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Sponsored by: |
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
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Information provided by: | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
ClinicalTrials.gov Identifier: | NCT00258063 |
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 transdermal contraceptive patch manufactured by LOHMANN Therapie-Systeme), to compare these data to exposure data from one clinical lot, and to compare these data to exposure data from a commercially available oral contraceptive.
Condition | Intervention | Phase |
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Contraception Female Contraception |
Drug: EVRA® transdermal contraceptive patch containing 6 mg of norelgestromin and 0.60 mg of ethinyl estradiol (versus CILEST® tablets). |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Uncontrolled, Crossover Assignment, Pharmacokinetics Study |
Official Title: | Open-Label, Randomized, Partially Balanced, Incomplete Block Design Study to Evaluate the Hormone Exposure From Commercial EVRA® (Manufactured by LOHMANN Therapie-Systeme) and an Oral Contraceptive |
Estimated Enrollment: | 54 |
Study Start Date: | May 2004 |
Estimated Study Completion Date: | September 2004 |
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 phase (three 7-day treatment periods separated by 21-day washouts), and a post-treatment phase (a follow-up or early withdrawal visit). Total participation in the study is approximately 67 days. Approximately 54 subjects will be enrolled. The study population comprises healthy women, ages 18 to 45 years inclusive, who weigh at least 110 pounds, have a body mass index (BMI) between 16 and 29.9 kg per meter squared. Subjects will wear an EVRA® patch or take CILEST® during each of the three 7-day treatment periods; treatment periods will be separated by a 21-day washout period. When a subject is to wear EVRA®, a patch from 1 of the 6 selected commercial lots will be applied on the buttock and worn for 7 days. Patches will be applied by the investigator or designated study unit personnel. All patches will be worn on the upper outer quadrant of the same buttock, but not necessarily in the exact same position. The investigator or designated study unit personnel will remove the patches and will evaluate the adhesion of the patches before removal. When a subject is to receive CILEST®, tablets from 1 of the 3 selected commercial lots will be administered daily for 7 consecutive days. A minimum of 21 days after removal of the patch or the seventh dose of CILEST®, the subject will begin another treatment period, until she completes 3 open-label treatment periods. Subjects will be confined to the study unit for blood sample collections for determination of NGMN, NG, and EE plasma concentrations. Blood samples will be collected (via venipuncture) immediately before each dose and at specified time points after each dose is administered. Pharmacokinetic parameters of NGMN, NG, and EE, including Cmax, tmax, and AUC, after each treatment will be estimated by standard methods. Safety will be assessed throughout the study, and will be based on adverse events and changes in physical and gynecologic examinations (including breast examinations), vital signs, electrocardiograms (ECGs), and clinical laboratory test results.
Three 7-day treatment periods; treatments separated by 21-day washout. Based on the randomization schedule, some subjects will wear an EVRA® patch in all 3 periods (on the upper outer quadrant of the buttock for 7 days), some will wear a patch in 2 periods and take CILEST® oral tablets once daily in 1 period, and some will wear a patch in 1 period and take CILEST® oral tablets once daily in 2 periods.
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
Study ID Numbers: | CR002212 |
Study First Received: | November 22, 2005 |
Last Updated: | May 18, 2007 |
ClinicalTrials.gov Identifier: | NCT00258063 |
Health Authority: | United States: Institutional Review Board |
ethinyl estradiol contraceptive EVRA hormonal, steroid contraception |
Transdermal contraception progesterone CILEST ORTHO EVRA |
Norelgestromin Progesterone Benzoates Estradiol 3-benzoate Estradiol valerate |
Ethinyl Estradiol Ortho Evra Estradiol 17 beta-cypionate Polyestradiol phosphate Estradiol |
Contraceptives, Oral, Combined Estrogens Contraceptive Agents Therapeutic Uses Contraceptives, Oral Physiological Effects of Drugs |
Contraceptive Agents, Female Hormones, Hormone Substitutes, and Hormone Antagonists Reproductive Control Agents Hormones Pharmacologic Actions |