Stress Urinary IncontinencePhase 2NCT02658448

GTx-024 as a Treatment for Stress Urinary Incontinence in Women

A Phase 2 study testing GTx-024 in people with Stress Urinary Incontinence, run by GTx at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this study is to determine whether GTx-024 is safe and effective in the treatment of stress urinary incontinence in postmenopausal women. 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: 19 participants
Where: 3 sitesUnited States
Study dates: Jan 2016to Jun 2018
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Give voluntary, written and signed, informed consent
Female
Age18 to 80 years old be clinically confirmed as postmenopausal. Subjects must have undergone the onset of spontaneous, medically induced or surgical menopause prior to the start of this study. Spontaneous menopause is defined as 12 months of spontaneous amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels > 40 mIU/ml or 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy
SUI symptoms for at least 6 months duration
Predominant SUI (MESA questionnaire)
24 hour pad weight >3 gms at baseline

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A minimum of 1 SUI episode per day, in the 3 day diary
3-15 SUI episodes per day, averaged over 3 days, in the 3 day diary
Serum AST and ALT within normal limits
Total bilirubin within normal limits
Positive Bladder Stress Test during screening
Subject agrees to not start any new treatment (medication or otherwise) that is known to affect lower urinary tract function throughout the treatment and follow up periods
Subject agrees to maintain on a stable dose of any medication known to affect lower urinary tract function, including but not limited to anticholinergics, tricyclic antidepressants, or alpha-adrenergic blockers, throughout the treatment and follow-up period

Who cannot join

Pelvic floor physical therapy in a clinical setting within 30 days prior to screening
History of pelvic radiation treatment
History of urethral diverticula
History of urethral sling, anterior prolapse repair, ureteral bulking agents and/or other SUI procedure or surgery
Known vesicoureteral reflux, vaginal prolapse beyond the introitus, or other significant urological findings, including pelvic floor abnormalities which, in the judgement of the investigator, could impact treatment
Urinary incontinence of neurogenic etilogy

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Patient is morbidly obese (defined as 100 pounds over their ideal body weight, or body mass index 40 or greater)
Chronic hepatitis
Hepatic cirrhosis
HIV and/or hepatitis A, B, or C
Subjects taking systemic hormone products
Subjects with a history of breast or endometrial cancer
Myocardial infarction or arterial thromboembolic events within 6 months prior to Baseline, severe or unstable angina, New York Heart Association (NYHA) Class III or IV disease, serious uncontrolled cardiac arrhythmia grade II or higher according to NYHA, uncontrolled hypertension (systolic > 150 and/or diastolic > 100 mm Hg)
Subjects with an entry measurement of > 5 mm endometrial stripe thickness
Clinically confirmed urinary tract infection
Any other condition which per investigators' judgment may increase subject risk

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Urologic Consultants of Southeastern Pennsylvania
Bala-Cynwyd, Pennsylvania, 19004
Penn Center for Continence and Pelvic Health, University of Pennsylvania
Philadelphia, Pennsylvania, 19104
William Beaumont Hospital
Royal Oak, Michigan, 48073

Other trials in United States

About this study

Official title: GTx-024 as a Treatment for Stress Urinary Incontinence in Women: A Proof of Concept Study

The purpose of this study is to determine whether GTx-024 is safe and effective in the treatment of stress urinary incontinence in postmenopausal women.

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
GTx-024 softgel capsules will be administered once-daily to a total dose of 3 mg

Study groups in NCT02658448
Study group	Role	What they receive
GTx-024 3 mg	Experimental	GTx-024 softgel capsules will be administered once daily to a total dose of 3 mg for up to 12 weeks. Receives: Drug: GTx-024

What is being measured

The primary outcome is the main question the study is designed to answer.

The Mean Percent Change in Number of Stress Incontinence Episodes/Day as Assessed by Patient Completion of the 3 Day Voiding Diary
To describe the effect of 12 weeks of treatment of GTx-024 on the number of stress incontinence episodes/day as assessed by patient completion of the 3 day voiding diary
Measured: 12 weeks

Secondary outcomes (1)

Stress Urinary Incontinence as Assessed by 24 Hour Pad Weight Test. Mean Percent Change in Pad Weight
To describe the effect of 12 weeks of treatment of GTx-024 on SUI as assessed by 24 hour pad weight test. Mean percent reduction in pad weight
Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2016Jun 2018

First posted18 Jan 2016 (estimated)
Study startJan 2016
Primary completionJun 2018
Study completionJun 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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: 19 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02658448
Sponsor's protocol ID: G201001
Status last verified: Jan 2021
First submitted: 13 Jan 2016
Last updated: 1 Feb 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 3
A Study of Orforglipron in Female Participants With Stress Urinary Incontinence Who Have Obesity or Overweight
Urinary Incontinence,Stress
Active, not recruitingObservational study
Return to Physical Activity After Retropublic Transvaginal Sling and Laparoscopic Sacrocolpopexy
Stress Urinary Incontinence, Pelvic Organ Prolapse
RecruitingPhase 1
Allogeneic Use of Expanded Mesenchymal Stem Cells Derived From Adipose Tissue (HC106), Female Urinary Incontinence Women Over 50 Years Old
Urinary Incontinence Stress
Recruiting
The Application of Somatosensory Interactive Pelvic Floor Muscle Training for Stress Urinary Incontinence in Men Underwent Radical Prostatectomy
Prostate Cancer (Post Prostatectomy)
RecruitingObservational study
Standardized 4D Transperineal Ultrasound Assessment of Urethrovesical Junction Mobility After Vaginal Laser Treatment for Stress Urinary Incontinence.
Urinary Incontinence , Stress, Laser Therapy

All Stress Urinary Incontinence trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: GTx-024 as a Treatment for Stress Urinary Incontinence in Women: A Proof of Concept Study
ClinicalTrials.gov ID: NCT02658448
Acronym / sponsor ID: G201001
Conditions: Stress Urinary Incontinence
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 19 participants (actual)
Lead sponsor: GTxIndustry (pharma, biotech, devices)
Study start: Jan 2016 (actual)
Primary completion: Jun 2018 (actual)
Study completion: Jun 2018 (actual)
First posted: 18 Jan 2016 (estimated)
Results: Posted 1 Feb 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to determine whether GTx-024 is safe and effective in the treatment of stress urinary incontinence in postmenopausal women.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
GTx-024 3 mg	Experimental	Drug: GTx-024GTx-024 softgel capsules will be administered once daily to a total dose of 3 mg for up to 12 weeks.

Who may qualify

Ages: 18 to 80 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (13 listed)

Give voluntary, written and signed, informed consent
Female
Age18 to 80 years old be clinically confirmed as postmenopausal. Subjects must have undergone the onset of spontaneous, medically induced or surgical menopause prior to the start of this study. Spontaneous menopause is defined as 12 months of spontaneous amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels > 40 mIU/ml or 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy
SUI symptoms for at least 6 months duration
Predominant SUI (MESA questionnaire)

Key exclusion criteria (16 listed)

Pelvic floor physical therapy in a clinical setting within 30 days prior to screening
History of pelvic radiation treatment
History of urethral diverticula
History of urethral sling, anterior prolapse repair, ureteral bulking agents and/or other SUI procedure or surgery
Known vesicoureteral reflux, vaginal prolapse beyond the introitus, or other significant urological findings, including pelvic floor abnormalities which, in the judgement of the investigator, could impact treatment

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: enobosarmGTx-024 softgel capsules will be administered once-daily to a total dose of 3 mg	Drug	GTx-024 3 mg

Primary outcome

The Mean Percent Change in Number of Stress Incontinence Episodes/Day as Assessed by Patient Completion of the 3 Day Voiding Diary
Time frame: 12 weeks
To describe the effect of 12 weeks of treatment of GTx-024 on the number of stress incontinence episodes/day as assessed by patient completion of the 3 day voiding diary

1 secondary outcome

Stress Urinary Incontinence as Assessed by 24 Hour Pad Weight Test. Mean Percent Change in Pad Weight
Time frame: 12 weeks

Results and safety

Results posted to the registry on 1 Feb 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
GTx-024 3 mg	19	18

Primary outcome: The Mean Percent Change in Number of Stress Incontinence Episodes/Day as Assessed by Patient Completion of the 3 Day Voiding Diary

Time frame: 12 weeks. Mean (Full Range). Unit: percent reduction

Measure	GTx-024 3 mg n = 18
Value	81 (50 to 100)

Population analysed: all patients with at least one post enrollment assessment

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 12 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
GTx-024 3 mg	0 of 19 (0%)	9 of 19 (47.4%)	0 of 19

Limitations and caveats (from the sponsor): Open label, small number of subjects

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Stress Urinary Incontinence

RecruitingPhase 3
A Study of Orforglipron in Female Participants With Stress Urinary Incontinence Who Have Obesity or Overweight
Urinary Incontinence,Stress
Active, not recruitingObservational study
Return to Physical Activity After Retropublic Transvaginal Sling and Laparoscopic Sacrocolpopexy
Stress Urinary Incontinence, Pelvic Organ Prolapse
RecruitingPhase 1
Allogeneic Use of Expanded Mesenchymal Stem Cells Derived From Adipose Tissue (HC106), Female Urinary Incontinence Women Over 50 Years Old
Urinary Incontinence Stress
Recruiting
The Application of Somatosensory Interactive Pelvic Floor Muscle Training for Stress Urinary Incontinence in Men Underwent Radical Prostatectomy
Prostate Cancer (Post Prostatectomy)
RecruitingObservational study
Standardized 4D Transperineal Ultrasound Assessment of Urethrovesical Junction Mobility After Vaginal Laser Treatment for Stress Urinary Incontinence.
Urinary Incontinence , Stress, Laser Therapy

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 M. Peters, MD principal investigator

Corewell Health East

3 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 3 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 13 inclusion and 16 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: finished, as of the sponsor's last update on 1 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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?

Yes. Results are posted in the registry (first posted 1 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

The Mean Percent Change in Number of Stress Incontinence Episodes/Day as Assessed by Patient Completion of the 3 Day Voiding Diary (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02658448.

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 Feb 2021.