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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 is a Phase 1 study that has completed, run by Mutual Pharmaceutical Company. The registered enrollment target is 30 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01040845
The ClinicalTrials.gov registry entry for NCT01040845 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mutual Pharmaceutical Company, which has 27 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Colchicine is the first listed.
NCT01040845 reports 0 study locations.
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.
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