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NCT01040845 · ClinicalTrials.gov registry record · Phase 1
A Pharmacokinetic Study of Colchicine With an Oral Contraceptive
A Phase 1 study, sponsored by Mutual Pharmaceutical Company.
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
NCT01040845: Completed Phase 1 study, sponsored by Mutual Pharmaceutical Company.
NCT01040845 is a Phase 1 study that has completed, run by Mutual Pharmaceutical Company. The registered enrollment target is 30 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01040845, a Phase 1 study, has completed, sponsored by Mutual Pharmaceutical Company.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
Study 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.
Primary Outcome
The maximum or peak concentration that Norethindrone with Colchicine reaches in the plasma at steady state. Steady state refers to the point that constant concentration of drug is achieved subsequent to administration of constant doses of that drug given at constant intervals.
Interventions
- DRUG Colchicine
- DRUG Norethindrone/Ethinyl Estradiol
- DRUG Placebo (for Colchicine)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2007-08 |
| Est. Completion | 2008-02 |
| Phase | Phase 1 |
What the finished NCT01040845 record still lists
NCT01040845 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower).
The record links to 0 conditions, and to 3 interventions - of which Colchicine is the first listed.
NCT01040845 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01040845 about?
NCT01040845 is a clinical study titled "A Pharmacokinetic Study of Colchicine With an Oral Contraceptive". 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 norethindron...
What is the current status of trial NCT01040845?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2007-08. Estimated completion is 2008-02.
What interventions are being tested in trial NCT01040845?
The interventions under investigation include: Colchicine (DRUG), Norethindrone/Ethinyl Estradiol (DRUG), Placebo (for Colchicine) (DRUG).
Who is sponsoring clinical trial NCT01040845?
This trial is sponsored by Mutual Pharmaceutical Company, which has 27 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01040845's enrollment target sits among peer trials
30 1332nd of 2000 higher than 561 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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