CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 30 enrolled
Drug / intervention
Norethindrone/Ethinyl Estradiol +2 moredrug
Likely dose
Norethindrone/Ethinyl Estradiol 1 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01040845
NCT01040845Phase 1Completed
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A Pharmacokinetic Study to Evaluate the Effect of Colchicine on the Pharmacokinetic Profile of an Oral Contraceptive Containing Ethinyl Estradiol and Norethindrone in Healthy Women

Mutual Pharmaceutical Company, Inc.·interventional·Posted Dec 30, 2009·Updated Jan 5, 2010

In Brief

A Phase 1 clinical trial evaluating Norethindrone/Ethinyl Estradiol, Colchicine, and 1 other intervention for Pharmacokinetics. Completed, enrolled 30 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPharmacokinetics
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 30, 2009
Enrollment StartAug 1, 2007
Primary CompletionJan 1, 2008
Study CompletionFeb 1, 2008
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 16.5 years ago

Interventions

Norethindrone/Ethinyl Estradioldrug

one tablet daily - 1 mg norethindrone/0.035 mg ethinyl estradiol on Days 1 to 21; inert ingredients on Days 22 to 28

Colchicinedrug

0.6mg tablet every 12 hours on Days 8 to 21

Placebo (for Colchicine)drug

placebo tablet every 12 hours on Days 8 to 21