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

NCT03566290 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: G201004
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 46

Brief 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.

Conditions

Stress Urinary Incontinence

Outcome Measures

Primary Outcomes (7)

• Safety of GTx-024, adverse events

  Change from baseline in incidence of adverse events

  baseline through study completion, an average of 1 year

• Safety of GTx-024, liver function test

  Change from baseline in liver function test

  baseline through study completion, an average of 1 year

• Safety of GTx-024, lipid panel

  Change from baseline in lipid panel

  baseline through study completion, an average of 1 year

• 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

• Safety of GTx-024, testosterone levels

  Change from baseline in testosterone levels

  baseline through study completion, an average of 1 year

• 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

• Safety of GTx-024, weight

  Change from baseline weight

  baseline through study completion, an average of 1 year

Secondary Outcomes (5)

• Efficacy of GTx-024, stress incontinence

  baseline through study completion, an average of 1 year

• Efficacy of GTx-024, patient global impression of severity

  baseline through study completion, an average of 1 year

• Efficacy of GTx-024, patient global impression of improvement

  baseline through study completion, an average of 1 year

• Efficacy of GTx-024, urge incontinence

  baseline through study completion, an average of 1 year

• Efficacy of GTx-024, total incontinence

  baseline through study completion, an average of 1 year

Study Arms (1)

Open-Label Extension, 3 mg GTx-024

EXPERIMENTAL

Eligible subjects from G201002

Drug: GTx-024

Interventions

GTx-024 DRUG

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.

Also known as: enobosarm

Open-Label Extension, 3 mg GTx-024

Eligibility Criteria

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

You may qualify if:

• Be an eligible subject from G201002, where an eligible subject is defined as:
• 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;
• 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:
• 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)
• 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 α-adrenergic blockers, throughout the duration of the study

You may not qualify if:

• 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:
• 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
• 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
• Cardiac-related syncopal event within the past year
• Cardio or cerebral vascular disease requiring surgical intervention (e.g., bypass surgery, angioplasty). For subjects with previous stent placement, please contact the medical monitor
• Congestive heart failure of Stage \> 2 according to New York Heart Association criteria
• 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

Sponsors & Collaborators

• GTx: lead

Study Sites (46)

Urology Center of Alabama

Homewood, Alabama, 35209, United States

Location

Coastal Clinical Research Inc

Mobile, Alabama, 36608, United States

Location

Alaska Clinical Research Center

Anchorage, Alaska, 99503, United States

Location

Genitourinary Surgical Consultants

Denver, Colorado, 80220, United States

Location

Urology Associates Research

Englewood, Colorado, 80113, United States

Location

Women's Health Specialty Care

Farmington, Connecticut, 06032, United States

Location

Coastal Connecticut Research, LLC

New London, Connecticut, 06320, United States

Location

So. Florida Medical Research

Aventura, Florida, 33180, United States

Location

Tampa Bay Medical Research Inc

Clearwater, Florida, 33761, United States

Location

Midland Florida Clinical Research Center LLC

DeLand, Florida, 32720, United States

Location

Medical Research of Florida

Miami, Florida, 33186, United States

Location

Clinical Research Center of Florida

Pompano Beach, Florida, 33060, United States

Location

Mount Vernon Clinical Research LLC

Sandy Springs, Georgia, 30328, United States

Location

Clinical Research Prime

Idaho Falls, Idaho, 83221, United States

Location

Idaho Urologic Institue

Meridian, Idaho, 83642, United States

Location

First Urology PSC

Jeffersonville, Indiana, 47130, United States

Location

Iowa Clinic

West Des Moines, Iowa, 50266, United States

Location

DelRicht Clinical Research, LLC

New Orleans, Louisiana, 70115, United States

Location

Regional Urology

Shreveport, Louisiana, 71106, United States

Location

Chesapeake Urology Associates PA

Hanover, Maryland, 21076, United States

Location

Boston Clinical Trials

Boston, Massachusetts, 02131, United States

Location

Bay State clinical Trials

Watertown, Massachusetts, 02472, United States

Location

Beyer Research

Kalamazoo, Michigan, 49009, United States

Location

William Beaumont Hospital Urology Research

Royal Oak, Michigan, 48073, United States

Location

Women's Clinic of Lincoln

Lincoln, Nebraska, 68510, United States

Location

Sheldon J Freedman MD Ltd

Las Vegas, Nevada, 89144, United States

Location

Premier Urology Group, LL

Edison, New Jersey, 08837, United States

Location

Lawrence Obs Gyn clinical Research

Lawrenceville, New Jersey, 08648, United States

Location

Accumed Research Associates

Garden City, New York, 11530, United States

Location

Manhattan Medical Research Practice PLLC

New York, New York, 10016, United States

Location

Premier Medical Group

Poughkeepsie, New York, 12601, United States

Location

Circuit Clinical

West Seneca, New York, 14224, United States

Location

American Health Research Inc

Charlotte, North Carolina, 28207, United States

Location

Eastern Carolina Women's

New Bern, North Carolina, 28562, United States

Location

The Urology Group

Cincinnati, Ohio, 45212, United States

Location

Aventiv Research

Columbus, Ohio, 43213, United States

Location

Urologic Consultants of Southeastern PA LLP

Bala-Cynwyd, Pennsylvania, 19004, United States

Location

University of Pennsylvania Health System

Philadelphia, Pennsylvania, 19104, United States

Location

Coastal Carolina Research Center

Mt. Pleasant, South Carolina, 29464, United States

Location

The Jackson Clinic

Jackson, Tennessee, 38305, United States

Location

Elligo - Austin Area OBGYN

Austin, Texas, 78758, United States

Location

Urology Clinics of North Texas

Dallas, Texas, 75231, United States

Location

Urology San Antonio Research PA

San Antonio, Texas, 78229, United States

Location

Synexus Clinical Research Advantage, Inc. - Wasatch Peak Family Practice

Layton, Utah, 84041, United States

Location

Urology of Virginia

Virginia Beach, Virginia, 23462, United States

Location

Seattle Womens: Health, Research, Gynocology

Seattle, Washington, 98105, 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

Study Officials

• Kenneth Peters, MD

  Professor & Chair, Department of Urology, Oakland University Wm. Beaumont School of Medicine

  PRINCIPAL INVESTIGATOR

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: May 30, 2018
• First Posted: June 25, 2018
• Study Start: June 28, 2018
• Primary Completion: September 21, 2018
• Study Completion: September 21, 2018
• Last Updated: March 1, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (46)