Pelvic Floor Muscle WeaknessNCT07119476
Does Hip Strength Impact Active Females Rate of Pelvic Floor Dysfunction? The Primary Goal of This Research is to Collect Data on Hip Strength for Active Females and Assess if There is a Relationship Between Hip Strength and Pelvic Floor Dysfunction (PFD).
An observational study of Pelvic Floor Muscle Weakness and Pelvic Floor Disorder, run by George Fox University at 1 site in United States.
Trial summary
The primary goal of this research is to collect data on hip strength for active females and assess if there is a relationship between hip strength and pelvic floor dysfunction (PFD). Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pelvic Floor Muscle Weakness, Pelvic Floor Disorder, Pelvic Pain
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Nov 2024to 24 Feb 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: 18-45 year old females who are active as described by the WHO.
Who may be able to join
- Age range 18-45 years
- Female gender
- Patients can either have no pelvic floor symptoms, current pelvic floor dysfunction (relaxing or nonrelaxing), or current musculoskeletal pain.
- Participants must be physically active as defined by the World Health Organization (WHO) as performing 150-300 minutes of moderate-intensity aerobic physical activity or at least 75-150 minutes of vigorous-intensity aerobic physical activity; or an equivalent combination of moderate- and vigorous-intensity activity throughout the week.
Who cannot join
- Pregnancy
- Gynecological or Obstetric Surgery within 6 months
- Active infection (including Sexually Transmitted Infection, Pelvic, Urinary Tract Infection (UTI), Yeast)
- Cancer
- Inflammatory Disease
- Connective Tissue Disease
- Or have been instructed by a Healthcare provider to not participate
Trial locations and contacts
1 site in 1 country.
United States1 site
George Fox University Medical Sciences Building
Newberg, Oregon, 97132
About this study
Official title: Does Hip Strength Impact Active Females Rate of Pelvic Floor Dysfunction?
The primary goal of this research is to collect data on hip strength for active females and assess if there is a relationship between hip strength and pelvic floor dysfunction (PFD). The participants will fill out a REDCap questionnaire that includes informed consent, demographics, injury history, history of PFD and/or hip pain, characteristics of physical activity and/or sport(s), knowledge of pelvic floor musculature, and questions regarding the correlation between PFD and performance. Additionally, Patient Reported Outcomes Measurement Information System (PROMIS) surveys assessing anxiety and depression will be included. After completing the questionnaires, a one time hip strength assessment will be performed in four directions on each hip and the evaluator will be blinded to their results. Foster et al researched hip and pelvic floor strength in a different patient population (Urgency and Frequency prominent lower urinary tract symptoms) in 2021 with 18-60 year olds and did not have a classification for level of physical activity. This research group found that there was a reduction in hip external rotation and abduction strength compared to case controls. To this point, there has not been any research assessing the relationship between hip strength and relaxing versus nonrelaxing pelvic floor dysfunction and controls.
Read the detailed description
Women who participate in high-level physical activity are known to have increased rates of Urinary Incontinence (UI) with prevalence rates of 28-29.6% compared to non-athletes with rates of 9.8-13.4%. The current body of research for active females in pelvic health physical therapy has focused primarily on female athletes with Urinary Incontinence (UI), which is only one symptom under the greater umbrella of Pelvic Floor Dysfunction (PFD). Likewise, systematic reviews of females with PFD have been limited to the exploration of Female UI. Pelvic Floor Dysfunction can be separated into two broad categories: relaxing and nonrelaxing. Relaxing PFD conditions are more common and include diagnoses of UI and prolapse of pelvic structures. Nonrelaxing PFD can include a broad range of non-specific symptoms. These symptoms can include voiding, anorectal, and sexual dysfunction and pain. Specifically, the pain can be insertional or deep dyspareunia, low back pain that can radiate to the thighs or groin, and pelvic pain that may be unrelated to intercourse or may occur after intercourse. Voiding issues may include a sense of incomplete emptying, bladder pain, urinary frequency, urgency or dysuria.
Research related to nonrelaxing pelvic floor dysfunction has been mostly limited to a case example, a case study related to dry needling intervention and a continuing education formatted article from Mayo Clinic. Nonrelaxing PFD has been described as a disorder where "..the muscles of the pelvic floor remain in a contracted state causing increased pressure and pain." From these articles, nonrelaxing PFD can present with a wide range of nonspecific symptoms and can negatively affect quality of life.
An additional area of interest is the impact of anxiety and depression on pelvic floor dysfunction of active females. Anxiety and depression symptoms are common in individuals with PFD (30.9% and 20.3% respectively) and athletes. High performance athletes have depression rates ranging from 6.7% to 34.0% with risk factors including female gender and playing an individual sport. In a systematic review, Beisecker et al explored depression, anxiety and stress among student athletes and found specific themes related to these symptoms, including being a female student athlete, social support, connection and interaction and health components (diet and eating patterns, sleep and alcohol use).
Foster et al researched hip and pelvic floor strength in a different patient population (Urgency and Frequency prominent lower urinary tract symptoms) in 2021 with 18-60 year olds and did not have a classification for level of physical activity. This research group found that there was a reduction in hip external rotation and abduction strength compared to case controls. To this point, there has not been any research assessing the relationship between hip strength and relaxing versus nonrelaxing pelvic floor dysfunction.
I plan to make this work public through submission to the Journal of Women's Health Physical Therapy or the Journal of Orthopaedic \& Sports Physical Therapy. Additionally, I will submit my findings to the American Physical Therapy Association Combined Section Meeting for platform presentation.
- Keywords
- pelvic health, active female, pelvic floor dysfunction
- Medical subject headings
- Pelvic Floor Disorders, Pelvic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Active Females | Active Females Ages 18-45 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inline Tension Dynamometer: Hip Strength Assessment
The hip strength assessment will be performed in person and will include four strength assessments (hip abduction, hip adduction, hip external rotation and hip internal rotation) for each lower extremity.
Measured: Baseline (one time assessment)
International Consensus on Incontinence Questionnaire (ICIQ-FLUTS Long Form)
a questionnaire that evaluates female lower urinary tract symptoms and quality of life in clinical practice and research. This questionnaire has been found to be valid, reliable, and responsive. The time required to complete this questionnaire is 4-5 minutes.
This scale is 0-48 where all subscale scores are added and higher scores indicate greater impact of individual symptoms for the patient.
Measured: Baseline (one time assessment)
Patient Reported Outcome Measure Information System (PROMIS)
PROMIS Anxiety- CAT that focuses on fear (fearfulness, panic), anxious misery (worry, dread), hyperarousal (tension, nervousness, restlessness), and somatic symptoms related to arousal (racing heart, dizziness).
The scale is between 8 and 40 raw score and is converted into a t score metric and a higher score indicates greater levels of anxiety. A score of 50 represents the average and a standard deviation (SD) of 10.
PROMIS Depression- CAT that focuses on negative mood (sadness, guilt), views of self (self-criticism, worthlessness), and social cognition (loneliness, interpersonal alienation), as well as decreased positive affect and engagement (loss of interest, meaning, and purpose).
The scale is between 8 and 40 raw score and is converted into a t score metric and a higher score indicates greater levels of depression. A score of 50 represents the average and a standard deviation (SD) of 10.
Measured: Baseline (one time assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2025
- Study start11 Nov 2024
- Primary completion24 Feb 2025
- Study completion24 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Pelvic Floor Muscle WeaknessStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 55 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- George Fox University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tess Treinen Swake, George Fox University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07119476
- Sponsor's protocol ID
- 2241059
- Status last verified
- Aug 2025
- First submitted
- 30 Jul 2025
- Last updated
- 13 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Beisecker L, Harrison P, Josephson M, DeFreese JD. Depression, anxiety and stress among female student-athletes: a systematic review and meta-analysis. Br J Sports Med. 2024 Mar 8;58(5):278-285. doi: 10.1136/bjsports-2023-107328.
PubMed 38233087Vrijens D, Berghmans B, Nieman F, van Os J, van Koeveringe G, Leue C. Prevalence of anxiety and depressive symptoms and their association with pelvic floor dysfunctions-A cross sectional cohort study at a Pelvic Care Centre. Neurourol Urodyn. 2017 Sep;36(7):1816-1823. doi: 10.1002/nau.23186. Epub 2017 Feb 21.
PubMed 28220586Sheikhhoseini R, Arab AM. Dry Needling in myofascial tracks in Non-Relaxing Pelvic Floor Dysfunction: A case study. J Bodyw Mov Ther. 2018 Apr;22(2):337-340. doi: 10.1016/j.jbmt.2017.09.016. Epub 2017 Sep 25.
PubMed 29861229Louis-Charles K, Biggie K, Wolfinbarger A, Wilcox B, Kienstra CM. Pelvic Floor Dysfunction in the Female Athlete. Curr Sports Med Rep. 2019 Feb;18(2):49-52. doi: 10.1249/JSR.0000000000000563.
PubMed 30730341Faubion SS, Shuster LT, Bharucha AE. Recognition and management of nonrelaxing pelvic floor dysfunction. Mayo Clin Proc. 2012 Feb;87(2):187-93. doi: 10.1016/j.mayocp.2011.09.004.
PubMed 22305030Almousa S, Bandin van Loon A. The prevalence of urinary incontinence in nulliparous adolescent and middle-aged women and the associated risk factors: A systematic review. Maturitas. 2018 Jan;107:78-83. doi: 10.1016/j.maturitas.2017.10.003. Epub 2017 Oct 7.
PubMed 29169586de Mattos Lourenco TR, Matsuoka PK, Baracat EC, Haddad JM. Urinary incontinence in female athletes: a systematic review. Int Urogynecol J. 2018 Dec;29(12):1757-1763. doi: 10.1007/s00192-018-3629-z. Epub 2018 Mar 19.
PubMed 29552736Sorrigueta-Hernandez A, Padilla-Fernandez BY, Marquez-Sanchez MT, Flores-Fraile MC, Flores-Fraile J, Moreno-Pascual C, Lorenzo-Gomez A, Garcia-Cenador MB, Lorenzo-Gomez MF. Benefits of Physiotherapy on Urinary Incontinence in High-Performance Female Athletes. Meta-Analysis. J Clin Med. 2020 Oct 10;9(10):3240. doi: 10.3390/jcm9103240.
PubMed 33050442Foster SN, Spitznagle TM, Tuttle LJ, Sutcliffe S, Steger-May K, Lowder JL, Meister MR, Ghetti C, Wang J, Mueller MJ, Harris-Hayes M. Hip and Pelvic Floor Muscle Strength in Women with and without Urgency and Frequency Predominant Lower Urinary Tract Symptoms. J Womens Health Phys Therap. 2021 Jul-Sep;45(3):126-134. doi: 10.1097/jwh.0000000000000209.
PubMed 34366727
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Hip Strength Impact Active Females Rate of Pelvic Floor Dysfunction?
- ClinicalTrials.gov ID
- NCT07119476
- Acronym / sponsor ID
- 2241059
- Keywords
- pelvic health, active female, pelvic floor dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- George Fox UniversityUniversity, hospital or other
- Study start
- 11 Nov 2024 (actual)
- Primary completion
- 24 Feb 2025 (actual)
- Study completion
- 24 Feb 2025 (actual)
- First posted
- 13 Aug 2025 (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 primary goal of this research is to collect data on hip strength for active females and assess if there is a relationship between hip strength and pelvic floor dysfunction (PFD). The participants will fill out a REDCap questionnaire that includes informed consent, demographics, injury history, history of PFD and/or hip pain, characteristics of physical activity and/or sport(s), knowledge of pelvic floor musculature, and questions regarding the correlation between PFD and performance. Additionally, Patient Reported Outcomes Measurement Information System (PROMIS) surveys assessing anxiety and depression will be included. After completing the questionnaires, a one time hip strength assessment will be performed in four directions on each hip and the evaluator will be blinded to their results. Foster et al researched hip and pelvic floor strength in a different patient population (Urgency and Frequency prominent lower urinary tract symptoms) in 2021 with 18-60 year olds and did not have a classification for level of physical activity. This research group found that there was a reduction in hip external rotation and abduction strength compared to case controls. To this point, there has not been any research assessing the relationship between hip strength and relaxing versus nonrelaxing pelvic floor dysfunction and controls.
Detailed description
Women who participate in high-level physical activity are known to have increased rates of Urinary Incontinence (UI) with prevalence rates of 28-29.6% compared to non-athletes with rates of 9.8-13.4%. The current body of research for active females in pelvic health physical therapy has focused primarily on female athletes with Urinary Incontinence (UI), which is only one symptom under the greater umbrella of Pelvic Floor Dysfunction (PFD). Likewise, systematic reviews of females with PFD have been limited to the exploration of Female UI. Pelvic Floor Dysfunction can be separated into two broad categories: relaxing and nonrelaxing. Relaxing PFD conditions are more common and include diagnoses of UI and prolapse of pelvic structures. Nonrelaxing PFD can include a broad range of non-specific symptoms. These symptoms can include voiding, anorectal, and sexual dysfunction and pain. Specifically, the pain can be insertional or deep dyspareunia, low back pain that can radiate to the thighs or groin, and pelvic pain that may be unrelated to intercourse or may occur after intercourse. Voiding issues may include a sense of incomplete emptying, bladder pain, urinary frequency, urgency or dysuria.
Research related to nonrelaxing pelvic floor dysfunction has been mostly limited to a case example, a case study related to dry needling intervention and a continuing education formatted article from Mayo Clinic. Nonrelaxing PFD has been described as a disorder where "..the muscles of the pelvic floor remain in a contracted state causing increased pressure and pain." From these articles, nonrelaxing PFD can present with a wide range of nonspecific symptoms and can negatively affect quality of life.
An additional area of interest is the impact of anxiety and depression on pelvic floor dysfunction of active females. Anxiety and depression symptoms are common in individuals with PFD (30.9% and 20.3% respectively) and athletes. High performance athletes have depression rates ranging from 6.7% to 34.0% with risk factors including female gender and playing an individual sport. In a systematic review, Beisecker et al explored depression, anxiety and stress among student athletes and found specific themes related to these symptoms, including being a female student athlete, social support, connection and interaction and health components (diet and eating patterns, sleep and alcohol use).
Foster et al researched hip and pelvic floor strength in a different patient population (Urgency and Frequency prominent lower urinary tract symptoms) in 2021 with 18-60 year olds and did not have a classification for level of physical activity. This research group found that there was a reduction in hip external rotation and abduction strength compared to case controls. To this point, there has not been any research assessing the relationship between hip strength and relaxing versus nonrelaxing pelvic floor dysfunction.
I plan to make this work public through submission to the Journal of Women's Health Physical Therapy or the Journal of Orthopaedic \& Sports Physical Therapy. Additionally, I will submit my findings to the American Physical Therapy Association Combined Section Meeting for platform presentation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active Females | – | –Active Females Ages 18-45 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 18-45 year old females who are active as described by the WHO.
Key inclusion criteria (4 listed)
- Age range 18-45 years
- Female gender
- Patients can either have no pelvic floor symptoms, current pelvic floor dysfunction (relaxing or nonrelaxing), or current musculoskeletal pain.
- Participants must be physically active as defined by the World Health Organization (WHO) as performing 150-300 minutes of moderate-intensity aerobic physical activity or at least 75-150 minutes of vigorous-intensity aerobic physical activity; or an equivalent combination of moderate- and vigorous-intensity activity throughout the week.
Key exclusion criteria (7 listed)
- Pregnancy
- Gynecological or Obstetric Surgery within 6 months
- Active infection (including Sexually Transmitted Infection, Pelvic, Urinary Tract Infection (UTI), Yeast)
- Cancer
- Inflammatory Disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Inline Tension Dynamometer: Hip Strength Assessment
Time frame: Baseline (one time assessment)
The hip strength assessment will be performed in person and will include four strength assessments (hip abduction, hip adduction, hip external rotation and hip internal rotation) for each lower extremity.
International Consensus on Incontinence Questionnaire (ICIQ-FLUTS Long Form)
Time frame: Baseline (one time assessment)
a questionnaire that evaluates female lower urinary tract symptoms and quality of life in clinical practice and research. This questionnaire has been found to be valid, reliable, and responsive. The time required to complete this questionnaire is 4-5 minutes. This scale is 0-48 where all subscale scores are added and higher scores indicate greater impact of individual symptoms for the patient.
Patient Reported Outcome Measure Information System (PROMIS)
Time frame: Baseline (one time assessment)
PROMIS Anxiety- CAT that focuses on fear (fearfulness, panic), anxious misery (worry, dread), hyperarousal (tension, nervousness, restlessness), and somatic symptoms related to arousal (racing heart, dizziness). The scale is between 8 and 40 raw score and is converted into a t score metric and a higher score indicates greater levels of anxiety. A score of 50 represents the average and a standard deviation (SD) of 10. PROMIS Depression- CAT that focuses on negative mood (sadness, guilt), views of self (self-criticism, worthlessness), and social cognition (loneliness, interpersonal alienation), as well as decreased positive affect and engagement (loss of interest, meaning, and purpose). The scale is between 8 and 40 raw score and is converted into a t score metric and a higher score indicates greater levels of depression. A score of 50 represents the average and a standard deviation (SD) of 10.
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 13 Aug 2025.
- Background: PubMed 38233087Beisecker L, Harrison P, Josephson M, DeFreese JD. Depression, anxiety and stress among female student-athletes: a systematic review and meta-analysis. Br J Sports Med. 2024 Mar 8;58(5):278-285. doi: 10.1136/bjsports-2023-107328.
- Background: PubMed 28220586Vrijens D, Berghmans B, Nieman F, van Os J, van Koeveringe G, Leue C. Prevalence of anxiety and depressive symptoms and their association with pelvic floor dysfunctions-A cross sectional cohort study at a Pelvic Care Centre. Neurourol Urodyn. 2017 Sep;36(7):1816-1823. doi: 10.1002/nau.23186. Epub 2017 Feb 21.
- Background: PubMed 29861229Sheikhhoseini R, Arab AM. Dry Needling in myofascial tracks in Non-Relaxing Pelvic Floor Dysfunction: A case study. J Bodyw Mov Ther. 2018 Apr;22(2):337-340. doi: 10.1016/j.jbmt.2017.09.016. Epub 2017 Sep 25.
- Background: PubMed 30730341Louis-Charles K, Biggie K, Wolfinbarger A, Wilcox B, Kienstra CM. Pelvic Floor Dysfunction in the Female Athlete. Curr Sports Med Rep. 2019 Feb;18(2):49-52. doi: 10.1249/JSR.0000000000000563.
- Background: PubMed 22305030Faubion SS, Shuster LT, Bharucha AE. Recognition and management of nonrelaxing pelvic floor dysfunction. Mayo Clin Proc. 2012 Feb;87(2):187-93. doi: 10.1016/j.mayocp.2011.09.004.
- Background: PubMed 29169586Almousa S, Bandin van Loon A. The prevalence of urinary incontinence in nulliparous adolescent and middle-aged women and the associated risk factors: A systematic review. Maturitas. 2018 Jan;107:78-83. doi: 10.1016/j.maturitas.2017.10.003. Epub 2017 Oct 7.
- Background: PubMed 29552736de Mattos Lourenco TR, Matsuoka PK, Baracat EC, Haddad JM. Urinary incontinence in female athletes: a systematic review. Int Urogynecol J. 2018 Dec;29(12):1757-1763. doi: 10.1007/s00192-018-3629-z. Epub 2018 Mar 19.
- Background: PubMed 33050442Sorrigueta-Hernandez A, Padilla-Fernandez BY, Marquez-Sanchez MT, Flores-Fraile MC, Flores-Fraile J, Moreno-Pascual C, Lorenzo-Gomez A, Garcia-Cenador MB, Lorenzo-Gomez MF. Benefits of Physiotherapy on Urinary Incontinence in High-Performance Female Athletes. Meta-Analysis. J Clin Med. 2020 Oct 10;9(10):3240. doi: 10.3390/jcm9103240.
- Background: PubMed 34366727Foster SN, Spitznagle TM, Tuttle LJ, Sutcliffe S, Steger-May K, Lowder JL, Meister MR, Ghetti C, Wang J, Mueller MJ, Harris-Hayes M. Hip and Pelvic Floor Muscle Strength in Women with and without Urgency and Frequency Predominant Lower Urinary Tract Symptoms. J Womens Health Phys Therap. 2021 Jul-Sep;45(3):126-134. doi: 10.1097/jwh.0000000000000209.
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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?
An observational study of Pelvic Floor Muscle Weakness and Pelvic Floor Disorder, run by George Fox University at 1 site 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 4 inclusion and 7 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 13 Aug 2025. 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 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.
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?
Inline Tension Dynamometer: Hip Strength Assessment (time frame: Baseline (one time assessment)). 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?
On the ClinicalTrials.gov record for NCT07119476, which also lists 9 linked publications.
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 13 Aug 2025.