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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT03508648
Other study ID # G201003
Secondary ID
Status Withdrawn
Phase Phase 2
First received
Last updated
Start date May 28, 2018
Est. completion date September 21, 2018

Study information

Verified date September 2023
Source GTx
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date September 21, 2018
Est. primary completion date September 21, 2018
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 80 Years
Eligibility 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 a-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 Design


Intervention

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.
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.

Locations

Country Name City State
United States Institute for Female Pelvic Medicine Allentown Pennsylvania
United States Alaska Clinical Research Center Anchorage Alaska
United States Elligo - Austin Area OBGYN Austin Texas
United States South Florida Medical Research Aventura Florida
United States Urologic Consultants of Southeastern PA LLP Bala-Cynwyd Pennsylvania
United States Boston Clinical Trials Boston Massachusetts
United States American Health Research Inc Charlotte North Carolina
United States The Urology Group Cincinnati Ohio
United States Tampa Bay Medical Research Inc Clearwater Florida
United States Aventiv Research Columbus Ohio
United States Urology Clinics of North Texas Dallas Texas
United States Midland Florida Clinical Research Center LLC DeLand Florida
United States Genitourinary Surgical Consultants Denver Colorado
United States Premier Urology Group, LL Edison New Jersey
United States Urology Associates Research Englewood Colorado
United States Women's Health Specialty Care Farmington Connecticut
United States Accumed Research Associates Garden City New York
United States Chesapeake Urology Associates PA Hanover Maryland
United States Urology Center of Alabama Homewood Alabama
United States Clinical Research Prime Idaho Falls Idaho
United States The Jackson Clinic Jackson Tennessee
United States First Urology PSC Jeffersonville Indiana
United States Beyer Research Kalamazoo Michigan
United States Sheldon J Freedman MD Ltd Las Vegas Nevada
United States Lawrence Obs Gyn clinical Research Lawrenceville New Jersey
United States Synexus Clinical Research Advantage, Inc. - Wasatch Peak Family Practice Layton Utah
United States Women's Clinic of Lincoln Lincoln Nebraska
United States Idaho Urologic Institue Meridian Idaho
United States Medical Research of Florida Miami Florida
United States Coastal Clinical Research Inc Mobile Alabama
United States Delaware Valley Urology Mount Laurel New Jersey
United States Coastal Carolina Research Center Mount Pleasant South Carolina
United States Eastern Carolina Women's New Bern North Carolina
United States Coastal Connecticut Research, LLC New London Connecticut
United States DelRicht Clinical Research, LLC New Orleans Louisiana
United States Manhattan Medical Research Practice PLLC New York New York
United States University of Pennsylvania Health System Philadelphia Pennsylvania
United States Clinical Research Center of Florida Pompano Beach Florida
United States William Beaumont Hospital Urology Research Royal Oak Michigan
United States Urology San Antonio Research PA San Antonio Texas
United States Mount Vernon Clinical Research LLC Sandy Springs Georgia
United States Seattle Womens: Health, Research, Gynocology Seattle Washington
United States Regional Urology Shreveport Louisiana
United States Bay State Clinical Trials Watertown Massachusetts
United States Iowa Clinic West Des Moines Iowa
United States Circuit Clinical West Seneca New York

Sponsors (1)

Lead Sponsor Collaborator
GTx

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Durability of Response, stress incontinence Change from G201002 baseline in the mean number of stress incontinence episodes per day baseline to 20 weeks
Primary 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
Primary 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 Durability of Response, urge incontinence Change from G201002 baseline in the mean number of urge incontinence episodes per day baseline to 20 weeks
Secondary 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
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