Persistent Genital Arousal DisorderNCT05919784
Examining the Effectiveness of a Group Cognitive-behavioural Treatment Program for Persistent Genital Arousal Disorder
A study testing Cognitive behavioural therapy in people with Persistent Genital Arousal Disorder, run by Dr. Caroline Pukall at 1 site in Canada.
Trial summary
This study seeks to provide information regarding the effectiveness of a virtual, synchronous cognitive behavioural therapy (CBT) group program for women with Persistent Genital Arousal Disorder/Genitopelvic Dysesthesia (PGAD/GPD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Persistent Genital Arousal Disorder
- What is being tested?
- Cognitive behavioural therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteCanada
- Study dates
- 24 Apr 2023to 31 May 2025
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- at least 18 years of age
- fluent in English
- have a physician-based diagnosis of PGAD/GPD
- reside in Ontario, Canada
- be comfortable answering questions about their health (mental and physical) and sexuality in online surveys
- be comfortable discussing their mental and physical health and PGAD/GPD symptoms in group online therapy sessions with video on
Who cannot join
- under the age of 18 years
- nonfluent in English
- lack of physician based diagnosis of PGAD/GPD
- not comfortable with answering questions about mental, physical, sexual health
- not comfortable with discussing mental and physical health and PGAD/GPD symptoms in group online therapy sessions with video on
- mental or physical health conditions that preclude involvement in group therapy
Trial locations and contacts
1 site in 1 country.
Canada1 site
Sexual Health Research Laboratory, Department of Psychology, Queen's University
Kingston, Ontario, K7L 3N6
About this study
Official title: Examining the Effectiveness of a Group Cognitive-behavioural Treatment Program for Persistent Genital Arousal Disorder/Genitopelvic Dysesthesia
This study seeks to provide information regarding the effectiveness of a virtual, synchronous cognitive behavioural therapy (CBT) group program for women with Persistent Genital Arousal Disorder/Genitopelvic Dysesthesia (PGAD/GPD). The program consists of 8 weekly sessions of two hours each, which focus on education and understanding, and learning skills and strategies to manage PGAD/GPD symptoms, and related mental health and lifestyle impacts, as well as structured opportunities for discussion and shared reflection. The group therapy program involves elements based in Cognitive Behavioural Therapy (CBT), Acceptance and Commitment Therapy (ACT), and Dialectical Behaviour Therapy (DBT). Participants in the present study will provide responses to online surveys (before, during, and immediately after treatment, also 3 and 6 months after treatment) regarding their PGAD/GPD symptoms, mental health symptoms, and sexual wellness (sexual pleasure and distress).
- Conditions
- Persistent Genital Arousal Disorder
- Being tested
- Cognitive behavioural therapy
- Keywords
- Persistent Genital Arousal Disorder, intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive behavioural therapyBehavioural
The group therapy program (virtual, synchronous) involves elements based in Cognitive Behavioural Therapy (CBT), Acceptance and Commitment Therapy (ACT), and Dialectical Behaviour Therapy (DBT).
| Study group | Role | What they receive |
|---|---|---|
| Cognitive behavioural therapy | Experimental | The group therapy program (virtual, synchronous) involves elements based in Cognitive Behavioural Therapy (CBT), Acceptance and Commitment Therapy (ACT), and Dialectical Behaviour Therapy (DBT). Receives: Behavioral: Cognitive behavioural therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom intensity
Symptom intensity on a scale of 0 (no symptoms) to 10 (extremely intense symptoms). Range is 0-10. Higher scores are worse.
Measured: Baseline
Symptom intensity
Symptom intensity on a scale of 0 (no symptoms) to 10 (extremely intense symptoms). Range is 0-10. Higher scores are worse.
Measured: Week 1 of program
Symptom intensity
Symptom intensity on a scale of 0 (no symptoms) to 10 (extremely intense symptoms). Range is 0-10. Higher scores are worse.
Measured: Week 2 of program
Symptom intensity
Symptom intensity on a scale of 0 (no symptoms) to 10 (extremely intense symptoms). Range is 0-10. Higher scores are worse.
Measured: Week 3 of program
Symptom intensity
Symptom intensity on a scale of 0 (no symptoms) to 10 (extremely intense symptoms). Range is 0-10. Higher scores are worse.
Measured: Week 4 of program
Symptom intensity
Symptom intensity on a scale of 0 (no symptoms) to 10 (extremely intense symptoms). Range is 0-10. Higher scores are worse.
Measured: Week 5 of program
Symptom intensity
Symptom intensity on a scale of 0 (no symptoms) to 10 (extremely intense symptoms). Range is 0-10. Higher scores are worse.
Measured: Week 6 of program
Symptom intensity
Symptom intensity on a scale of 0 (no symptoms) to 10 (extremely intense symptoms). Range is 0-10. Higher scores are worse.
Measured: Week 7 of program
Symptom intensity
Symptom intensity on a scale of 0 (no symptoms) to 10 (extremely intense symptoms). Range is 0-10. Higher scores are worse.
Measured: Week 8 of program
Symptom intensity
Symptom intensity on a scale of 0 (no symptoms) to 10 (extremely intense symptoms). Range is 0-10. Higher scores are worse.
Measured: 3 months after the end of the program
Symptom intensity
Symptom intensity on a scale of 0 (no symptoms) to 10 (extremely intense symptoms). Range is 0-10. Higher scores are worse.
Measured: 6 months after the end of the program
Symptom distress
Symptom distress on a scale of 0 (no distress) to 10 (extreme distress). Range is 0-10. Higher scores are worse.
Measured: Baseline
Symptom distress
Symptom distress on a scale of 0 (no distress) to 10 (extreme distress). Range is 0-10. Higher scores are worse.
Measured: Week 1 of program
Symptom distress
Symptom distress on a scale of 0 (no distress) to 10 (extreme distress). Range is 0-10. Higher scores are worse.
Measured: Week 2 of program
Symptom distress
Symptom distress on a scale of 0 (no distress) to 10 (extreme distress). Range is 0-10. Higher scores are worse.
Measured: Week 3 of program
Symptom distress
Symptom distress on a scale of 0 (no distress) to 10 (extreme distress). Range is 0-10. Higher scores are worse.
Measured: Week 4 of program
Symptom distress
Symptom distress on a scale of 0 (no distress) to 10 (extreme distress). Range is 0-10. Higher scores are worse.
Measured: Week 5 of program
Symptom distress
Symptom distress on a scale of 0 (no distress) to 10 (extreme distress). Range is 0-10. Higher scores are worse.
Measured: Week 6 of program
Symptom distress
Symptom distress on a scale of 0 (no distress) to 10 (extreme distress). Range is 0-10. Higher scores are worse.
Measured: Week 7 of program
Symptom distress
Symptom distress on a scale of 0 (no distress) to 10 (extreme distress). Range is 0-10. Higher scores are worse.
Measured: Week 8 of program
Symptom distress
Symptom distress on a scale of 0 (no distress) to 10 (extreme distress). Range is 0-10. Higher scores are worse.
Measured: 3 months after the end of the program
Symptom distress
Symptom distress on a scale of 0 (no distress) to 10 (extreme distress). Range is 0-10. Higher scores are worse.
Measured: 6 months after the end of the program
Secondary outcomes (33)
Symptom catastrophizing
Pain Catastrophizing Scale, adapted to symptoms. Range is 0-52. Higher scores are worse.
Measured: Baseline
Symptom catastrophizing
Pain Catastrophizing Scale, adapted to symptoms. Range is 0-52. Higher scores are worse.
Measured: Week 1 of program
Symptom catastrophizing
Pain Catastrophizing Scale, adapted to symptoms. Range is 0-52. Higher scores are worse.
Measured: Week 2 of program
Symptom catastrophizing
Pain Catastrophizing Scale, adapted to symptoms. Range is 0-52. Higher scores are worse.
Measured: Week 3 of program
Symptom catastrophizing
Pain Catastrophizing Scale, adapted to symptoms. Range is 0-52. Higher scores are worse.
Measured: Week 4 of program
Symptom catastrophizing
Pain Catastrophizing Scale, adapted to symptoms. Range is 0-52. Higher scores are worse.
Measured: Week 5 of program
Symptom catastrophizing
Pain Catastrophizing Scale, adapted to symptoms. Range is 0-52. Higher scores are worse.
Measured: Week 6 of program
Symptom catastrophizing
Pain Catastrophizing Scale, adapted to symptoms. Range is 0-52. Higher scores are worse.
Measured: Week 7 of program
Symptom catastrophizing
Pain Catastrophizing Scale, adapted to symptoms. Range is 0-52. Higher scores are worse.
Measured: Week 8 of program
Symptom catastrophizing
Pain Catastrophizing Scale, adapted to symptoms. Range is 0-52. Higher scores are worse.
Measured: 3 months after the end of the program
Symptom catastrophizing
Pain Catastrophizing Scale, adapted to symptoms. Range is 0-52. Higher scores are worse.
Measured: 6 months after the end of the program
Symptom self-efficacy
Pain Self-Efficacy Scale, adapted to symptoms. Range is 0-60. Higher scores are better.
Measured: Baseline
Symptom self-efficacy
Pain Self-Efficacy Scale, adapted to symptoms. Range is 0-60. Higher scores are better.
Measured: Week 1 of program
Symptom self-efficacy
Pain Self-Efficacy Scale, adapted to symptoms. Range is 0-60. Higher scores are better.
Measured: Week 2 of program
Symptom self-efficacy
Pain Self-Efficacy Scale, adapted to symptoms. Range is 0-60. Higher scores are better.
Measured: Week 3 of program
Symptom self-efficacy
Pain Self-Efficacy Scale, adapted to symptoms. Range is 0-60. Higher scores are better.
Measured: Week 4 of program
Symptom self-efficacy
Pain Self-Efficacy Scale, adapted to symptoms. Range is 0-60. Higher scores are better.
Measured: Week 5 of program
Symptom self-efficacy
Pain Self-Efficacy Scale, adapted to symptoms. Range is 0-60. Higher scores are better.
Measured: Week 6 of program
Symptom self-efficacy
Pain Self-Efficacy Scale, adapted to symptoms. Range is 0-60. Higher scores are better.
Measured: Week 7 of program
Symptom self-efficacy
Pain Self-Efficacy Scale, adapted to symptoms. Range is 0-60. Higher scores are better.
Measured: Week 8 of program
Symptom self-efficacy
Pain Self-Efficacy Scale, adapted to symptoms. Range is 0-60. Higher scores are better.
Measured: 3 months after the end of the program
Symptom self-efficacy
Pain Self-Efficacy Scale, adapted to symptoms. Range is 0-60. Higher scores are better.
Measured: 6 months after the end of the program
Resilience
Brief Resilience Scale. Range is 6-30. Higher scores are better.
Measured: Baseline
Resilience
Brief Resilience Scale. Range is 6-30. Higher scores are better.
Measured: Week 1 of program
Resilience
Brief Resilience Scale. Range is 6-30. Higher scores are better.
Measured: Week 2 of program
Resilience
Brief Resilience Scale. Range is 6-30. Higher scores are better.
Measured: Week 3 of program
Resilience
Brief Resilience Scale. Range is 6-30. Higher scores are better.
Measured: Week 4 of program
Resilience
Brief Resilience Scale. Range is 6-30. Higher scores are better.
Measured: Week 5 of program
Resilience
Brief Resilience Scale. Range is 6-30. Higher scores are better.
Measured: Week 6 of program
Resilience
Brief Resilience Scale. Range is 6-30. Higher scores are better.
Measured: Week 7 of program
Resilience
Brief Resilience Scale. Range is 6-30. Higher scores are better.
Measured: Week 8 of program
Resilience
Brief Resilience Scale. Range is 6-30. Higher scores are better.
Measured: 3 months after the end of the program
Resilience
Brief Resilience Scale. Range is 6-30. Higher scores are better.
Measured: 6 months after the end of the program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2023
- Study start24 Apr 2023
- Primary completion31 Aug 2024
- Study completion31 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Persistent Genital Arousal DisorderStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Caroline Pukall
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. Caroline Pukall, Queen's University
- Investigators
- Caroline Pukall, PhD, Principal investigator, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05919784
- Sponsor's protocol ID
- 379631-3
- Status last verified
- Apr 2025
- First submitted
- 13 Jun 2023
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data will be available to other researchers after publication of the results.
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Effectiveness of a Group Cognitive-behavioural Treatment Program for Persistent Genital Arousal Disorder/Genitopelvic Dysesthesia
- ClinicalTrials.gov ID
- NCT05919784
- Acronym / sponsor ID
- 379631-3
- Conditions
- Persistent Genital Arousal Disorder
- Keywords
- Persistent Genital Arousal Disorder, intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Dr. Caroline PukallUniversity, hospital or other
- Study start
- 24 Apr 2023 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 31 May 2025 (actual)
- First posted
- 26 Jun 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.
This study seeks to provide information regarding the effectiveness of a virtual, synchronous cognitive behavioural therapy (CBT) group program for women with Persistent Genital Arousal Disorder/Genitopelvic Dysesthesia (PGAD/GPD). The program consists of 8 weekly sessions of two hours each, which focus on education and understanding, and learning skills and strategies to manage PGAD/GPD symptoms, and related mental health and lifestyle impacts, as well as structured opportunities for discussion and shared reflection. The group therapy program involves elements based in Cognitive Behavioural Therapy (CBT), Acceptance and Commitment Therapy (ACT), and Dialectical Behaviour Therapy (DBT). Participants in the present study will provide responses to online surveys (before, during, and immediately after treatment, also 3 and 6 months after treatment) regarding their PGAD/GPD symptoms, mental health symptoms, and sexual wellness (sexual pleasure and distress).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cognitive behavioural therapy | Experimental | Behavioral: Cognitive behavioural therapyThe group therapy program (virtual, synchronous) involves elements based in Cognitive Behavioural Therapy (CBT), Acceptance and Commitment Therapy (ACT), and Dialectical Behaviour Therapy (DBT). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- at least 18 years of age
- fluent in English
- have a physician-based diagnosis of PGAD/GPD
- reside in Ontario, Canada
- be comfortable answering questions about their health (mental and physical) and sexuality in online surveys
Key exclusion criteria (6 listed)
- under the age of 18 years
- nonfluent in English
- lack of physician based diagnosis of PGAD/GPD
- not comfortable with answering questions about mental, physical, sexual health
- not comfortable with discussing mental and physical health and PGAD/GPD symptoms in group online therapy sessions with video on
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 |
|---|---|---|
| Cognitive behavioural therapyThe group therapy program (virtual, synchronous) involves elements based in Cognitive Behavioural Therapy (CBT), Acceptance and Commitment Therapy (ACT), and Dialectical Behaviour Therapy (DBT). | Behavioural | Cognitive behavioural therapy |
Primary outcome
Symptom intensity
Time frame: Baseline
Symptom intensity on a scale of 0 (no symptoms) to 10 (extremely intense symptoms). Range is 0-10. Higher scores are worse.
Symptom intensity
Time frame: Week 1 of program
Symptom intensity on a scale of 0 (no symptoms) to 10 (extremely intense symptoms). Range is 0-10. Higher scores are worse.
Symptom intensity
Time frame: Week 2 of program
Symptom intensity on a scale of 0 (no symptoms) to 10 (extremely intense symptoms). Range is 0-10. Higher scores are worse.
Symptom intensity
Time frame: Week 3 of program
Symptom intensity on a scale of 0 (no symptoms) to 10 (extremely intense symptoms). Range is 0-10. Higher scores are worse.
Symptom intensity
Time frame: Week 4 of program
Symptom intensity on a scale of 0 (no symptoms) to 10 (extremely intense symptoms). Range is 0-10. Higher scores are worse.
Symptom intensity
Time frame: Week 5 of program
Symptom intensity on a scale of 0 (no symptoms) to 10 (extremely intense symptoms). Range is 0-10. Higher scores are worse.
Symptom intensity
Time frame: Week 6 of program
Symptom intensity on a scale of 0 (no symptoms) to 10 (extremely intense symptoms). Range is 0-10. Higher scores are worse.
Symptom intensity
Time frame: Week 7 of program
Symptom intensity on a scale of 0 (no symptoms) to 10 (extremely intense symptoms). Range is 0-10. Higher scores are worse.
Symptom intensity
Time frame: Week 8 of program
Symptom intensity on a scale of 0 (no symptoms) to 10 (extremely intense symptoms). Range is 0-10. Higher scores are worse.
Symptom intensity
Time frame: 3 months after the end of the program
Symptom intensity on a scale of 0 (no symptoms) to 10 (extremely intense symptoms). Range is 0-10. Higher scores are worse.
Symptom intensity
Time frame: 6 months after the end of the program
Symptom intensity on a scale of 0 (no symptoms) to 10 (extremely intense symptoms). Range is 0-10. Higher scores are worse.
Symptom distress
Time frame: Baseline
Symptom distress on a scale of 0 (no distress) to 10 (extreme distress). Range is 0-10. Higher scores are worse.
Symptom distress
Time frame: Week 1 of program
Symptom distress on a scale of 0 (no distress) to 10 (extreme distress). Range is 0-10. Higher scores are worse.
Symptom distress
Time frame: Week 2 of program
Symptom distress on a scale of 0 (no distress) to 10 (extreme distress). Range is 0-10. Higher scores are worse.
Symptom distress
Time frame: Week 3 of program
Symptom distress on a scale of 0 (no distress) to 10 (extreme distress). Range is 0-10. Higher scores are worse.
Symptom distress
Time frame: Week 4 of program
Symptom distress on a scale of 0 (no distress) to 10 (extreme distress). Range is 0-10. Higher scores are worse.
Symptom distress
Time frame: Week 5 of program
Symptom distress on a scale of 0 (no distress) to 10 (extreme distress). Range is 0-10. Higher scores are worse.
Symptom distress
Time frame: Week 6 of program
Symptom distress on a scale of 0 (no distress) to 10 (extreme distress). Range is 0-10. Higher scores are worse.
Symptom distress
Time frame: Week 7 of program
Symptom distress on a scale of 0 (no distress) to 10 (extreme distress). Range is 0-10. Higher scores are worse.
Symptom distress
Time frame: Week 8 of program
Symptom distress on a scale of 0 (no distress) to 10 (extreme distress). Range is 0-10. Higher scores are worse.
Symptom distress
Time frame: 3 months after the end of the program
Symptom distress on a scale of 0 (no distress) to 10 (extreme distress). Range is 0-10. Higher scores are worse.
Symptom distress
Time frame: 6 months after the end of the program
Symptom distress on a scale of 0 (no distress) to 10 (extreme distress). Range is 0-10. Higher scores are worse.
33 secondary outcomes
Symptom catastrophizing
Time frame: Baseline
Symptom catastrophizing
Time frame: Week 1 of program
Symptom catastrophizing
Time frame: Week 2 of program
Symptom catastrophizing
Time frame: Week 3 of program
Symptom catastrophizing
Time frame: Week 4 of program
Symptom catastrophizing
Time frame: Week 5 of program
Symptom catastrophizing
Time frame: Week 6 of program
Symptom catastrophizing
Time frame: Week 7 of program
Symptom catastrophizing
Time frame: Week 8 of program
Symptom catastrophizing
Time frame: 3 months after the end of the program
Symptom catastrophizing
Time frame: 6 months after the end of the program
Symptom self-efficacy
Time frame: Baseline
Symptom self-efficacy
Time frame: Week 1 of program
Symptom self-efficacy
Time frame: Week 2 of program
Symptom self-efficacy
Time frame: Week 3 of program
Symptom self-efficacy
Time frame: Week 4 of program
Symptom self-efficacy
Time frame: Week 5 of program
Symptom self-efficacy
Time frame: Week 6 of program
Symptom self-efficacy
Time frame: Week 7 of program
Symptom self-efficacy
Time frame: Week 8 of program
Symptom self-efficacy
Time frame: 3 months after the end of the program
Symptom self-efficacy
Time frame: 6 months after the end of the program
Resilience
Time frame: Baseline
Resilience
Time frame: Week 1 of program
Resilience
Time frame: Week 2 of program
Resilience
Time frame: Week 3 of program
Resilience
Time frame: Week 4 of program
Resilience
Time frame: Week 5 of program
Resilience
Time frame: Week 6 of program
Resilience
Time frame: Week 7 of program
Resilience
Time frame: Week 8 of program
Resilience
Time frame: 3 months after the end of the program
Resilience
Time frame: 6 months after the end of the program
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 May 2026.
- Individual participant dataSharing planned: Yes. De-identified data will be available to other researchers after publication of the results.
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.
Caroline Pukall, PhD principal investigator
Queen's University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive behavioural therapy in people with Persistent Genital Arousal Disorder, run by Dr. Caroline Pukall at 1 site in Canada.
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 6 inclusion and 6 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 May 2026. 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 Canada. 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.
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?
Symptom intensity (time frame: Baseline). The study lists 22 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 6 May 2026.