Overview

A Pharmacokinetic Study of Colchicine With an Oral Contraceptive

Status:
Completed
Trial end date:
2008-02-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 1
Details
Lead Sponsor:
Mutual Pharmaceutical Company, Inc.
Treatments:
Colchicine
Contraceptive Agents
Contraceptives, Oral
Estradiol
Estradiol 17 beta-cypionate
Estradiol 3-benzoate
Estradiol valerate
Ethinyl Estradiol
Norethindrone
Norethindrone Acetate
Norethindrone acetate, ethinyl estradiol, ferrous fumarate drug combination
Norinyl
Polyestradiol phosphate