record last verified: 2011-01