A Study of Oxybutynin for the Treatment of Urge Urinary Incontinence


The purpose of this study is to determine the safety of three doses of oxybutynin for the treatment of urge urinary incontinence.

Full Title of Study: “An Open-Label, Dose Escalating Study to Evaluate the Safety of Intravaginal Oxybutynin in Subjects With Urge Urinary Incontinence”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 2008


  • Drug: oxybutynin
    • low dose oxybutynin administered daily
  • Drug: oxybutynin
    • middle dose oxybutynin administered daily
  • Drug: oxybutynin
    • high dose oxybutynin administered daily

Arms, Groups and Cohorts

  • Active Comparator: 1
  • Active Comparator: 2
  • Active Comparator: 3

Clinical Trial Outcome Measures

Primary Measures

  • Number of micturations and incontinence episodes.
    • Time Frame: Two weeks pretreatment and three weeks on treatment

Participating in This Clinical Trial

Inclusion Criteria

  • Females 18 to 75 years of age – Has reported symptoms of urge urinary incontinence/overactive bladder Exclusion Criteria:

  • Is pregnant or lactating – Has had lower urinary tract surgery within 6 months prior to Screening – Has a history of urinary retention

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • FemmePharma Global Healthcare, Inc.
  • Provider of Information About this Clinical Study
    • Peter K. Mays, Ph.D. / V.P. Pharmaceutical Development, FemmePharma Global Healthcare, Inc.
  • Overall Official(s)
    • Peter K. Mays, Ph.D., Study Director, FemmePharma Global Healthcare, Inc.

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