drugset / Trial / NCT00254865
A Comparative Pharmacokinetic Study of ORTHO EVRA (a Transdermal Contraceptive Patch) and CILEST (an Oral Contraceptive) in Healthy Female Volunteers
RandomizedCrossoverOpen-labelTreatment
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.
Timeline
- Start
- 2002-08
- Primary completion
- —
- Completion
- 2003-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Norgestimate | Small molecule | 250 ug | Oral |
| Subject | ethinyl estradiol | Small molecule | 20 ug | Other |
| Subject | ethinyl estradiol | Small molecule | 35 ug | Other |
| Subject | norelgestromin | Unknown | 150 ug | Other |
Indications
No indication recorded.