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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: Completed Phase 3 study, sponsored by Duramed Research.

NCT00782769 is a Phase 3 study that has completed, run by Duramed Research. The registered enrollment target is 240 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (69% lower). According to ClinicalTrials.gov, the official US trial registry.

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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

FieldValue
Enrollment Target 240 participants
Start Date 2008-09
Est. Completion 2010-07
Phase Phase 3
Duramed Research

23 total trials

What the finished NCT00782769 record still lists

NCT00782769 is an interventional study that assigns participants to a tested intervention. The registered 240 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (69% lower).

The record links to 0 conditions, and to 2 interventions - of which Oxybutinyn Vaginal Ring 4mg is the first listed.

NCT00782769 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT00782769's enrollment target sits among peer trials

240 1273rd of 2000 higher than 710 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 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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Source: ClinicalTrials.gov NCT00782769, the US trial registry maintained by the National Library of Medicine. NCT00782769 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.