Perimenopausal DisorderPhase 4ChangesNCT03003949
The Menopause Transition: Estrogen Variability, Stress Reactivity and Mood
A Phase 4 study testing Estradiol Patch, 0.1 Mg/24 Hours Weekly Transdermal Film, Extended Release and Progesterone Capsule in people with Perimenopausal Disorder and Stress, Emotional, run by University of North Carolina, Chapel Hill at 2 sites in United States.
Trial summary
Women in the menopause transition ('perimenopause') are exposed to extreme hormone variability, tend to experience a unique set of severe stressors (e.g., divorce, death of loved ones), and are also at substantially elevated risk to suffer from mood and anxiety disorders. Read more about this study
- Who is it for?
- Ages 45 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Perimenopausal Disorder, Stress, Emotional
- What is being tested?
- Estradiol Patch, 0.1 Mg/24 Hours Weekly Transdermal Film, Extended Release and Progesterone Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 82 participants
- Where
- 2 sitesUnited States
- Study dates
- 24 Jan 2017to 10 May 2020
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 45 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Perimenopausal (either early perimenopause, defined as menstrual cycle length 7+ days longer or shorter than usual; or the late perimenopause, defined as ≥2 skipped cycles and an interval of amenorrhea ≥60 days but within one year of the last menstrual period)
- 45 to 60 years of age
- must be medically healthy
Who cannot join
- a history of cardiovascular disease (CVD) including coronary artery disease, arteriosclerosis, heart attack, or stroke
- Type I or II diabetes
- personal history of thrombotic events
- personal or family history suggesting elevated risk for E2-related cancer
- currently experiencing migraine headaches with aura
Trial locations and contacts
2 sites in 1 country.
United States2 sites
UNC SHARRP Lab
Chapel Hill, North Carolina, 27517
Susan Girdler, PhD, Principal Investigator
Chapel Hill, North Carolina, 27599
About this study
Official title: The Menopause Transition: Estrogen Variability, HPA Axis and Affective Symptoms
Women in the menopause transition ('perimenopause') are exposed to extreme hormone variability, tend to experience a unique set of severe stressors (e.g., divorce, death of loved ones), and are also at substantially elevated risk to suffer from mood and anxiety disorders. The purpose of this research is to understand the mechanisms by which variability in estradiol (E2) is associated with the symptoms of anxiety and anhedonia (loss of interest and pleasure - a common symptom of depression). By stabilizing E2 variability with a hormonal manipulation, this research will determine the degree to which the E2 variability (or E2 levels) plays a causal role in perimenopausal anxiety and anhedonia symptoms and whether it does so by affecting biological responses to stress.
Read the detailed description
Framed within a diathesis-stress model, the primary objective of this research is to determine the pathophysiological mechanisms of estradiol (E2) in the clinical anxiety and anhedonia seen in the menopause transition (MT). Specifically whether E2 variability or E2 levels predict exaggerated hypothalamic-pituitary-adrenal (HPA) axis reactivity and impaired recovery to stress and, in turn, deficits in behavioral indices of threat responsivity and approach motivation and symptoms of anxiety and anhedonia. The secondary objective of the research is to use a hormonal manipulation as a mechanistic probe to stabilize E2 variability in premenopausal ranges and determine if: a) HPA axis reactivity/recovery represents a biomarker of behavioral and symptom responses to E2 stabilization; b) whether recent severe life stress predicts the HPA axis response to hormone stabilization.
A total of 170 women in the early or late MT who are eligible for the hormonal probe will be recruited to reflect the full continuum of anxiety and anhedonia symptoms based on self-report to the State-Trait Anxiety Inventory and the Snaith-Hamilton Pleasure Scale, respectively. However, the investigators will over-represent the clinically impairing end of the anxious and anhedonic phenotype (75% of the sample). Over an 8-week baseline, anxiety and anhedonia symptoms and serum E2 measured by liquid chromatography-tandem mass spectrometry (LC-MS/MS) will be assessed on a weekly basis. At baseline week 8, HPA axis (plasma cortisol and ACTH) response to the Trier Social Stress Test and behavioral measures of threat responsivity (via Dot-Probe task) and approach motivation (Effort Expenditure for Rewards Task 'EEfRT') will be determined. Using transdermal E2 as a pharmacological probe to stabilize variability of E2 in premenopausal ranges, women will then be randomized to transdermal E2 (0.10 mg) or placebo for 16 weeks. This is not a clinical efficacy trial. The investigators will use an randomized control trial (RCT) design with a hormonal manipulation in order to investigate the pathophysiologic role of E2 variability (or E2 levels) in HPA axis dysregulation and, in turn, threat responsivity and approach motivation. Serum E2 will be assessed weekly during weeks 9-16, and HPA axis reactivity to stress and behavioral responses to the Dot-Probe and EEfRT tasks will be assessed every four weeks during the 16 week probe.
- Conditions
- Perimenopausal Disorder, Stress, Emotional
- Being tested
- Estradiol Patch, 0.1 Mg/24 Hours Weekly Transdermal Film, Extended Release, Placebo Patch, Progesterone Capsule, Placebo Oral Capsule
- Keywords
- perimenopause, menopause transition, estrogen, stress, mood
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Estradiol Patch, 0.1 Mg/24 Hours Weekly Transdermal Film, Extended ReleaseDrug
Also called Climara, Prometrium
Transdermal Estradiol worn daily for 16 weeks (patch changed every 7 days).
Placebo PatchDrug
Also called Placebos
Matching placebo patches to be worn every day for 16 weeks (patch changed every 7 days).
Progesterone CapsuleDrug
Also called Progesterone
Micronized progesterone (200 mg) will be administered every day for 12 days during the 9th week of randomization and again following randomization at the 17th week
Placebo Oral CapsuleDrug
Also called Placebos
Matching placebo capsules will be administered orally every day for 12 days during the 9th week of randomization and again following randomization at the 17th week.
| Study group | Role | What they receive |
|---|---|---|
| Placebo Patch and Placebo Capsule | Placebo comparator | Placebo patches worn for 16 weeks. On the 9th week of patch, oral placebo capsule taken daily for 12 days. Following the 16 weeks of patch use oral placebo capsule taken daily for 12 days. Receives: Drug: Placebo Patch; Drug: Placebo Oral Capsule |
| Estradiol patch and progesterone capsule | Active comparator | Estradiol patches worn for 16 weeks. On the 9th week of patch, oral progesterone capsule taken daily for 12 days. Following the 16 weeks of estradiol patch use oral progesterone capsule taken daily for 12 days. Receives: Drug: Estradiol Patch, 0.1 Mg/24 Hours Weekly Transdermal Film, Extended Release; Drug: Progesterone Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change Over Time in the Anxiety Score From State-Trait Anxiety Inventory
The State-Trait anxiety inventory is consists of 20 questions on a 4-point force-choice Likert-type response scales (scores 0 - 3). The 20 questions are summed together for final score. The score can range from 0 to 60 with higher scores representing higher levels of anxiety. Change over time is defined as the difference in the least square means between timepoints and 95% confidence interval limits.
Measured: Baseline (Week 8), Weeks 16, 20 and 24
Change Over Time in Anhedonia Score From Snaith-Hamilton Pleasure Scale
Anhedonia will be assessed using SHAPS scores which range from 14-56, with higher scores corresponding to higher levels of anhedonia. Change over time is defined as the difference in least square means between time points and 95% confidence interval limits.
Measured: Baseline (Week 8), Weeks 16, 20 and 24
Secondary outcomes (3)
Change Over Time in AUC Cortisol Stress Response
The stress biomarker cortisol (µg/dL) assessed at rest and in response to the Trier Social Stress test (AUC with respect to ground) at baseline (Week 8) and again post-randomization at weeks 16, 20 and 24. Blood serum samples for measuring cortisol are taken at immediately before the Trier Social Stress test and at 10, 20, 30, and 45 minutes post test. Change over time is defined as the difference in least square means between timepoints and with 95% confidence interval limits.
Measured: Baseline (Week 8), Weeks 16, 20 and 24
Change Over Time in Threat Bias Score From Dot Probe Task
Changes in threat bias scores assessed using Dot Probe task during labs at weeks 8, 16, 20 and 24. The bias measurement protocol consists of 144 trials (48 threat congruent, 48 threat incongruent, 48 neutral presentations). Participants indicate the probe letter via button press. Angry face location, probe location, probe type and actor are all fully counterbalanced in presentation. The threat bias score equals the mean of reaction time on threat congruent from threat incongruent trials. A threat bias scores >0 indicate a bias towards threat, whereas scores <0 mean that the participant is slower to respond to threatening stimuli than neutral stimuli. Reaction times were measured in milliseconds. Change over time is defined as the difference in least square means between timepoints with 95% confidence interval limits.
Measured: up to 24 weeks
Change Over Time in Percent of "Hard Task" Choice in EEfRT
Effort Expenditure for Rewards Task (EEfRT) measures approach motivation that indexes the willingness to expend effort to obtain monetary rewards under varying conditions of reward probability and magnitude. On each trial, participants choose between an "easy task" and a "hard task" and are presented with information about the probability of winning (i.e., 12%, 50%, or 88%), and the magnitude of the potential reward if they complete the button-press task successfully (range: $1.24 - $4.12). Completion of the easy task requires 30 button presses in 7 seconds using the dominant index finger, whereas completion of the hard task requires 100 presses with the non-dominant "pinky" finger in 21 seconds. The percent of hard task choices is the dependent measure. Change over time is defined as the difference in least square means between time points with 95% confidence interval limits.
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2016 (estimated)
- Study start24 Jan 2017
- Primary completion10 May 2020
- Study completion10 May 2020
Why it stopped: In-person visit restrictions due to COVID-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Perimenopausal 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Susan Girdler, PhD, Principal investigator, Research Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03003949
- Sponsor's protocol ID
- 16-1731
- Other IDs
- 1R01MH108690-01A1
- Acronym
- Changes
- Status last verified
- Mar 2020
- First submitted
- 6 Dec 2016
- Last updated
- 26 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The investigators will submit data to the Research Domain Criteria Database (RDoCdb) and/or the National Database for Clinical Trials Related to Mental Illness (NDCT). The investigators will work with RDoCdb and NDCT staff to define data structures for any data being collected as part of the study. Descriptive data will be submitted two times per year and provide supporting documentation as necessary for others to more fully understand the manner in which data were collected. The investigators will submit cumulative data each submission cycle and will review data for any personally identifiable information and ensure that data are loaded correctly. The investigators will share data within 4 months after submission and submit experimental data within 12 months after study completion. Study data for each publication will be created and submit a link to the RDoCdb study along with any publications so readers of articles can link back to the data used in RDoCdb and NDCT.
Publications
Lozza-Fiacco S, Gordon JL, Andersen EH, Kozik RG, Neely O, Schiller C, Munoz M, Rubinow DR, Girdler SS. Baseline anxiety-sensitivity to estradiol fluctuations predicts anxiety symptom response to transdermal estradiol treatment in perimenopausal women - A randomized clinical trial. Psychoneuroendocrinology. 2022 Sep;143:105851. doi: 10.1016/j.psyneuen.2022.105851. Epub 2022 Jul 2.
PubMed 35809362
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Menopause Transition: Estrogen Variability, HPA Axis and Affective Symptoms
- ClinicalTrials.gov ID
- NCT03003949
- Acronym / sponsor ID
- Changes / 16-1731
- Conditions
- Perimenopausal Disorder, Stress, Emotional
- Keywords
- perimenopause, menopause transition, estrogen, stress, mood
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: In-person visit restrictions due to COVID-19
- Enrolment
- 82 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 24 Jan 2017 (actual)
- Primary completion
- 10 May 2020 (actual)
- Study completion
- 10 May 2020 (actual)
- First posted
- 28 Dec 2016 (estimated)
- Results
- Posted 26 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Women in the menopause transition ('perimenopause') are exposed to extreme hormone variability, tend to experience a unique set of severe stressors (e.g., divorce, death of loved ones), and are also at substantially elevated risk to suffer from mood and anxiety disorders. The purpose of this research is to understand the mechanisms by which variability in estradiol (E2) is associated with the symptoms of anxiety and anhedonia (loss of interest and pleasure - a common symptom of depression). By stabilizing E2 variability with a hormonal manipulation, this research will determine the degree to which the E2 variability (or E2 levels) plays a causal role in perimenopausal anxiety and anhedonia symptoms and whether it does so by affecting biological responses to stress.
Detailed description
Framed within a diathesis-stress model, the primary objective of this research is to determine the pathophysiological mechanisms of estradiol (E2) in the clinical anxiety and anhedonia seen in the menopause transition (MT). Specifically whether E2 variability or E2 levels predict exaggerated hypothalamic-pituitary-adrenal (HPA) axis reactivity and impaired recovery to stress and, in turn, deficits in behavioral indices of threat responsivity and approach motivation and symptoms of anxiety and anhedonia. The secondary objective of the research is to use a hormonal manipulation as a mechanistic probe to stabilize E2 variability in premenopausal ranges and determine if: a) HPA axis reactivity/recovery represents a biomarker of behavioral and symptom responses to E2 stabilization; b) whether recent severe life stress predicts the HPA axis response to hormone stabilization.
A total of 170 women in the early or late MT who are eligible for the hormonal probe will be recruited to reflect the full continuum of anxiety and anhedonia symptoms based on self-report to the State-Trait Anxiety Inventory and the Snaith-Hamilton Pleasure Scale, respectively. However, the investigators will over-represent the clinically impairing end of the anxious and anhedonic phenotype (75% of the sample). Over an 8-week baseline, anxiety and anhedonia symptoms and serum E2 measured by liquid chromatography-tandem mass spectrometry (LC-MS/MS) will be assessed on a weekly basis. At baseline week 8, HPA axis (plasma cortisol and ACTH) response to the Trier Social Stress Test and behavioral measures of threat responsivity (via Dot-Probe task) and approach motivation (Effort Expenditure for Rewards Task 'EEfRT') will be determined. Using transdermal E2 as a pharmacological probe to stabilize variability of E2 in premenopausal ranges, women will then be randomized to transdermal E2 (0.10 mg) or placebo for 16 weeks. This is not a clinical efficacy trial. The investigators will use an randomized control trial (RCT) design with a hormonal manipulation in order to investigate the pathophysiologic role of E2 variability (or E2 levels) in HPA axis dysregulation and, in turn, threat responsivity and approach motivation. Serum E2 will be assessed weekly during weeks 9-16, and HPA axis reactivity to stress and behavioral responses to the Dot-Probe and EEfRT tasks will be assessed every four weeks during the 16 week probe.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo Patch and Placebo Capsule | Placebo comparator | Drug: Placebo Patch, Drug: Placebo Oral CapsulePlacebo patches worn for 16 weeks. On the 9th week of patch, oral placebo capsule taken daily for 12 days. Following the 16 weeks of patch use oral placebo capsule taken daily for 12 days. |
| Estradiol patch and progesterone capsule | Active comparator | Drug: Estradiol Patch, 0.1 Mg/24 Hours Weekly Transdermal Film, Extended Release, Drug: Progesterone CapsuleEstradiol patches worn for 16 weeks. On the 9th week of patch, oral progesterone capsule taken daily for 12 days. Following the 16 weeks of estradiol patch use oral progesterone capsule taken daily for 12 days. |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Perimenopausal (either early perimenopause, defined as menstrual cycle length 7+ days longer or shorter than usual; or the late perimenopause, defined as ≥2 skipped cycles and an interval of amenorrhea ≥60 days but within one year of the last menstrual period)
- 45 to 60 years of age
- must be medically healthy
Key exclusion criteria (5 listed)
- a history of cardiovascular disease (CVD) including coronary artery disease, arteriosclerosis, heart attack, or stroke
- Type I or II diabetes
- personal history of thrombotic events
- personal or family history suggesting elevated risk for E2-related cancer
- currently experiencing migraine headaches with aura
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 |
|---|---|---|
| Estradiol Patch, 0.1 Mg/24 Hours Weekly Transdermal Film, Extended ReleaseAlso: Climara, PrometriumTransdermal Estradiol worn daily for 16 weeks (patch changed every 7 days). | Drug | Estradiol patch and progesterone capsule |
| Placebo PatchAlso: PlacebosMatching placebo patches to be worn every day for 16 weeks (patch changed every 7 days). | Drug | Placebo Patch and Placebo Capsule |
| Progesterone CapsuleAlso: ProgesteroneMicronized progesterone (200 mg) will be administered every day for 12 days during the 9th week of randomization and again following randomization at the 17th week | Drug | Estradiol patch and progesterone capsule |
| Placebo Oral CapsuleAlso: PlacebosMatching placebo capsules will be administered orally every day for 12 days during the 9th week of randomization and again following randomization at the 17th week. | Drug | Placebo Patch and Placebo Capsule |
Primary outcome
Change Over Time in the Anxiety Score From State-Trait Anxiety Inventory
Time frame: Baseline (Week 8), Weeks 16, 20 and 24
The State-Trait anxiety inventory is consists of 20 questions on a 4-point force-choice Likert-type response scales (scores 0 - 3). The 20 questions are summed together for final score. The score can range from 0 to 60 with higher scores representing higher levels of anxiety. Change over time is defined as the difference in the least square means between timepoints and 95% confidence interval limits.
Change Over Time in Anhedonia Score From Snaith-Hamilton Pleasure Scale
Time frame: Baseline (Week 8), Weeks 16, 20 and 24
Anhedonia will be assessed using SHAPS scores which range from 14-56, with higher scores corresponding to higher levels of anhedonia. Change over time is defined as the difference in least square means between time points and 95% confidence interval limits.
3 secondary outcomes
Change Over Time in AUC Cortisol Stress Response
Time frame: Baseline (Week 8), Weeks 16, 20 and 24
Change Over Time in Threat Bias Score From Dot Probe Task
Time frame: up to 24 weeks
Change Over Time in Percent of "Hard Task" Choice in EEfRT
Time frame: up to 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35809362Lozza-Fiacco S, Gordon JL, Andersen EH, Kozik RG, Neely O, Schiller C, Munoz M, Rubinow DR, Girdler SS. Baseline anxiety-sensitivity to estradiol fluctuations predicts anxiety symptom response to transdermal estradiol treatment in perimenopausal women - A randomized clinical trial. Psychoneuroendocrinology. 2022 Sep;143:105851. doi: 10.1016/j.psyneuen.2022.105851. Epub 2022 Jul 2.
- Individual participant dataSharing planned: Yes. The investigators will submit data to the Research Domain Criteria Database (RDoCdb) and/or the National Database for Clinical Trials Related to Mental Illness (NDCT). The investigators will work with RDoCdb and NDCT staff to define data structures for any data being collected as part of the study. Descriptive data will be submitted two times per year and provide supporting documentation as necessary for others to more fully understand the manner in which data were collected. The investigators will submit cumulative data each submission cycle and will review data for any personally identifiable information and ensure that data are loaded correctly. The investigators will share data within 4 months after submission and submit experimental data within 12 months after study completion. Study data for each publication will be created and submit a link to the RDoCdb study along with any publications so readers of articles can link back to the data used in RDoCdb and NDCT.
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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.
Susan Girdler, PhD principal investigator
Research Professor
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Estradiol Patch, 0.1 Mg/24 Hours Weekly Transdermal Film, Extended Release and Progesterone Capsule in people with Perimenopausal Disorder and Stress, Emotional, run by University of North Carolina, Chapel Hill at 2 sites 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 3 inclusion and 5 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: stopped early, as of the sponsor's last update on 26 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change Over Time in the Anxiety Score From State-Trait Anxiety Inventory (time frame: Baseline (Week 8), Weeks 16, 20 and 24). The study lists 2 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 NCT03003949, which also lists 1 linked publication.
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 26 Mar 2021.