Trial · NCT02658448
GTx-024 as a Treatment for Stress Urinary Incontinence in Women
NCT02658448, Phase 2, Completed, GTx; results first posted 2021-02-01
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. GTx-024 as a Treatment for Stress Urinary Incontinence in Women. Trials, record NCT02658448. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02658448
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- GTx-024 as a Treatment for Stress Urinary Incontinence in Women
- NCT number
- NCT02658448
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 19 participants, actual
- Lead sponsor
- GTx
- Conditions
- Stress Urinary Incontinence
- Interventions
- GTx-024
- First posted
- 2016-01-18
- Last updated
- 2021-02-01
- Results first posted
- 2021-02-01
- Limitations and caveats
- Open label, small number of subjects
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Mean Percent Change in Number of Stress Incontinence Episodes/Day as Assessed by Patient Completion of the 3 Day Voiding Diary | 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 |
| Secondary | Stress Urinary Incontinence as Assessed by 24 Hour Pad Weight Test. Mean Percent Change in Pad Weight | 12 weeks | 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 |
| Other | Number of Participants With Adverse Events | 12 weeks | To describe the safety profile of GTx-024 3 mg PO daily in subjects with stress urinary incontinence. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Mean Percent Change in Number of Stress Incontinence Episodes/Day as Assessed by Patient Completion of the 3 Day Voiding Diary | 12 weeks | all patients with at least one post enrollment assessment | percent reduction | MEAN |
| SECONDARY | Stress Urinary Incontinence as Assessed by 24 Hour Pad Weight Test. Mean Percent Change in Pad Weight | 12 weeks | all patients with at least one post enrollment assessment | percent | MEAN |
| OTHER_PRE_SPECIFIED | Number of Participants With Adverse Events | 12 weeks | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Mean Percent Change in Number of Stress Incontinence Episodes/Day as Assessed by Patient Completion of the 3 Day Voiding Diary | GTx-024 3 mg | 81 | Full Range 50 to 100 | percent reduction | |
| Stress Urinary Incontinence as Assessed by 24 Hour Pad Weight Test. Mean Percent Change in Pad Weight | GTx-024 3 mg | 71 | Full Range 27 to 126 | percent | |
| Number of Participants With Adverse Events | GTx-024 3 mg | 9 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | GTx-024 3 mg | 19 | |
| Overall Study | COMPLETED | GTx-024 3 mg | 18 | |
| Overall Study | NOT COMPLETED | GTx-024 3 mg | 1 |
Source ClinicalTrials.gov
Adverse events32
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | headache | General disorders | GTx-024 3 mg | 1 | 19 | 1 |
| other | nausea | Gastrointestinal disorders | GTx-024 3 mg | 1 | 19 | 1 |
| other | muscle soreness | Musculoskeletal and connective tissue disorders | GTx-024 3 mg | 1 | 19 | 1 |
| other | arthritis | Musculoskeletal and connective tissue disorders | GTx-024 3 mg | 1 | 19 | 1 |
| other | fatigue | General disorders | GTx-024 3 mg | 1 | 19 | 1 |
| other | hot flash | Endocrine disorders | GTx-024 3 mg | 1 | 19 | 1 |
| other | insomnia | General disorders | GTx-024 3 mg | 1 | 19 | 1 |
| other | urinary frequency | Renal and urinary disorders | GTx-024 3 mg | 1 | 19 | 1 |
| other | acne | Skin and subcutaneous tissue disorders | GTx-024 3 mg | 1 | 19 | 1 |
| other | tooth abscess | Infections and infestations | GTx-024 3 mg | 1 | 19 | 1 |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | GTx-024 3 mg | 0 | 19 |
| Total, other adverse events | GTx-024 3 mg | 9 | 19 |
| Total, serious adverse events | GTx-024 3 mg | 0 | 19 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02658448
GET https://conductscience.org/api/trials/v1/NCT02658448/events?page=2