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A Clinical Trial to Evaluate the Efficacy and Safety of DR-3001 in Women With Overactive Bladder

NCT00685113 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1104

Last updated 2016-07-20

No results posted yet for this study

Summary

This is a multicenter study to evaluate the efficacy and safety of 2 different doses of DR-3001. For eligible subjects the duration of the study will be approximately 20 weeks; this will consist of a 4-week screening period, a 12-week treatment period and a 4-week follow-up period. Subjects will have physical and laboratory exams, including blood draws at each scheduled visit. Subjects will be required to insert a vaginal ring (replacing it every 4 weeks) and to keep a daily record of their toilet voids (including time,type and volume) for 3 days at several specified time points.

Conditions

Interventions

DRUG

DR-3001

4mg/day vaginal ring inserted vaginally and replaced every 4 weeks

DRUG

DR-3001

6mg/day vaginal ring inserted vaginally and replaced every 4 weeks

DRUG

Placebo

Placebo vaginal ring inserted vaginally and replaced every 4 weeks

Sponsors & Collaborators

  • Duramed Research

    lead INDUSTRY

Principal Investigators

  • Duramed Research Protocol Chair · Duramed Research, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-05-31
Primary Completion
2010-03-31
Completion
2010-03-31

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00685113 on ClinicalTrials.gov