Stress Urinary IncontinencePhase 2NCT03508648
Durability Extension Study to Assess Clinical Activity and Safety 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
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… 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
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 46 sitesUnited States
- Study dates
- 28 May 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 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
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
- 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
Trial locations and contacts
46 sites in 1 country.
46 sites in 1 country
United States46 sites
Institute for Female Pelvic Medicine
Allentown, Pennsylvania, 18103
Alaska Clinical Research Center
Anchorage, Alaska, 99503
Elligo - Austin Area OBGYN
Austin, Texas, 78758
South 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
Delaware Valley Urology
Mount Laurel, New Jersey, 08054
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
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
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 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.
- Conditions
- Stress Urinary Incontinence
- Being tested
- GTx-024, Matching Placebo
- 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
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 PlaceboDrug
Subjects will not be provided with any study treatments and will be off-drug during this extension study. Intervention was administered during study G201002.
| Study group | Role | What they receive |
|---|---|---|
| Matching Placebo | Placebo comparator | Subjects previously enrolled in the placebo arm of study G201002. Receives: Drug: Matching Placebo |
| 1 mg GTx-024 | Active comparator | Subjects previously enrolled in the 1 mg GTx-024 arm of study G201002. Receives: Drug: GTx-024 |
| 3 mg GTx-024 | Active comparator | Subjects previously enrolled in the 3 mg GTx-024 arm of study G201002. Receives: Drug: GTx-024 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Durability of Response, stress incontinence
Change from G201002 baseline in the mean number of stress incontinence episodes per day
Measured: 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)
Measured: 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)
Measured: baseline to 20 weeks
Secondary outcomes (2)
Durability of Response, urge incontinence
Change from G201002 baseline in the mean number of urge incontinence episodes per day
Measured: 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
Measured: baseline to 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2018
- Study start28 May 2018
- Primary completion21 Sep 2018
- Study completion21 Sep 2018
Why it stopped: Lack of efficacy from primary study
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- 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
- NCT03508648
- Sponsor's protocol ID
- G201003
- Status last verified
- Sep 2023
- First submitted
- 16 Apr 2018
- Last updated
- 14 Sep 2023
- 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 14 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Durability Extension Study to Assess Clinical Activity and Safety of Enobosarm (GTx-024) in Postmenopausal Women With Stress Urinary Incontinence
- ClinicalTrials.gov ID
- NCT03508648
- Acronym / sponsor ID
- G201003
- Conditions
- Stress Urinary Incontinence
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of efficacy from primary study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- GTxIndustry (pharma, biotech, devices)
- Study start
- 28 May 2018 (actual)
- Primary completion
- 21 Sep 2018 (actual)
- Study completion
- 21 Sep 2018 (actual)
- First posted
- 26 Apr 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Matching Placebo | Placebo comparator | Drug: Matching PlaceboSubjects previously enrolled in the placebo arm of study G201002. |
| 1 mg GTx-024 | Active comparator | Drug: GTx-024Subjects previously enrolled in the 1 mg GTx-024 arm of study G201002. |
| 3 mg GTx-024 | Active comparator | Drug: GTx-024Subjects previously enrolled in the 3 mg GTx-024 arm of study G201002. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 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
- 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
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: enobosarmSubjects will not be provided with any study treatments and will be off-drug during this extension study. Intervention was administered during study G201002. | Drug | 1 mg GTx-024, 3 mg GTx-024 |
| Matching PlaceboSubjects will not be provided with any study treatments and will be off-drug during this extension study. Intervention was administered during study G201002. | Drug | Matching Placebo |
Primary outcome
Durability of Response, stress incontinence
Time frame: baseline to 20 weeks
Change from G201002 baseline in the mean number of stress incontinence episodes per day
Durability of Response, patient global impression of severity
Time frame: baseline to 20 weeks
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)
Durability of Response, patient global impression of improvement
Time frame: baseline to 20 weeks
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)
2 secondary outcomes
Durability of Response, urge incontinence
Time frame: baseline to 20 weeks
Durability of Response, total incontinence
Time frame: baseline to 20 weeks
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 14 Sep 2023.
- Individual participant dataSharing planned: No
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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 3 inclusion and 2 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 14 Sep 2023. 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. Some participants in this study may receive a placebo. 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?
Durability of Response, stress incontinence (time frame: baseline to 20 weeks). The study lists 3 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 14 Sep 2023.