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

NCT02658448 | Completed Phase 2 Results

• 1 other identifier: G201001
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 3

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.

Conditions

Stress Urinary Incontinence

Outcome Measures

Primary Outcomes (1)

• The Mean Percent Change in Number of Stress Incontinence Episodes/Day as Assessed by Patient Completion of the 3 Day Voiding Diary

  To describe the effect of 12 weeks of treatment of GTx-024 on the number of stress incontinence episodes/day as assessed by patient completion of the 3 day voiding diary

  12 weeks

Secondary Outcomes (1)

• Stress Urinary Incontinence as Assessed by 24 Hour Pad Weight Test. Mean Percent Change in Pad Weight

  12 weeks

Other Outcomes (1)

• Number of Participants With Adverse Events

  12 weeks

Study Arms (1)

GTx-024 3 mg

EXPERIMENTAL

GTx-024 softgel capsules will be administered once daily to a total dose of 3 mg for up to 12 weeks.

Drug: GTx-024

Interventions

GTx-024 DRUG

GTx-024 softgel capsules will be administered once-daily to a total dose of 3 mg

Also known as: enobosarm

GTx-024 3 mg

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• hour pad weight \>3 gms at baseline
• A minimum of 1 SUI episode per day, in the 3 day diary
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GTx: lead

Study Sites (3)

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

Urologic Consultants of Southeastern Pennsylvania

Bala-Cynwyd, Pennsylvania, 19004, United States

Location

Penn Center for Continence and Pelvic Health, University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress

Interventions

ostarine

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Open label, small number of subjects

Results Point of Contact

• Title: Mary Breitmeyer
• Organization: Oncternal

MBreitmeyer@oncternal.com

858-434-1113

Study Officials

• Kenneth M. Peters, MD

  Corewell Health East

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2016
• First Posted: January 18, 2016
• Study Start: January 1, 2016
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: February 1, 2021
• Results First Posted: February 1, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)