drugset / Trial / NCT00258063
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)
RandomizedCrossoverOpen-labelTreatment
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 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.
Timeline
- Start
- 2004-05
- Primary completion
- —
- Completion
- 2004-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CILEST | Unknown | — | Oral |
| Subject | ethinyl estradiol | Small molecule | 0.6 mg | Other |
| Subject | norelgestromin | Unknown | 6 mg | Other |
Indications
No indication recorded.