PCOS (Polycystic Ovary Syndrome) of Bilateral OvariesGEMS-PCOSNCT06050265
Glucose Evaluation Through Continuous Glucose Monitors in Polycystic Ovary Syndrome
A study testing DEXCOM Continuous Glucose Monitor (CGM) in people with PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries and Dysglycemia, run by University of California, San Francisco at 1 site in United States.
Trial summary
PCOS is the most common endocrine disorder of reproductive aged women. In addition to menstrual and endocrine abnormalities, PCOS is characterized by insulin resistance and glycemic dysregulation. 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
- PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries, Dysglycemia, Insulin Resistance
- What is being tested?
- DEXCOM Continuous Glucose Monitor (CGM)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Nov 2023to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- For aim 1:
- Aged 18-45
- Female sex
- Agree to wear a CGM for 10 days
- Have access to an apple or android smart phone for CGM monitoring
- Are able to be characterized as PCOS or non-PCOS using the 2003 Rotterdam criteria for PCOS of 2 or more of the following: 1) biochemical or clinical hyperandrogenism, 2) polycystic ovarian morphology on transvaginal ultrasound, and/or 3) oligo-amenorrhea
Show all 10Show fewer
- For aim 2:
- All of the inclusion criteria for aim 1
- Meet 2003 Rotterdam criteria for PCOS as above
- Evidence of baseline glycemic dysregulation including any of the following: 1) elevated fasting glucose (100-125 mg/dL), 2) elevated 2 hour glucose (140-200 mg/dL), 3) elevated fasting insulin (>10 mIU/mL), 4) elevated 2 hour insulin (>40 mIU/mL), 5) elevated Hgba1c (5.7- 6.4)
Who cannot join
- For both aims 1 and 2:
- Use of metformin or other anti-diabetic agents
- Diagnosis of type I or II diabetes mellitus (including those found to have fasting glucose >126, 2 hour glucose >200, Hgba1c >6.5)
- Prior or current use of CGM
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSF Center for Reproductive Health
San Francisco, California, 94158
About this study
PCOS is the most common endocrine disorder of reproductive aged women. In addition to menstrual and endocrine abnormalities, PCOS is characterized by insulin resistance and glycemic dysregulation. The pattern of glycemic abnormalities among patients with PCOS may be different than the general population, as evidenced by invasive, time consuming, and costly procedures such as the euglycemic clamp or oral glucose tolerance test. Continuous glucose monitoring (CGM) offers an opportunity to evaluate glycemic status in real world conditions. Furthermore, use of a CGM has been found to improve glycemic status among those with prediabetes and diabetes, but little is known about utility among patients with PCOS. The investigators thus seek to 1) characterize glycemic status using CGM among patients with PCOS and 2) assess the impact of CGM use on metabolic and reproductive health in patients with PCOS.
Read the detailed description
Study synopsis:
Recruitment:
- PCOS participants will be recruited from those who are being seen or have previously been seen at the UCSF multidisciplinary PCOS clinic.
- Non-PCOS participants will be recruited from patients being seen at the UCSF Center for Reproductive Health for other clinical evaluations or research projects.
Study protocol:
Aim 1:
Pre-DEXCOM evaluation:
PCOS participants:
- As part of routine clinical care all PCOS participants will have had the following procedures completed:
- Blood work for fasting and 2 hour glucose/insulin, hgba1c, CRP, lipid panel, liver enzymes, SHBG, free and total testosterone, DHEAS, androstenedione, 17-OH-Progesterone, prolactin, TSH, FSH, LH, E2, estrone, Vit D.
- Screening questionnaires on physical exercise using validated International Physical Activity Questionnaire
- In person clinical evaluation including physical exam and history.
- In person transvaginal ultrasound assessment.
- The above are part of standard of care screening for patients with concern for PCOS and are currently routinely completed at the UCSF Center for Reproductive Health in this setting.
- Participants will also be asked to complete a 10 question validated fatigue assessment scale (FAS)
Non-PCOS participants:
- Participants will have blood work for fasting and 2 hour glucose/insulin, hgba1c, CRP, lipid panel, liver enzymes, SHBG, free and total testosterone, DHEAS, androstenedione, 17-OH- Progesterone, prolactin, TSH, FSH, LH, E2, estrone, Vit D obtained.
- Screening questionnaires on physical exercise using validated International Physical Activity Questionnaire will be obtained.
- Participants will be asked to complete the same intake questionnaires that PCOS participants complete as part of standard of care practices in the UCSF multidisciplinary PCOS clinic, which include questions on ethnicity, family, medical, and social history.
- If blood work was not completed as part of standard of care for routine clinical evaluation or as part of a previously completed research study in which the patient provided consent for their data to be used in other trials, the above labs will be collected and paid for by the research protocol.
- Participants will also be asked to complete a 10 question validated fatigue assessment scale (FAS)
Procedures:
DEXCOM evaluation:
- PCOS and non-PCOS participants will be given a DEXCOM CGM to wear for 10 days. During this time they will be blinded to the results of the DEXCOM.
- Participants will be asked to complete the automated self-administered 24-hour dietary assessment (ASA24) tool, which is a web based, validated 24 hour dietary record program, produced by the National Cancer Institute (NCI)/Nation Institute of Health and made available free of charge to researchers.
- As part of the ASA24 participants will also be asked about their sleep quality the night prior to their dietary record. See attached module.
- All participants will be asked to complete the ASA24 during a 24 hour period while wearing the CGM.
Aim 2:
Recruitment:
- From those participants with PCOS recruited for Aim 1, a subgroup with evidence of dysglycemia (as outlined in the inclusion criteria) will be recruited for aim 2.
- Participants will be randomized in a 3:1 fashion to intervention with CGM vs control.
Procedures:
Intervention group:
- All participants will receive standard of care nutrition and exercise advice from a trained registered dietician.
- Participants randomized to the intervention arm will also receive education on how to use and monitor blood glucose using the DEXCOM G7 CGM and associated phone application.
- Participants will be asked to use a CGM continuously for 90 days.
- After 90 days blood work for fasting and 2 hour glucose/insulin, hgba1c, CRP, lipid panel, liver enzymes, SHBG, free and total testosterone, DHEAS, androstenedione, 17-OH-Progesterone, prolactin, TSH, FSH, LH, E2, estrone, Vit D will be obtained.
- After 90 days participants will also be asked to repeat a 10 question validated fatigue assessment scale (FAS)
- After 90 days participants will be asked about their menstrual cycle pattern over the 90 day period
Control group:
- All participants will receive standard of care nutrition and exercise advice from a trained registered dietician.
- After 90 days blood work for fasting and 2 hour glucose/insulin, hgba1c, CRP, lipid panel, liver enzymes, SHBG, free and total testosterone, DHEAS, androstenedione, 17-OH-Progesterone, prolactin, TSH, FSH, LH, E2, estrone, Vit D will be obtained.
- After 90 days, participants in the control group will be given the opportunity to receive CGM devices to monitor blood glucose up to 30 days with education on how to use the device and associated phone application to monitor blood glucose.
- After 90 days participants will also be asked to repeat a 10 question validated fatigue assessment scale (FAS)
- After 90 days participants will be asked about their menstrual cycle pattern over the 90 day period
Data Management:
Clinical and laboratory data will be stored in a Research Electronic Data Capture (REDCap) system designed by Dr. Huddleston and research staff. Fields will be designed by study coordinators with input from key investigators. Our team has extensive experience with REDCap architecture and utilization.
- Being tested
- DEXCOM Continuous Glucose Monitor (CGM)
- Keywords
- continuous glucose monitor
- Medical subject headings
- Polycystic Ovary Syndrome, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DEXCOM Continuous Glucose Monitor (CGM)Device
Dexcom CGMs are placed every 10 days and provide a continuous assessment of blood glucose.
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm - CGM | Experimental | Participants randomized to intervention arm will be given standard of care nutrition and exercise counseling to optimize weight, nutrition and glycemic status AND will be asked to wear a DEXCOM CGM for 90 days. Receives: Device: DEXCOM Continuous Glucose Monitor (CGM) |
| Control arm | No intervention | Participants randomized to control arm will ONLY be given standard of care nutrition and exercise counseling to optimize weight, nutrition and glycemic status. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between change in hemoglobin A1C
Difference between change in hemoglobin A1C for 2 treatment arms from baseline to after 90 days
Measured: 90 days
Secondary outcomes (1)
Difference between change in fasting insulin
Difference between change in fasting insulin for 2 treatment arms from baseline to after 90 days
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2023
- Study start29 Nov 2023
- Primary completion12 Jul 2025
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PCOS (Polycystic Ovary Syndrome) of Bilateral OvariesStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- DexCom, Inc.
- Responsible party
- Sponsor
- Investigators
- Heather G Huddleston, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06050265
- Sponsor's protocol ID
- 23-39852
- Acronym
- GEMS-PCOS
- Status last verified
- Jun 2026
- First submitted
- 15 Sep 2023
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Tatulashvili S, Baptiste Julla J, Sritharan N, Rezgani I, Levy V, Bihan H, Riveline JP, Cosson E. Ambulatory Glucose Profile According to Different Phases of the Menstrual Cycle in Women Living With Type 1 Diabetes. J Clin Endocrinol Metab. 2022 Sep 28;107(10):2793-2800. doi: 10.1210/clinem/dgac443.
PubMed 35869507Legro RS, Castracane VD, Kauffman RP. Detecting insulin resistance in polycystic ovary syndrome: purposes and pitfalls. Obstet Gynecol Surv. 2004 Feb;59(2):141-54. doi: 10.1097/01.OGX.0000109523.25076.E2.
PubMed 14752302Diamanti-Kandarakis E, Dunaif A. Insulin resistance and the polycystic ovary syndrome revisited: an update on mechanisms and implications. Endocr Rev. 2012 Dec;33(6):981-1030. doi: 10.1210/er.2011-1034. Epub 2012 Oct 12.
PubMed 23065822
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glucose Evaluation Through Continuous Glucose Monitors in Polycystic Ovary Syndrome
- ClinicalTrials.gov ID
- NCT06050265
- Acronym / sponsor ID
- GEMS-PCOS / 23-39852
- Keywords
- continuous glucose monitor
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- DexCom, Inc.
- Study start
- 29 Nov 2023 (actual)
- Primary completion
- 12 Jul 2025 (actual)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 22 Sep 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.
PCOS is the most common endocrine disorder of reproductive aged women. In addition to menstrual and endocrine abnormalities, PCOS is characterized by insulin resistance and glycemic dysregulation. The pattern of glycemic abnormalities among patients with PCOS may be different than the general population, as evidenced by invasive, time consuming, and costly procedures such as the euglycemic clamp or oral glucose tolerance test. Continuous glucose monitoring (CGM) offers an opportunity to evaluate glycemic status in real world conditions. Furthermore, use of a CGM has been found to improve glycemic status among those with prediabetes and diabetes, but little is known about utility among patients with PCOS. The investigators thus seek to 1) characterize glycemic status using CGM among patients with PCOS and 2) assess the impact of CGM use on metabolic and reproductive health in patients with PCOS.
Detailed description
Study synopsis:
Recruitment:
- PCOS participants will be recruited from those who are being seen or have previously been seen at the UCSF multidisciplinary PCOS clinic.
- Non-PCOS participants will be recruited from patients being seen at the UCSF Center for Reproductive Health for other clinical evaluations or research projects.
Study protocol:
Aim 1:
Pre-DEXCOM evaluation:
PCOS participants:
- As part of routine clinical care all PCOS participants will have had the following procedures completed:
- Blood work for fasting and 2 hour glucose/insulin, hgba1c, CRP, lipid panel, liver enzymes, SHBG, free and total testosterone, DHEAS, androstenedione, 17-OH-Progesterone, prolactin, TSH, FSH, LH, E2, estrone, Vit D.
- Screening questionnaires on physical exercise using validated International Physical Activity Questionnaire
- In person clinical evaluation including physical exam and history.
- In person transvaginal ultrasound assessment.
- The above are part of standard of care screening for patients with concern for PCOS and are currently routinely completed at the UCSF Center for Reproductive Health in this setting.
- Participants will also be asked to complete a 10 question validated fatigue assessment scale (FAS)
Non-PCOS participants:
- Participants will have blood work for fasting and 2 hour glucose/insulin, hgba1c, CRP, lipid panel, liver enzymes, SHBG, free and total testosterone, DHEAS, androstenedione, 17-OH- Progesterone, prolactin, TSH, FSH, LH, E2, estrone, Vit D obtained.
- Screening questionnaires on physical exercise using validated International Physical Activity Questionnaire will be obtained.
- Participants will be asked to complete the same intake questionnaires that PCOS participants complete as part of standard of care practices in the UCSF multidisciplinary PCOS clinic, which include questions on ethnicity, family, medical, and social history.
- If blood work was not completed as part of standard of care for routine clinical evaluation or as part of a previously completed research study in which the patient provided consent for their data to be used in other trials, the above labs will be collected and paid for by the research protocol.
- Participants will also be asked to complete a 10 question validated fatigue assessment scale (FAS)
Procedures:
DEXCOM evaluation:
- PCOS and non-PCOS participants will be given a DEXCOM CGM to wear for 10 days. During this time they will be blinded to the results of the DEXCOM.
- Participants will be asked to complete the automated self-administered 24-hour dietary assessment (ASA24) tool, which is a web based, validated 24 hour dietary record program, produced by the National Cancer Institute (NCI)/Nation Institute of Health and made available free of charge to researchers.
- As part of the ASA24 participants will also be asked about their sleep quality the night prior to their dietary record. See attached module.
- All participants will be asked to complete the ASA24 during a 24 hour period while wearing the CGM.
Aim 2:
Recruitment:
- From those participants with PCOS recruited for Aim 1, a subgroup with evidence of dysglycemia (as outlined in the inclusion criteria) will be recruited for aim 2.
- Participants will be randomized in a 3:1 fashion to intervention with CGM vs control.
Procedures:
Intervention group:
- All participants will receive standard of care nutrition and exercise advice from a trained registered dietician.
- Participants randomized to the intervention arm will also receive education on how to use and monitor blood glucose using the DEXCOM G7 CGM and associated phone application.
- Participants will be asked to use a CGM continuously for 90 days.
- After 90 days blood work for fasting and 2 hour glucose/insulin, hgba1c, CRP, lipid panel, liver enzymes, SHBG, free and total testosterone, DHEAS, androstenedione, 17-OH-Progesterone, prolactin, TSH, FSH, LH, E2, estrone, Vit D will be obtained.
- After 90 days participants will also be asked to repeat a 10 question validated fatigue assessment scale (FAS)
- After 90 days participants will be asked about their menstrual cycle pattern over the 90 day period
Control group:
- All participants will receive standard of care nutrition and exercise advice from a trained registered dietician.
- After 90 days blood work for fasting and 2 hour glucose/insulin, hgba1c, CRP, lipid panel, liver enzymes, SHBG, free and total testosterone, DHEAS, androstenedione, 17-OH-Progesterone, prolactin, TSH, FSH, LH, E2, estrone, Vit D will be obtained.
- After 90 days, participants in the control group will be given the opportunity to receive CGM devices to monitor blood glucose up to 30 days with education on how to use the device and associated phone application to monitor blood glucose.
- After 90 days participants will also be asked to repeat a 10 question validated fatigue assessment scale (FAS)
- After 90 days participants will be asked about their menstrual cycle pattern over the 90 day period
Data Management:
Clinical and laboratory data will be stored in a Research Electronic Data Capture (REDCap) system designed by Dr. Huddleston and research staff. Fields will be designed by study coordinators with input from key investigators. Our team has extensive experience with REDCap architecture and utilization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention arm - CGM | Experimental | Device: DEXCOM Continuous Glucose Monitor (CGM)Participants randomized to intervention arm will be given standard of care nutrition and exercise counseling to optimize weight, nutrition and glycemic status AND will be asked to wear a DEXCOM CGM for 90 days. |
| Control arm | No intervention | –Participants randomized to control arm will ONLY be given standard of care nutrition and exercise counseling to optimize weight, nutrition and glycemic status. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Aged 18-45
- Female sex
- Agree to wear a CGM for 10 days
- Have access to an apple or android smart phone for CGM monitoring
- Are able to be characterized as PCOS or non-PCOS using the 2003 Rotterdam criteria for PCOS of 2 or more of the following: 1) biochemical or clinical hyperandrogenism, 2) polycystic ovarian morphology on transvaginal ultrasound, and/or 3) oligo-amenorrhea
Key exclusion criteria (4 listed)
- Use of metformin or other anti-diabetic agents
- Diagnosis of type I or II diabetes mellitus (including those found to have fasting glucose >126, 2 hour glucose >200, Hgba1c >6.5)
- Prior or current use of CGM
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 |
|---|---|---|
| DEXCOM Continuous Glucose Monitor (CGM)Dexcom CGMs are placed every 10 days and provide a continuous assessment of blood glucose. | Device | Intervention arm - CGM |
Primary outcome
Difference between change in hemoglobin A1C
Time frame: 90 days
Difference between change in hemoglobin A1C for 2 treatment arms from baseline to after 90 days
1 secondary outcome
Difference between change in fasting insulin
Time frame: 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Background: PubMed 35869507Tatulashvili S, Baptiste Julla J, Sritharan N, Rezgani I, Levy V, Bihan H, Riveline JP, Cosson E. Ambulatory Glucose Profile According to Different Phases of the Menstrual Cycle in Women Living With Type 1 Diabetes. J Clin Endocrinol Metab. 2022 Sep 28;107(10):2793-2800. doi: 10.1210/clinem/dgac443.
- Background: PubMed 14752302Legro RS, Castracane VD, Kauffman RP. Detecting insulin resistance in polycystic ovary syndrome: purposes and pitfalls. Obstet Gynecol Surv. 2004 Feb;59(2):141-54. doi: 10.1097/01.OGX.0000109523.25076.E2.
- Background: PubMed 23065822Diamanti-Kandarakis E, Dunaif A. Insulin resistance and the polycystic ovary syndrome revisited: an update on mechanisms and implications. Endocr Rev. 2012 Dec;33(6):981-1030. doi: 10.1210/er.2011-1034. Epub 2012 Oct 12.
- Individual participant dataSharing planned: No
Related trials for PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries
RecruitingPhase 3
Role of Semaglutide in Restoring Ovulation in Youth and Adults With Polycystic Ovary Syndrome
PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries, Obese
Not yet recruitingObservational study
Evaluation of Fibromyalgia Frequency and Pain Parameters in Women With Polycystic Ovary Syndrome
Fibromyalgia, PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries
RecruitingPhase 2
Effects of Adding Quercetin or Alpha Lipoic Acid to Usual Care on Symptoms and Blood Markers in Iraqi Women With Polycystic Ovary Syndrome
PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries
Recruiting
Best Treatment for Women With Both (Polycystic Ovary Syndrome) PCOS and Subclinical Hypothyroidism
PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries, Subclinical Hypothyroidism
Not yet recruitingObservational study
Laboratory and Ultrasound Findings and Response to Letrozole in PCOS Patients
PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries
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.
Heather G Huddleston, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DEXCOM Continuous Glucose Monitor (CGM) in people with PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries and Dysglycemia, run by University of California, San Francisco 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 10 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 14 Jul 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 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?
This study is still under way. Results are not available in the source record yet.
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?
Difference between change in hemoglobin A1C (time frame: 90 days). 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 NCT06050265, which also lists 3 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 14 Jul 2026.