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Sponsored by: |
Organon |
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Information provided by: | Organon |
ClinicalTrials.gov Identifier: | NCT00779532 |
The trial is a single-center randomized, double-blind, double-dummy, placebo and positive controlled, parallel group clinical trial.
This trial investigated whether NOMAC-E2 (Org 10486 -0 + Org 2317), a new combined hormonal contraceptive, has potential to delay cardiac repolarization.
The primary measure of cardiac repolarization in this trial is the Fridericia corrected QT interval (QTcF). QTcF represents the duration of ventricular depolarization and subsequent repolarization. A delay in cardiac repolarization creates an electrophysiological environment that favors the development of cardiac arrhythmias, most clearly torsade de pointes (TdP), but possibly other ventricular tachyarrhythmias.
The primary aim of this study is to investigate, if the administration of a therapeutic (2.5/1.5 mg) or supra-therapeutic (higher than required for treatment: 12.5/7.5 mg) dose of NOMAC-E2 administered over a period of 14 days will prolong the mean QTcF interval to values above the accepted threshold of regulatory concern. In addition, a single dose of moxifloxacin will be administered in order to prove that sensitivity of the applied assay is sufficient to detect the prolongation of the QTcF-interval. Secondary aims of this study are to evaluate the relation between concentrations of NOMAC (therapeutic and supra-therapeutic) after steady state has been reached in the subject's body, the time matched change in Estradiol E1 and E2 in relation to baseline and the QTcF intervals after multiple dose administration of NOMAC-E2. Finally, the safety and tolerability of different treatments are investigated.
A total of 189 subjects will participate in this trial. The entire study duration is about 9 weeks with a 4-week screening period, 14-day treatment period and a follow-up period of about 3 weeks.
Condition | Intervention | Phase |
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Contraception |
Drug: Moxifloxacin Drug: NOMAC-E2 (Org 10486-0 + Org 2317) Drug: Moxifloxacin placebo Drug: NOMAC-E2 placebo |
Phase I |
Study Type: | Interventional |
Study Design: | Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety Study |
Official Title: | A Randomized, Double-Blind, Placebo and Positive Controlled, Parallel Group Trial to Investigate the Effect of Multiple Doses of NOMAC-E2 on QT/QTc Interval in Healthy Women |
Estimated Enrollment: | 189 |
Study Start Date: | May 2008 |
Study Completion Date: | October 2008 |
Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Group A: Active Comparator
Once daily intake (orally) of 5 NOMAC-E2 placebo tablets from Day -1 to Day 14. Once daily intake (orally) of one moxifloxacin placebo capsule at Day -1. Once daily intake (orally) of one moxifloxacin capsule of 400 mg at Day 14.
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Drug: Moxifloxacin
Capsules containing 400 mg moxifloxacin, on Day 14 only
Drug: Moxifloxacin placebo
Moxifloxacin-placebo capsule taken orally, Day -1 and Day 14 only
Drug: NOMAC-E2 placebo
Tablets containing NOMAC-E2 placebo, once daily dosing, orally taken.
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Group B: Experimental
Once daily intake (orally) of 4 NOMAC-E2 placebo tablets and 1 NOMAC-E2 (2.5/1.5 mg) tablet from Day 1 to Day 14. Once daily intake (orally) of 5 NOMAC-E2 placebo tablets and 1 moxifloxacin placebo capsule at Day -1. Once daily intake (orally) of 1 moxifloxacin placebo capsule at Day 14. |
Drug: NOMAC-E2 (Org 10486-0 + Org 2317)
Tablets containing 2.5 mg NOMAC and 1.5 mg E2, once daily dosing, orally taken. Daily dose either NOMAC-E2 2.5/1.5 mg or 12.5/7.5 mg.
Drug: Moxifloxacin placebo
Moxifloxacin-placebo capsule taken orally, Day -1 and Day 14 only
Drug: NOMAC-E2 placebo
Tablets containing NOMAC-E2 placebo, once daily dosing, orally taken.
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Group C: Experimental
Once daily intake (orally) of 5 NOMAC-E2 (2.5/1.5 mg) tablets from Day 1 to Day 14. Once daily intake (orally) of 5 NOMAC-E2 placebo tablets and 1 moxifloxacin placebo capsule at Day -1. Once daily intake (orally) of 1 moxifloxacin placebo capsule at Day 14 |
Drug: NOMAC-E2 (Org 10486-0 + Org 2317)
Tablets containing 2.5 mg NOMAC and 1.5 mg E2, once daily dosing, orally taken. Daily dose either NOMAC-E2 2.5/1.5 mg or 12.5/7.5 mg.
Drug: Moxifloxacin placebo
Moxifloxacin-placebo capsule taken orally, Day -1 and Day 14 only
Drug: NOMAC-E2 placebo
Tablets containing NOMAC-E2 placebo, once daily dosing, orally taken.
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Group D: Placebo Comparator
Once daily intake (orally) of 5 NOMAC-E2 placebo tablets from Day -1 to Day 14. Once daily intake (orally) of 1 moxifloxacin placebo capsule at Days -1 and 14.
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Drug: Moxifloxacin placebo
Moxifloxacin-placebo capsule taken orally, Day -1 and Day 14 only
Drug: NOMAC-E2 placebo
Tablets containing NOMAC-E2 placebo, once daily dosing, orally taken.
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Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Organon, part of Schering-Plough Corporation ( Study Director ) |
Study ID Numbers: | 292011, EudraCT # 2008-001649-25;, P05802 |
Study First Received: | October 23, 2008 |
Last Updated: | November 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00779532 History of Changes |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Electrocardiography Pharmacokinetics |
Moxifloxacin Healthy |
Anti-Infective Agents Moxifloxacin Therapeutic Uses Pharmacologic Actions |