Stress Urinary IncontinencePhase 2NCT03566290
Study to Assess Long-Term Safety/Tolerability of Enobosarm (GTx 024) in Stress Urinary Incontinence
A Phase 2 study testing GTx-024 in people with Stress Urinary Incontinence, run by GTx at 46 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Stress Urinary Incontinence
- What is being tested?
- GTx-024
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 46 sitesUnited States
- Study dates
- 28 Jun 2018to 21 Sep 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
46 sites in 1 country.
46 sites in 1 country
United States46 sites
Alaska Clinical Research Center
Anchorage, Alaska, 99503
Elligo - Austin Area OBGYN
Austin, Texas, 78758
So. Florida Medical Research
Aventura, Florida, 33180
Urologic Consultants of Southeastern PA LLP
Bala-Cynwyd, Pennsylvania, 19004
Boston Clinical Trials
Boston, Massachusetts, 02131
American Health Research Inc
Charlotte, North Carolina, 28207
The Urology Group
Cincinnati, Ohio, 45212
Tampa Bay Medical Research Inc
Clearwater, Florida, 33761
Aventiv Research
Columbus, Ohio, 43213
Urology Clinics of North Texas
Dallas, Texas, 75231
Midland Florida Clinical Research Center LLC
DeLand, Florida, 32720
Genitourinary Surgical Consultants
Denver, Colorado, 80220
Premier Urology Group, LL
Edison, New Jersey, 08837
Urology Associates Research
Englewood, Colorado, 80113
Women's Health Specialty Care
Farmington, Connecticut, 06032
Accumed Research Associates
Garden City, New York, 11530
Chesapeake Urology Associates PA
Hanover, Maryland, 21076
Urology Center of Alabama
Homewood, Alabama, 35209
Clinical Research Prime
Idaho Falls, Idaho, 83221
The Jackson Clinic
Jackson, Tennessee, 38305
First Urology PSC
Jeffersonville, Indiana, 47130
Beyer Research
Kalamazoo, Michigan, 49009
Sheldon J Freedman MD Ltd
Las Vegas, Nevada, 89144
Lawrence Obs Gyn clinical Research
Lawrenceville, New Jersey, 08648
Synexus Clinical Research Advantage, Inc. - Wasatch Peak Family Practice
Layton, Utah, 84041
Women's Clinic of Lincoln
Lincoln, Nebraska, 68510
Idaho Urologic Institue
Meridian, Idaho, 83642
Medical Research of Florida
Miami, Florida, 33186
Coastal Clinical Research Inc
Mobile, Alabama, 36608
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, 29464
Eastern Carolina Women's
New Bern, North Carolina, 28562
Coastal Connecticut Research, LLC
New London, Connecticut, 06320
DelRicht Clinical Research, LLC
New Orleans, Louisiana, 70115
Manhattan Medical Research Practice PLLC
New York, New York, 10016
University of Pennsylvania Health System
Philadelphia, Pennsylvania, 19104
Clinical Research Center of Florida
Pompano Beach, Florida, 33060
Premier Medical Group
Poughkeepsie, New York, 12601
William Beaumont Hospital Urology Research
Royal Oak, Michigan, 48073
Urology San Antonio Research PA
San Antonio, Texas, 78229
Mount Vernon Clinical Research LLC
Sandy Springs, Georgia, 30328
Seattle Womens: Health, Research, Gynocology
Seattle, Washington, 98105
Regional Urology
Shreveport, Louisiana, 71106
Urology of Virginia
Virginia Beach, Virginia, 23462
Bay State clinical Trials
Watertown, Massachusetts, 02472
Iowa Clinic
West Des Moines, Iowa, 50266
Circuit Clinical
West Seneca, New York, 14224
About this study
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
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
- Being tested
- GTx-024
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GTx-024Drug
Also called enobosarm
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.
| Study group | Role | What they receive |
|---|---|---|
| Open-Label Extension, 3 mg GTx-024 | Experimental | Eligible subjects from G201002 Receives: Drug: GTx-024 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of GTx-024, adverse events
Change from baseline in incidence of adverse events
Measured: baseline through study completion, an average of 1 year
Safety of GTx-024, liver function test
Change from baseline in liver function test
Measured: baseline through study completion, an average of 1 year
Safety of GTx-024, lipid panel
Change from baseline in lipid panel
Measured: 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
Measured: baseline through study completion, an average of 1 year
Safety of GTx-024, testosterone levels
Change from baseline in testosterone levels
Measured: 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
Measured: baseline through study completion, an average of 1 year
Safety of GTx-024, weight
Change from baseline weight
Measured: baseline through study completion, an average of 1 year
Secondary outcomes (5)
Efficacy of GTx-024, stress incontinence
Change from baseline in the mean number of stress incontinence episodes per day
Measured: baseline through study completion, an average of 1 year
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)
Measured: baseline through study completion, an average of 1 year
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)
Measured: baseline through study completion, an average of 1 year
Efficacy of GTx-024, urge incontinence
Change from baseline in the mean number of urge incontinence episodes per day
Measured: baseline through study completion, an average of 1 year
Efficacy of GTx-024, total incontinence
Change from baseline in the mean number of total (stress + urge) incontinence episodes per day
Measured: baseline through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2018
- Study start28 Jun 2018
- Primary completion21 Sep 2018
- Study completion21 Sep 2018
Why it stopped: Development of investigational product was halted.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- GTx
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kenneth Peters, MD, Principal investigator, Professor & Chair, Department of Urology, Oakland University Wm. Beaumont School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03566290
- Sponsor's protocol ID
- G201004
- Status last verified
- Feb 2024
- First submitted
- 30 May 2018
- Last updated
- 1 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03566290
- Acronym / sponsor ID
- G201004
- Conditions
- Stress Urinary Incontinence
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Development of investigational product was halted.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- GTxIndustry (pharma, biotech, devices)
- Study start
- 28 Jun 2018 (actual)
- Primary completion
- 21 Sep 2018 (actual)
- Study completion
- 21 Sep 2018 (actual)
- First posted
- 25 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open-Label Extension, 3 mg GTx-024 | Experimental | Drug: GTx-024Eligible subjects from G201002 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Be an eligible subject from G201002, where an eligible subject is defined as:
- 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:
- 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
Key exclusion criteria (11 listed)
- 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:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GTx-024Also: enobosarmStudy 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. | Drug | Open-Label Extension, 3 mg GTx-024 |
Primary outcome
Safety of GTx-024, adverse events
Time frame: baseline through study completion, an average of 1 year
Change from baseline in incidence of adverse events
Safety of GTx-024, liver function test
Time frame: baseline through study completion, an average of 1 year
Change from baseline in liver function test
Safety of GTx-024, lipid panel
Time frame: baseline through study completion, an average of 1 year
Change from baseline in lipid panel
Safety of GTx-024, sex-hormone binding globulin levels
Time frame: baseline through study completion, an average of 1 year
Change from baseline in sex-hormone binding globulin levels
Safety of GTx-024, testosterone levels
Time frame: baseline through study completion, an average of 1 year
Change from baseline in testosterone levels
Safety of GTx-024, endometrial stripe thickness
Time frame: baseline through study completion, an average of 1 year
Change from baseline in endometrial stripe thickness as measured by transvaginal ultrasound
Safety of GTx-024, weight
Time frame: baseline through study completion, an average of 1 year
Change from baseline weight
5 secondary outcomes
Efficacy of GTx-024, stress incontinence
Time frame: baseline through study completion, an average of 1 year
Efficacy of GTx-024, patient global impression of severity
Time frame: baseline through study completion, an average of 1 year
Efficacy of GTx-024, patient global impression of improvement
Time frame: baseline through study completion, an average of 1 year
Efficacy of GTx-024, urge incontinence
Time frame: baseline through study completion, an average of 1 year
Efficacy of GTx-024, total incontinence
Time frame: baseline through study completion, an average of 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2024.
- Individual participant dataSharing planned: No
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Allogeneic Use of Expanded Mesenchymal Stem Cells Derived From Adipose Tissue (HC106), Female Urinary Incontinence Women Over 50 Years Old
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RecruitingObservational study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenneth Peters, MD principal investigator
Professor & Chair, Department of Urology, Oakland University Wm. Beaumont School of Medicine
46 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GTx-024 in people with Stress Urinary Incontinence, run by GTx at 46 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 1 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 46 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of GTx-024, adverse events (time frame: baseline through study completion, an average of 1 year). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2024.