drugset / Trial / NCT01040845
A Pharmacokinetic Study of Colchicine With an Oral Contraceptive
RandomizedCrossoverDouble-blindBasic science
Summary
This study will evaluate the effect, if any, of twice daily dosing of colchicine 0.6 mg at steady state on the steady state pharmacokinetic profile of ethinyl estradiol and norethindrone (Ortho-Novum 1/35). It will also evaluate the effects, if any, of steady state ethinyl estradiol and norethindrone on colchicine at steady state. Finally, this study will assess the safety and tolerability of concurrent use of colchicine and an estrogen/progesterone-containing oral contraceptive.
Timeline
- Start
- 2007-08
- Primary completion
- 2008-01
- Completion
- 2008-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Colchicine | Small molecule | 0.6 mg | Oral |
| Subject | Norethindrone | Unknown | 1 mg | Oral |
| Subject | ethinyl estradiol | Small molecule | 0.035 mg | Oral |
Indications
No indication recorded.