Overactive Bladder
Conditions
Brief 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.
Interventions
DRUGDR-3001
4mg/day vaginal ring inserted vaginally and replaced every 4 weeks
DRUGPlacebo
Placebo vaginal ring inserted vaginally and replaced every 4 weeks
Sponsors
Duramed Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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 incontinence based on diary entries * Others as dictated by FDA-approved protocol
Exclusion criteria
* Stress incontinence, continuous incontinence or overflow urinary incontinence * Chronic illness, neurological dysfunction or injury that could cause incontinence * Pregnant, breastfeeding, or gave birth in the last 6 months * Others as dictated by FDA-approved protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in total weekly number of incontinence (urge and stress)episodes | Baseline to end-of-treamtent (Week 12/Early withdrawal) |
Secondary
| Measure | Time frame |
|---|---|
| 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) |
| Adverse events (AEs) reported by subjects or identified by the investigator | Basline to end-of-treatment (Week 12/Early Withdrawal) |
Countries
Canada, United States
Outcome results
None listed