CompletedPhase 2

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

United States118 participantsStarted 2005-05

Plain-language summary

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

Who can participate

Age range18 Years – 75 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Females between 18 and 75 years, inclusive Clinical diagnosis of OAB/UUI (symptoms of frequent micturition, urinary urgency) * Bladder capacity \</= 300 mL by cystometry 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

What they're measuring

Change in bladder capacity as determined by cystometric parameters from baseline to end of treatment.

Trial details

NCT IDNCT00174798

SponsorSanofi

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2006-05

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