A Safety Extension Study of DR-OXY-301

Duramed Research

Status and phase: Completed; Phase 3

Conditions: Overactive Bladder

Treatments: Drug: Oxybutinyn Vaginal Ring 6mg; Drug: Oxybutinyn Vaginal Ring 4mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00782769

DR-OXY-302

Details and patient eligibility

About

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.

Enrollment: 240 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Completed the 12 weeks of treatment in the DR-OXY-301 study
• Willing to limit medications for overactive bladder to investigational product only
• Able to understand and complete all study procedures including the required diary

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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240 participants in 2 patient groups

Oxybutinyn Vaginal Ring 4mg

Experimental group

Description:

inserted daily and replaced every 4 weeks

Treatment:

Drug: Oxybutinyn Vaginal Ring 4mg

Oxybutinyn Vaginal Ring 6mg

Experimental group

Description:

inserted daily and replaced every 4 weeks

Treatment:

Drug: Oxybutinyn Vaginal Ring 6mg