Phase 1
N=30
A Pharmacokinetic Study of Colchicine With an Oral Contraceptive
Pharmacokinetics
Bottom Line
View on ClinicalTrials.gov: NCT01040845 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Dec 2009
Primary outcome: Primary: Maximum Plasma Concentration of Norethindrone With Colchicine at Steady State (Cmax, ss) — 24.17 ng/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Norethindrone/Ethinyl Estradiol (Drug); Colchicine (Drug); Placebo (for Colchicine) (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Mutual Pharmaceutical Company, Inc.
- Primary completion
- Jan 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Plasma Concentration of Norethindrone With Colchicine at Steady State (Cmax, ss) |
24.17 | — |
| PRIMARY Maximum Plasma Concentration of Norethindrone With Placebo at Steady State (Cmax, ss) |
24.42 | — |
| PRIMARY Maximum Plasma Concentration of Ethinyl Estradiol With Colchicine at Steady State (Cmax, ss) |
0.14 | — |
| PRIMARY Maximum Plasma Concentration of Ethinyl Estradiol With Placebo at Steady State (Cmax, ss) |
0.15 | — |
| PRIMARY Maximum Plasma Concentration of Colchicine With Norethindrone/Ethinyl Estradiol at Steady State (Cmax, ss) |
3.11 | — |
| PRIMARY Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)] for Norethindrone With Colchicine |
175.57 | — |
| PRIMARY Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)] for Norethindrone With Placebo |
178.08 | — |
| PRIMARY Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)] Ethinyl Estradiol With Colchicine |
1.24 | — |
| PRIMARY Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)] for Ethinyl Estradiol With Placebo |
1.29 | — |
| PRIMARY Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)] for Colchicine With Norethindrone/Ethinyl Estradiol |
18.40 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Healthy, non-smoking female volunteers of childbearing potential aged 18 to 45 years weighing at least 55 kg and within 15% of ideal body weight who are taking oral contraceptives on the advice of their personal health care provider and willing to switch to Ortho-Novum 1/35
- Subjects should be either sexually inactive or using a double barrier method of contraception for 14 days before the first dose of study drug and throughout the study
Exclusion Criteria
- Pregnant or lactating
- Recent (2-year) history or evidence of alcoholism or drug abuse
- Test positive at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HbsAg), or hepatitis C antibody (HCV)
- History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease
- Hemoglobin < 12 g/dL
- Use of any drugs or substances known to inhibit or induce cytochrome (CYP) P450 enzymes and/or P-gp within 30 days prior to the first dose of Ortho-Novum® 1/35 or expected to require such use
Data sourced from ClinicalTrials.gov (NCT01040845). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.