Study to Assess Long-Term Safety/Tolerability of Enobosarm (GTx 024) in Stress Urinary Incontinence

Stress Urinary Incontinence Clinical Trial

Official title:

Phase 2, Open-Label Extension Study to Assess Long-Term Safety and Tolerability of Enobosarm (GTx 024) in Postmenopausal Women With Stress Urinary Incontinence

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03566290
• Other study ID #: G201004
• Status: Withdrawn
• Phase: Phase 2
• Start date: June 28, 2018
• Est. completion date: September 21, 2018

Study information

• Verified date: February 2024
• Source: GTx
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This open-label extension study, for subjects from the G201002 study, will provide additional long-term safety and tolerability data for GTx-024. All subjects in this study will receive GTx-024 3 mg orally, once daily.

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• Status: Withdrawn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 an eligible subject from G201002, where an eligible subject is defined as:

1. one of the first 225 subjects who were randomly assigned to the placebo group in G201002 and who have completed the required treatment and durability periods of that study, or;

2. any subject from 226 onwards, who was randomly assigned to any treatment group and who completed the required treatment and follow-up periods of that study

• Be able to read, understand, and provide written, dated, informed consent prior to enrollment in the current study and be likely to comply with the study protocol and communicate with study personnel about AEs and other clinically important information
• Provide written consent to participate in the study within the following timeframes:

1. for G201002 Subjects 1-225, within 30 days after unblinding of G201002 (subjects who consent to participate in G201003 will be allowed to discontinue from that study and consent to this study upon unblinding of G201002)

2. for G201002 Subjects 226-493, within 30 days of completing both the treatment and follow-up periods of G201002

• 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
• Subject is currently taking systemic sex-hormone products (excludes intravaginal application of estradiol topical/tablet agents and hormones delivered via vaginal rings)
• Has a current cancer diagnosis (with the exception of nonmelanoma skin cancer) or any history of breast or endometrial cancer
• Has a known history or current episode of:

1. New York Heart Association Stage = 2 hypertension (systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg) at screening and/or baseline. Subjects with hypertension that has been treated and controlled with medication for = 2 weeks prior to screening are eligible for participation

2. Recent myocardial infarction or arterial or venous thromboembolic event (within 1 year) or a history of more than 1 myocardial infarction or arterial or venous thromboembolic event

3. Cardiac-related syncopal event within the past year

4. Cardio or cerebral vascular disease requiring surgical intervention (e.g., bypass surgery, angioplasty). For subjects with previous stent placement, please contact the medical monitor

5. Congestive heart failure of Stage > 2 according to New York Heart Association criteria

6. Angina pectoris

• Has a current or past history of any physical condition that, in the investigator's opinion, might put the subject at risk, impact the absorption of the study drug, or interfere with interpretation of study

Related Conditions & MeSH terms

• Enuresis
• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

Drug:
• GTx-024
Study drug is an opaque, white to off-white, size 5, oval Softgel capsule containing the active ingredient GTx-024. Subjects will be required to take one 3 mg Softgel capsule per day.

Locations

Country	Name	City	State
United States	Alaska Clinical Research Center	Anchorage	Alaska
United States	Elligo - Austin Area OBGYN	Austin	Texas
United States	So. 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	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	Premier Medical Group	Poughkeepsie	New York
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	Urology of Virginia	Virginia Beach	Virginia
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	Safety of GTx-024, adverse events	Change from baseline in incidence of adverse events	baseline through study completion, an average of 1 year
Primary	Safety of GTx-024, liver function test	Change from baseline in liver function test	baseline through study completion, an average of 1 year
Primary	Safety of GTx-024, lipid panel	Change from baseline in lipid panel	baseline through study completion, an average of 1 year
Primary	Safety of GTx-024, sex-hormone binding globulin levels	Change from baseline in sex-hormone binding globulin levels	baseline through study completion, an average of 1 year
Primary	Safety of GTx-024, testosterone levels	Change from baseline in testosterone levels	baseline through study completion, an average of 1 year
Primary	Safety of GTx-024, endometrial stripe thickness	Change from baseline in endometrial stripe thickness as measured by transvaginal ultrasound	baseline through study completion, an average of 1 year
Primary	Safety of GTx-024, weight	Change from baseline weight	baseline through study completion, an average of 1 year
Secondary	Efficacy of GTx-024, stress incontinence	Change from baseline in the mean number of stress incontinence episodes per day	baseline through study completion, an average of 1 year
Secondary	Efficacy of GTx-024, patient global impression of severity	Change in patient global impression of severity (PGI-S; scale: 1-normal, 2-mild, 3-moderate, 4-severe; representing severity of urinary tract dysfunction)	baseline through study completion, an average of 1 year
Secondary	Efficacy of GTx-024, patient global impression of improvement	Change in patient global impression of improvement (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 through study completion, an average of 1 year
Secondary	Efficacy of GTx-024, urge incontinence	Change from baseline in the mean number of urge incontinence episodes per day	baseline through study completion, an average of 1 year
Secondary	Efficacy of GTx-024, total incontinence	Change from baseline in the mean number of total (stress + urge) incontinence episodes per day	baseline through study completion, an average of 1 year