GTx-024 as a Treatment for Stress Urinary Incontinence in Women

GTx

Status and phase

Completed

Phase 2

Conditions

Stress Urinary Incontinence

Treatments

Drug: GTx-024

Study type

Interventional

Funder types

Industry

Identifiers

NCT02658448

G201001

Details and patient eligibility

About

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.

Enrollment

19 patients

Sex

Female

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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