MILADY: A Randomized, Placebo-controlled Safety and Efficacy Trial of SSR240600C in Treatment of Overactive Bladder or Urge Urinary Incontinence.

• Status: Completed
• Trial end date: 2006-05-01
• Target enrollment: 0
• Participant gender: Female

Summary

To evaluate the safety and efficacy of SSR240600C versus placebo on clinical and cystometric parameters in patients with OAB and UUI.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Tolterodine Tartrate

Criteria

Inclusion Criteria:

• Females between 18 and 75 years, inclusive Clinical diagnosis of OAB/UUI (symptoms of frequent micturition, urinary urgency)

• Bladder capacity Exclusion Criteria:

• History of interstitial cystitis, bladder outlet obstruction or other significant genitourinary disorder

• Current urinary tract infection

• Neurological bladder dysfunction

• Treatment with drugs that may interfere with CYP3A4 metabolic function

• History of stress urinary incontinence