GTx-024 as a Treatment for Stress Urinary Incontinence in Women
Condition: Stress Urinary Incontinence
MeSH terms: Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
Intervention: GTx-024
Intervention description: GTx-024 softgel capsules will be administered once-daily to a total dose of 3 mg
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 19.0
Sex: Female
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether GTx-024 is safe and effective in the
      treatment of stress urinary incontinence in postmenopausal women.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Give voluntary, written and signed, informed consent

          -  Female

          -  Age18 to 80 years old be clinically confirmed as postmenopausal. Subjects must have
             undergone the onset of spontaneous, medically induced or surgical menopause prior to
             the start of this study. Spontaneous menopause is defined as 12 months of spontaneous
             amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels > 40 mIU/ml or
             6 weeks postsurgical bilateral oophorectomy with or without hysterectomy

          -  SUI symptoms for at least 6 months duration

          -  Predominant SUI (MESA questionnaire)

          -  24 hour pad weight >3 gms at baseline

          -  A minimum of 1 SUI episode per day, in the 3 day diary

          -  3-15 SUI episodes per day, averaged over 3 days, in the 3 day diary

          -  Serum AST and ALT within normal limits

          -  Total bilirubin within normal limits

          -  Positive Bladder Stress Test during screening

          -  Subject agrees to not start any new treatment (medication or otherwise) that is known
             to affect lower urinary tract function throughout the treatment and follow up periods

          -  Subject agrees to maintain on a stable dose of any medication known to affect lower
             urinary tract function, including but not limited to anticholinergics, tricyclic
             antidepressants, or alpha-adrenergic blockers, throughout the treatment and follow-up
             period

        Exclusion Criteria:

          -  Pelvic floor physical therapy in a clinical setting within 30 days prior to screening

          -  History of pelvic radiation treatment

          -  History of urethral diverticula

          -  History of urethral sling, anterior prolapse repair, ureteral bulking agents and/or
             other SUI procedure or surgery

          -  Known vesicoureteral reflux, vaginal prolapse beyond the introitus, or other
             significant urological findings, including pelvic floor abnormalities which, in the
             judgement of the investigator, could impact treatment

          -  Urinary incontinence of neurogenic etilogy

          -  Patient is morbidly obese (defined as 100 pounds over their ideal body weight, or body
             mass index 40 or greater)

          -  Chronic hepatitis

          -  Hepatic cirrhosis

          -  HIV and/or hepatitis A, B, or C

          -  Subjects taking systemic hormone products

          -  Subjects with a history of breast or endometrial cancer

          -  Myocardial infarction or arterial thromboembolic events within 6 months prior to
             Baseline, severe or unstable angina, New York Heart Association (NYHA) Class III or IV
             disease, serious uncontrolled cardiac arrhythmia grade II or higher according to NYHA,
             uncontrolled hypertension (systolic > 150 and/or diastolic > 100 mm Hg)

          -  Subjects with an entry measurement of > 5 mm endometrial stripe thickness

          -  Clinically confirmed urinary tract infection

          -  Any other condition which per investigators' judgment may increase subject risk