Stress Urinary IncontinencePhase 2NCT05674045
A Phase 2, Randomized, Placebo-controlled, Double-blind Study of EG017 in Female Patients With Stress Urinary Incontinence
A Phase 2 study testing EG017 3mg and EG017 6mg in people with Stress Urinary Incontinence, run by Changchun GeneScience Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
The purpose of this study is to determine whether EG017 is safe and effective in the treatment of stress urinary incontinence in postmenopausal women. Read more about this study
- Who is it for?
- Ages 40 to 65 years, women only
- Conditions the study is for
- Stress Urinary Incontinence
- What is being tested?
- EG017 3mg and EG017 6mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 1 siteChina
- Study dates
- 6 Jan 2022to 26 Sep 2022
- 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 40 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- SUI symptoms of at least 6 months duration Urinary incontinence in the 1-hour pad test weight≥5g and<30 g Moderate to severe urinary incontinence evaluated by ICIQ-SF
Who cannot join
- Patient has been diagnosed with mixed urinary incontinence (MUI) that is predominantly UUI Patient is considered to have SUI that would not be expected to improve unless treated with surgical therapy Patient had a history of surgical treatment for urinary incontinence (Trans-obturator tape surgery, Tension-free vaginal tape surgery, etc.) Patient has stage II or more of Pelvic Organ Prolapse (POP), or had a history of POP repair surgery before prior to study entry Patient has a serious illness or medical condition
Trial locations and contacts
1 site in 1 country.
China1 site
People's Hospital of Peking University
Beijing, Beijing Municipality, 100000
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-exploration Phase II Trial to Evaluate the Efficacy and Safety of EG017 Tablets in Postmenopausal Women With Stress Urinary Incontinence
The purpose of this study is to determine whether EG017 is safe and effective in the treatment of stress urinary incontinence in postmenopausal women.
Read the detailed description
The main purpose of this study is to assess the efficacy of EG017 in female patients with stress urinary incontinence (SUI) compared with placebo as measured by the percent change in the urinary incontinence volume measured in a 1-hour pad test from baseline at week 12.
- Conditions
- Stress Urinary Incontinence
- Being tested
- EG017 3mg, EG017 6mg
- Keywords
- stress urinary incontinence, Selective Androgen Receptor Modulator (SARM)
- 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.
EG017 3mgDrug
EG017 3mg/day Oral administration for 12 weeks, once daily
EG017 6mgDrug
EG017 6mg/day Oral administration for 12 weeks, once daily
| Study group | Role | What they receive |
|---|---|---|
| EG017 3mg | Experimental | Not described Receives: Drug: EG017 3mg |
| EG017 6mg | Experimental | Not described Receives: Drug: EG017 6mg |
| EG017 9mg | Experimental | Not described Receives: Drug: EG017 3mg; Drug: EG017 6mg |
| Placebo Comparator: matching placebo | Placebo comparator | Not described Receives: Drug: EG017 3mg; Drug: EG017 6mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
the percent change in the urinary incontinence volume measured in a 1-hour pad test
Measured: Baseline, week 12
Secondary outcomes (7)
The percent change in urinary incontinence volume measured in a 24-hour pad test
Measured: Baseline, week 12
The percent change in urinary incontinence volume measured in 1-hour and 24-hour pad test
Measured: Baseline, week 8 week20
The average urinary incontinence episode frequency per 24 hours
Measured: Baseline, week 8, week 12, week20
The change in the international Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF)
Measured: Baseline, week 8, week 12,week20
The change in UDI-6 scores
Measured: Baseline, week 8, week 12,week20
The change in PISQ-6 scores
Measured: Baseline, week 8, week 12,week20
Incidence of adverse events and side effects
Measured: Up 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 posted6 Jan 2023
- Study start6 Jan 2022
- Primary completion6 Jan 2022
- Study completion26 Sep 2022
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.
- More trials run by Changchun GeneScience Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Peking University People's Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05674045
- Sponsor's protocol ID
- GenSci1002021II
- Status last verified
- Oct 2022
- First submitted
- 30 Dec 2022
- Last updated
- 6 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-exploration Phase II Trial to Evaluate the Efficacy and Safety of EG017 Tablets in Postmenopausal Women With Stress Urinary Incontinence
- ClinicalTrials.gov ID
- NCT05674045
- Acronym / sponsor ID
- GenSci1002021II
- Conditions
- Stress Urinary Incontinence
- Keywords
- stress urinary incontinence, Selective Androgen Receptor Modulator (SARM)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Peking University People's Hospital
- Study start
- 6 Jan 2022 (actual)
- Primary completion
- 6 Jan 2022 (actual)
- Study completion
- 26 Sep 2022 (actual)
- First posted
- 6 Jan 2023 (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 purpose of this study is to determine whether EG017 is safe and effective in the treatment of stress urinary incontinence in postmenopausal women.
Detailed description
The main purpose of this study is to assess the efficacy of EG017 in female patients with stress urinary incontinence (SUI) compared with placebo as measured by the percent change in the urinary incontinence volume measured in a 1-hour pad test from baseline at week 12.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| EG017 3mg | Experimental | Drug: EG017 3mg |
| EG017 6mg | Experimental | Drug: EG017 6mg |
| EG017 9mg | Experimental | Drug: EG017 3mg, Drug: EG017 6mg |
| Placebo Comparator: matching placebo | Placebo comparator | Drug: EG017 3mg, Drug: EG017 6mg |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- SUI symptoms of at least 6 months duration Urinary incontinence in the 1-hour pad test weight≥5g and<30 g Moderate to severe urinary incontinence evaluated by ICIQ-SF
Key exclusion criteria (1 listed)
- Patient has been diagnosed with mixed urinary incontinence (MUI) that is predominantly UUI Patient is considered to have SUI that would not be expected to improve unless treated with surgical therapy Patient had a history of surgical treatment for urinary incontinence (Trans-obturator tape surgery, Tension-free vaginal tape surgery, etc.) Patient has stage II or more of Pelvic Organ Prolapse (POP), or had a history of POP repair surgery before prior to study entry Patient has a serious illness or medical condition
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 |
|---|---|---|
| EG017 3mgEG017 3mg/day Oral administration for 12 weeks, once daily | Drug | EG017 3mg, EG017 9mg, Placebo Comparator: matching placebo |
| EG017 6mgEG017 6mg/day Oral administration for 12 weeks, once daily | Drug | EG017 6mg, EG017 9mg, Placebo Comparator: matching placebo |
Primary outcome
the percent change in the urinary incontinence volume measured in a 1-hour pad test
Time frame: Baseline, week 12
7 secondary outcomes
The percent change in urinary incontinence volume measured in a 24-hour pad test
Time frame: Baseline, week 12
The percent change in urinary incontinence volume measured in 1-hour and 24-hour pad test
Time frame: Baseline, week 8 week20
The average urinary incontinence episode frequency per 24 hours
Time frame: Baseline, week 8, week 12, week20
The change in the international Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF)
Time frame: Baseline, week 8, week 12,week20
The change in UDI-6 scores
Time frame: Baseline, week 8, week 12,week20
The change in PISQ-6 scores
Time frame: Baseline, week 8, week 12,week20
Incidence of adverse events and side effects
Time frame: Up to 20 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing EG017 3mg and EG017 6mg in people with Stress Urinary Incontinence, run by Changchun GeneScience Pharmaceutical Co., Ltd. at 1 site in China.
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 1 inclusion and 1 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 6 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 percent change in the urinary incontinence volume measured in a 1-hour pad test (time frame: Baseline, week 12). 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 6 Jan 2023.