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

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ClinicalTrials.gov Identifier: NCT02658448
Recruitment Status : Completed
First Posted : January 18, 2016
Last Update Posted : September 25, 2018
Sponsor:
Information provided by (Responsible Party):
GTx

Brief 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.

Condition or disease Intervention/treatment Phase
Stress Urinary Incontinence Drug: GTx-024 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: GTx-024 as a Treatment for Stress Urinary Incontinence in Women: A Proof of Concept Study
Actual Study Start Date : January 2016
Actual Primary Completion Date : June 2018
Actual Study Completion Date : June 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: GTx-024 3 mg
GTx-024 softgel capsules will be administered once daily to a total dose of 3 mg for up to 12 weeks.
Drug: GTx-024
GTx-024 softgel capsules will be administered once-daily to a total dose of 3 mg
Other Name: enobosarm




Primary Outcome Measures :
  1. The number of stress incontinence episodes/day. [ Time Frame: 12 weeks ]
    To describe the effect of 12 weeks of treatment of GTx-024 on the number of stress incontinence episodes/day.


Secondary Outcome Measures :
  1. Stress urinary incontinence as assessed by 24 hour pad weight test [ Time Frame: 12 weeks ]
    To describe the effect of 12 weeks of treatment of GTx-024 on SUI as assessed by 24 hour pad weight test.

  2. Stress urinary incontinence as assessed by the Bladder Stress Test [ Time Frame: 12 weeks ]
    To describe the effect of 12 weeks of treatment of GTx-024 on SUI as assessed by the Bladder Stress Test.

  3. MESA Urinary Questionnaire [ Time Frame: 12 weeks ]
    To describe the effect of 12 weeks of treatment of GTx-024 on patient reported stress urinary incontinence symptoms as assessed by the MESA Urinary Questionnaire.

  4. Patient Global Impression of Severity Scale (PGI-S) [ Time Frame: 12 weeks ]
    To describe the effect of 12 weeks of treatment of GTx-024 on patient reported impression of stress urinary incontinence severity as assessed by the Patient Global Impression of Severity Scale (PGI-S)

  5. Patient Global Impression of Improvement Scale (PGI-I) [ Time Frame: 12 weeks ]
    To describe the effect of 12 weeks of treatment of GTx-024 on patient reported impression of improvement as assessed by the Patient Global Impression of Improvement Scale (PGI-I).

  6. Urinary Distress Inventory Questionnaire (UDI-6) [ Time Frame: 12 weeks ]
    To describe the effect of 12 weeks of treatment of GTx-024 on patient reported urogenital distress as assessed by the Urinary Distress Inventory Questionnaire (UDI-6).

  7. Incontinence Impact Questionnaire (IIQ-7) [ Time Frame: 12 weeks ]
    To describe the effect of 12 weeks of treatment of GTx-024 on patient reported impact of urinary incontinence on daily life as assessed by the Incontinence Impact Questionnaire (IIQ-7).

  8. Female Sexual Function Index Questionnaire (FSFI) [ Time Frame: 12 weeks ]
    To describe the effect of 12 weeks of treatment of GTx-024 on patient reported sexual function as indicated on the completion of the Female Sexual Function Index Questionnaire (FSFI).

  9. Changes in pelvic floor muscles as assessed by MRI, in patients where a MRI is not contraindicated [ Time Frame: 12 weeks ]
    Quantitative assessments may include the area of the levator ani , the anteroposterior and transverse diameters, and/or other relevant parameters.

  10. The number of voids/day [ Time Frame: 12 weeks ]
    To describe the effect of 12 weeks of treatment of GTx-024 on the number of voids/day


Other Outcome Measures:
  1. Adverse events [ Time Frame: 12 weeks ]
    To describe the safety profile of GTx-024 3 mg PO daily in subjects with stress urinary incontinence.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02658448


Locations
United States, Michigan
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
United States, Pennsylvania
Urologic Consultants of Southeastern Pennsylvania
Bala-Cynwyd, Pennsylvania, United States, 19004
Penn Center for Continence and Pelvic Health, University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
GTx
Investigators
Principal Investigator: Kenneth M. Peters, MD William Beaumont Hospitals

Responsible Party: GTx
ClinicalTrials.gov Identifier: NCT02658448     History of Changes
Other Study ID Numbers: G201001
First Posted: January 18, 2016    Key Record Dates
Last Update Posted: September 25, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Urinary Incontinence
Enuresis
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders