Durability Extension Study to Assess Clinical Activity and Safety of Enobosarm (GTx-024) in Stress Urinary Incontinence

Phase 2 Durability Extension Study to Assess Clinical Activity and Safety of Enobosarm (GTx-024) in Postmenopausal Women With Stress Urinary Incontinence

The study will enroll only from the first 225 subjects who were randomly assigned to treatment in G201002 (irrespective of the treatment allocation, i.e., GTx-024 or placebo) and who have completed the 12-week treatment period and 16-week durability period to assess the long-term durability of response to GTx-024 on SUI symptoms. The extension study will follow subjects for an additional 20 weeks to help better assess the durability of response in these subjects and will provide additional efficacy and safety data for the subjects. Subjects will not be provided with any study treatments and will be off-drug during this extension study.

Study Overview

• Status: Withdrawn
• Conditions: Stress Urinary Incontinence
• Intervention / Treatment: Drug: Matching Placebo; Drug: GTx-024

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Homewood, Alabama, United States, 35209
      • Urology Center of Alabama
    • Mobile, Alabama, United States, 36608
      • Coastal Clinical Research Inc
  • Alaska
    • Anchorage, Alaska, United States, 99503
      • Alaska Clinical Research Center
  • Colorado
    • Denver, Colorado, United States, 80220
      • Genitourinary Surgical Consultants
    • Englewood, Colorado, United States, 80113
      • Urology Associates Research
  • Connecticut
    • Farmington, Connecticut, United States, 06032
      • Women's Health Specialty Care
    • New London, Connecticut, United States, 06320
      • Coastal Connecticut Research, LLC
  • Florida
    • Aventura, Florida, United States, 33180
      • South Florida Medical Research
    • Clearwater, Florida, United States, 33761
      • Tampa Bay Medical Research Inc
    • DeLand, Florida, United States, 32720
      • Midland Florida clinical Research Center LLC
    • Miami, Florida, United States, 33186
      • Medical Research of Florida
    • Pompano Beach, Florida, United States, 33060
      • Clinical Research Center Of Florida
  • Georgia
    • Sandy Springs, Georgia, United States, 30328
      • Mount Vernon Clinical Research LLC
  • Idaho
    • Idaho Falls, Idaho, United States, 83221
      • Clinical Research Prime
    • Meridian, Idaho, United States, 83642
      • Idaho Urologic Institue
  • Indiana
    • Jeffersonville, Indiana, United States, 47130
      • First Urology PSC
  • Iowa
    • West Des Moines, Iowa, United States, 50266
      • Iowa Clinic
  • Louisiana
    • New Orleans, Louisiana, United States, 70115
      • DelRicht Clinical Research, LLC
    • Shreveport, Louisiana, United States, 71106
      • Regional Urology
  • Maryland
    • Hanover, Maryland, United States, 21076
      • Chesapeake Urology Associates PA
  • Massachusetts
    • Boston, Massachusetts, United States, 02131
      • Boston Clinical Trials
    • Watertown, Massachusetts, United States, 02472
      • Bay State Clinical Trials
  • Michigan
    • Kalamazoo, Michigan, United States, 49009
      • Beyer Research
    • Royal Oak, Michigan, United States, 48073
      • William Beaumont Hospital Urology Research
  • Nebraska
    • Lincoln, Nebraska, United States, 68510
      • Women's Clinic of Lincoln
  • Nevada
    • Las Vegas, Nevada, United States, 89144
      • Sheldon J Freedman MD Ltd
  • New Jersey
    • Edison, New Jersey, United States, 08837
      • Premier Urology Group, LL
    • Lawrenceville, New Jersey, United States, 08648
      • Lawrence Obs Gyn clinical Research
    • Mount Laurel, New Jersey, United States, 08054
      • Delaware Valley Urology
  • New York
    • Garden City, New York, United States, 11530
      • AccuMed Research Associates
    • New York, New York, United States, 10016
      • Manhattan Medical Research Practice PLLC
    • West Seneca, New York, United States, 14224
      • Circuit Clinical
  • North Carolina
    • Charlotte, North Carolina, United States, 28207
      • American Health Research Inc
    • New Bern, North Carolina, United States, 28562
      • Eastern Carolina Women's
  • Ohio
    • Cincinnati, Ohio, United States, 45212
      • The Urology Group
    • Columbus, Ohio, United States, 43213
      • Aventiv Research
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18103
      • Institute for Female Pelvic Medicine
    • Bala-Cynwyd, Pennsylvania, United States, 19004
      • Urologic Consultants of Southeastern PA LLP
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania Health System
  • South Carolina
    • Mount Pleasant, South Carolina, United States, 29464
      • Coastal Carolina Research Center
  • Tennessee
    • Jackson, Tennessee, United States, 38305
      • The Jackson Clinic
  • Texas
    • Austin, Texas, United States, 78758
      • Elligo - Austin Area OBGYN
    • Dallas, Texas, United States, 75231
      • Urology Clinics of North Texas
    • San Antonio, Texas, United States, 78229
      • Urology San Antonio Research PA
  • Utah
    • Layton, Utah, United States, 84041
      • Synexus Clinical Research Advantage, Inc. - Wasatch Peak Family Practice
  • Washington
    • Seattle, Washington, United States, 98105
      • Seattle Womens: Health, Research, Gynocology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Be one of the first 225 subjects who were randomly assigned to treatment in G201002 (Phase 2 study) and have completed the 12-week treatment and 16-week durability periods
• Be able to read, understand, and provide written, dated informed consent prior to enrollment in the current study (within 2 weeks of completing G201002) and be likely to comply with the study protocol and communicate with study personnel about AEs and other clinically important information
• Agree to maintain a stable dose of any medication known to affect lower urinary tract function, including but not limited to anticholinergics, tricyclic antidepressants, beta-3 adrenergic agonists, or α-adrenergic blockers, throughout the duration of the study

Exclusion Criteria:

• Starts any new treatment (medication, pelvic floor physical therapy, or other treatment known to impact the pelvic floor) after completing G201002 that is known or suspected to affect lower urinary tract function, including vaginal rejuvenation
• Has a current or past history of any physical condition that, in the investigator's opinion, might put the subject at risk or interfere with interpretation of study results

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Matching Placebo; Subjects previously enrolled in the placebo arm of study G201002.	Drug: Matching Placebo; Subjects will not be provided with any study treatments and will be off-drug during this extension study. Intervention was administered during study G201002.
Active Comparator: 1 mg GTx-024; Subjects previously enrolled in the 1 mg GTx-024 arm of study G201002.	Drug: GTx-024; Subjects will not be provided with any study treatments and will be off-drug during this extension study. Intervention was administered during study G201002.; Other Names: enobosarm
Active Comparator: 3 mg GTx-024; Subjects previously enrolled in the 3 mg GTx-024 arm of study G201002.	Drug: GTx-024; Subjects will not be provided with any study treatments and will be off-drug during this extension study. Intervention was administered during study G201002.; Other Names: enobosarm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Durability of Response, stress incontinence	Change from G201002 baseline in the mean number of stress incontinence episodes per day	baseline to 20 weeks
Durability of Response, patient global impression of severity	Change from G201002 baseline in patient global impression of severity scale (PGI-S; scale: 1-normal, 2-mild, 3-moderate, 4-severe; representing severity of urinary tract dysfunction)	baseline to 20 weeks
Durability of Response, patient global impression of improvement	Change from G201002 baseline in patient global impression of improvement scale (PGI-I; scale: 1-very much better, 2-much better, 3-a little better, 4-no change, 5-a little worse, 6-much worse, 7-very much worse; representing change in urinary tract dysfunction from initiation of therapy)	baseline to 20 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Durability of Response, urge incontinence	Change from G201002 baseline in the mean number of urge incontinence episodes per day	baseline to 20 weeks
Durability of Response, total incontinence	Change from G201002 baseline in the mean number of total (stress + urge) incontinence episodes per day	baseline to 20 weeks

Collaborators and Investigators

• Sponsor: GTx
• Investigators: Principal Investigator: Kenneth Peters, MD, Professor & Chair, Department of Urology, Oakland University Wm. Beaumont School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): May 28, 2018
• Primary Completion (Actual): September 21, 2018
• Study Completion (Actual): September 21, 2018

Study Registration Dates

• First Submitted: April 16, 2018
• First Submitted That Met QC Criteria: April 24, 2018
• First Posted (Actual): April 26, 2018

Study Record Updates

• Last Update Posted (Actual): September 14, 2023
• Last Update Submitted That Met QC Criteria: September 12, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
• Other Study ID Numbers: G201003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No