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NCT00782769 · ClinicalTrials.gov registry record · Phase 3
A Safety Extension Study of DR-OXY-301
A Phase 3 study, sponsored by Duramed Research.
- Completed
- Registry status
- Phase 3
- Development phase
- 240
- Enrollment target
NCT00782769 is a Phase 3 study that has completed, run by Duramed Research. The registered enrollment target is 240 participants.
The verdict
NCT00782769, a Phase 3 study, has completed, sponsored by Duramed Research.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 240 participants
- Enrollment target
Study Summary
This is a safety extension study of DR-OXY-301 at pre-selected sites. Subjects who complete the DR-OXY-301 study are eligible to participate. The duration of this extension study will be up to approximately 42 weeks. Subjects will have physical and laboratory exams, including blood draws at each scheduled visit and colposcopic examination of the vagina and cervix. As in DR-OXY-301, subjects will be required to insert a vaginal ring; replacing it every 4 weeks. Subjects will also be required to keep a daily record of the number of times and the total amount of time the ring was outside the body each day and the reason for voluntary removal.
Interventions
- DRUG Oxybutinyn Vaginal Ring 4mg
- DRUG Oxybutinyn Vaginal Ring 6mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 240 participants |
| Start Date | 2008-09 |
| Est. Completion | 2010-07 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00782769
The ClinicalTrials.gov registry entry for NCT00782769 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 240 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duramed Research, which has 23 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Oxybutinyn Vaginal Ring 4mg is the first listed.
NCT00782769 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00782769 about?
NCT00782769 is a clinical study titled "A Safety Extension Study of DR-OXY-301". This is a safety extension study of DR-OXY-301 at pre-selected sites. Subjects who complete the DR-OXY-301 study are eligible to participate. The duration of this extension study will be up to approximately 42 weeks. Subjects will have physical and laboratory exams, including blood draws at each sch...
What is the current status of trial NCT00782769?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 240 participants. The study started on 2008-09. Estimated completion is 2010-07.
What interventions are being tested in trial NCT00782769?
The interventions under investigation include: Oxybutinyn Vaginal Ring 4mg (DRUG), Oxybutinyn Vaginal Ring 6mg (DRUG).
Who is sponsoring clinical trial NCT00782769?
This trial is sponsored by Duramed Research, which has 23 total clinical trials registered on ClinicalTrials.gov.
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