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Oxybutinyn Vaginal Ring

Phase 3

Overactive Bladder | Small molecule | Nephrology |Teva Pharmaceutical Industries Limited|Trials Updated: Mar 16, 2023

Oxybutinyn Vaginal Ring development status

Highest phase Phase 3
Registered trials 1 across 1 sponsor since May 2001

Oxybutinyn Vaginal Ring target and mechanism

ModalitySmall molecule

Also known as DR-3001

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials2
Total Enrollment1,344

FDA Designations

No designations recorded

Oxybutinyn Vaginal Ring clinical trials

Oxybutinyn Vaginal Ring · 2 trials · 1 indication

Phase 3 2
NCT00685113A Clinical Trial to Evaluate the Efficacy and Safety of DR-3001 in Women With Overactive BladderOveractive Bladder
COMPLETED1,104 Analytics
NCT00782769A Safety Extension Study of DR-OXY-301Overactive Bladder
COMPLETED240 Analytics
PHASE3COMPLETED
A Clinical Trial to Evaluate the Efficacy and Safety of DR-3001 in Women With Overactive Bladder
Overactive BladderUnlock trial analytics
PHASE3COMPLETED
A Safety Extension Study of DR-OXY-301
Overactive BladderUnlock trial analytics

Study Endpoints

Primary Endpoints

Change in total weekly number of incontinence (urge and stress)episodes
Baseline to end-of-treamtent (Week 12/Early withdrawal)
Safety, by investigating post void residual volume, physical exams, vital signs, and clinical laboratory values. The outcome of any pregnancy will be followed and reported
Duration of Study

Secondary Endpoints

Change in average daily urinary frequency and average void volume
Baseline to end-of-treamtent (Week 12/Early withdrawal)
Proportion of subjects with no incontinence episodes recorded in the final 3-day diary
Final 3-day diary
3 subject-reported outcome measures: visual analogue scale of OAB symptoms, Urogenital Distress Inventory, Incontinence Impact Question
Baseline to end-of-treatment (Week 12/Early Withdrawal)
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL -
2EXPERIMENTAL -
3PLACEBO_COMPARATOR -
Oxybutinyn Vaginal Ring 4mgEXPERIMENTALinserted daily and replaced every 4 weeks
Oxybutinyn Vaginal Ring 6mgEXPERIMENTALinserted daily and replaced every 4 weeks

Interventions

NameTypeDescription
DR-3001DRUG4mg/day vaginal ring inserted vaginally and replaced every 4 weeks
PlaceboDRUGPlacebo vaginal ring inserted vaginally and replaced every 4 weeks
Oxybutinyn Vaginal Ring 4mgDRUG -
Oxybutinyn Vaginal Ring 6mgDRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexFEMALE
Healthy VolunteersYes
Study Sites84

Inclusion Criteria: * Women 18 years of age or older, ambulatory, with a history and presentation consistent with urge incontinence ≥ 6 months * Able to distinguish between stress and urge incontinence * During the Screening Period able to demonstrate the presence of overactive bladder with urge in...

Countries:United StatesCanada
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Frequently asked questions about Oxybutinyn Vaginal Ring

What is Oxybutinyn Vaginal Ring?

Oxybutinyn Vaginal Ring is an investigational small molecule therapy being developed for overactive bladder. It is a vaginal ring formulation designed to deliver oxybutynin, and it is also known as Oxybutinyn Vaginal Ring 4mg. It is currently in Phase 3 clinical development.

What is Oxybutinyn Vaginal Ring used for?

Oxybutinyn Vaginal Ring is being developed for the treatment of overactive bladder. The clinical program enrolled adult women aged 18 years and older with this condition. It is an investigational product and has not been established as a marketed treatment.

Who makes Oxybutinyn Vaginal Ring?

Oxybutinyn Vaginal Ring is being developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. Teva is the sponsor of the clinical program evaluating this vaginal ring formulation for overactive bladder.

What phase is Oxybutinyn Vaginal Ring in?

Oxybutinyn Vaginal Ring is in Phase 3 clinical development. One Phase 3 trial has been completed, and no trials are currently active. The drug remains investigational and is not approved for commercial use.

What clinical trials is Oxybutinyn Vaginal Ring in?

Oxybutinyn Vaginal Ring has been studied in one completed Phase 3 trial, NCT00782769, titled A Safety Extension Study of DR-OXY-301. The trial enrolled 240 participants in the United States, was randomized, double blind, and controlled, and included adult women aged 18 years and older with overactive bladder.