Polycystic Ovarian SyndromePhase 4NCT02027337
Hemocoagulation and Lipoperoxidation in Women Using Combined Oral Contraceptives, Correction by Antioxidants
A Phase 4 study testing 20 mcg ethinylestradiol /3 mg drospirenone, 20 mcg ethinylestradiol/3 mg drospirenone and Selmevit and 30 mcg ethinylestradiol/3 mg drospirenone in people with Polycystic Ovarian Syndrome and Hyperandrogenism, run by Tyumen State Medical University at 1 site in Russia.
Trial summary
We investigate parameters of hemocoagulation and lipoperoxidation in women using combined oral contraceptives with antiandrogenic activity (containing drospirenone with 20 or 30 mcg ethinylestradiol; or cyproterone acetate); correction of these changes by antioxidants Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Polycystic Ovarian Syndrome, Hyperandrogenism, Menstrual Irregularities
- What is being tested?
- 20 mcg ethinylestradiol /3 mg drospirenone, 20 mcg ethinylestradiol/3 mg drospirenone and Selmevit and 30 mcg ethinylestradiol/3 mg drospirenone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteRussia
- Study dates
- Dec 2013to Oct 2015
- Phase
- Phase 4
- 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women aged 18-35 years
- Absence of contraindications for COC use
- Informed voluntary consent for examination
Who cannot join
- Age younger than 18 and older than 35 years
- Refusal or failure to comply with the study protocol
- Drug or alcohol dependence
- Psychiatric diseases
- Severe somatic and allergic diseases
- Pregnancy
Show all 10Show fewer
- Malignancies
- Taking drugs that affect haemostasis, including hormonal contraceptives during 6 months before study beginning
- Cases of thrombosis among first-line relatives in family history
- Contraindications to the COC use under Eligibility Criteria of hormonal contraception (WHO, 2012)
Trial locations and contacts
1 site in 1 country.
Tatyana N Khvoschina contact
Russia1 site, 1 recruiting
- Recruiting
Tyumen State Medical Academy
Tyumen, 3452
Tatyana N Khvoschina, hvoschina-t@yandex.ru
Tatyana N Khvoschina
About this study
Official title: The Changes of Hemocoagulation and Lipoperoxidation in Women Using Combined Oral Contraceptives With Antiandrogenic Activity, Correction by Antioxidants
We investigate parameters of hemocoagulation and lipoperoxidation in women using combined oral contraceptives with antiandrogenic activity (containing drospirenone with 20 or 30 mcg ethinylestradiol; or cyproterone acetate); correction of these changes by antioxidants
Read the detailed description
It is well known that hormonal contraceptives using increase risk of thrombosis. We conduct parameters of hemostasis in women that use combined oral contraceptives with antiandrogenic activity for contraception and treatment. Considering relationship between lipoperoxidation in platelets and hemostasis we expect that limitation of lipoperoxidation by antioxidants can restrict hypercoagulation and decrease risk of thrombosis.
The purpose of this study is decrease of thrombosis risk in women that use combined oral contraceptives containing 20 mcg ethinylestradiol/3 mg drospirenone, 30 mcg ethinylestradiol/3 mg drospirenone, 35 mcg ethinylestradiol/2mg cyproterone acetate. Half of the women of each arm (group) receive only combined oral contraceptives (COC), other women receive combined oral contraceptives and antioxidant complex Selmevit.
The blood tests conduct on 19-21 days of the menstrual cycle before COC use (control group) or on 19-21 days of COC use after 1, 3, 6 and 12 cycles.
Also we investigate subjective tolerability, therapeutic effects, menstrual cycle control and adverse effects of COCs in women that have or have no antioxidant complex Selmevit
- Being tested
- 20 mcg ethinylestradiol /3 mg drospirenone, 20 mcg ethinylestradiol/3 mg drospirenone and Selmevit, 30 mcg ethinylestradiol/3 mg drospirenone, 30 mcg ethinylestradiol/3 mg drospirenone and Selmevit, 35 mcg ethinylestradiol/2 mg cyproterone
- Keywords
- combined oral contraceptives, drospirenone, cyproterone, hemostasis, antioxidants
- Medical subject headings
- Polycystic Ovary Syndrome, Hyperandrogenism, Menstruation Disturbances
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
20 mcg ethinylestradiol /3 mg drospirenoneDrug
Also called Yaz
One contraceptive pill in each day of 28 day cycle. Number of Cycles: 12
20 mcg ethinylestradiol/3 mg drospirenone and SelmevitDrug
Also called Yaz, Selmevit
One contraceptive pill in each day of 28 day cycle. Number of Cycles: 12. Two pills of Selmevit in each day during 30 days, repeat of the course every 3 months.
30 mcg ethinylestradiol/3 mg drospirenoneDrug
Also called Yasmin
One contraceptive pill in each of 21 days, than 7 days break. Number of Cycles: 12
30 mcg ethinylestradiol/3 mg drospirenone and SelmevitDrug
Also called Yasmin, Selmevit
One contraceptive pill in each of 21 days, than 7 days break. Number of Cycles: 12 Two pills of Selmevit in each day during 30 days, repeat of the course every 3 months.
35 mcg ethinylestradiol/2 mg cyproteroneDrug
Also called Diane-35, Chloe
1 contraceptive pill in each day of 28 day cycle. Number of Cycles: 12
35 mcg ethinylestradiol/2 mg cyproterone and SelmevitDrug
Also called Diane-35, Chloe, Selmevit
One contraceptive pill in each day of 28 day cycle. Number of Cycles: 12. Two pills of Selmevit in each day during 30 days, repeat of the course every 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Healthy women that no use combined oral contraceptives |
| 20 mcg EE/3 mg drospirenone | Experimental | Women that use combined oral contraceptives containing 20 mcg ethinylestradiol/3 mg drospirenone (Yaz) Receives: Drug: 20 mcg ethinylestradiol /3 mg drospirenone |
| 20 mcg EE/3 mg drospirenone and Selmevit | Experimental | Women that use combined oral contraceptives containing 20 mcg ethinylestradiol/3 mg drospirenone (Yaz) and antioxidant complex Selmevit Receives: Drug: 20 mcg ethinylestradiol/3 mg drospirenone and Selmevit |
| 30 mcg EE/3 mg drospirenone | Experimental | Women that use combined oral contraceptives containing 30 mcg ethinylestradiol/3 mg drospirenone (Yasmin) Receives: Drug: 30 mcg ethinylestradiol/3 mg drospirenone |
| 30 mcg EE/3 mg drospirenone and Selmevit | Experimental | Women that use combined oral contraceptives containing 30 mcg ethinylestradiol/3 mg drospirenone (Yasmin) and antioxidant complex Selmevit Receives: Drug: 30 mcg ethinylestradiol/3 mg drospirenone and Selmevit |
| 35 mcg EE/2mg cyproterone | Experimental | Women that use combined oral contraceptives containing 35 mcg ethinylestradiol/2 mg cyproterone Receives: Drug: 35 mcg ethinylestradiol/2 mg cyproterone |
| 35 mcg EE/2 mg cyproterone and Selmevit | Experimental | Women that use combined oral contraceptives containing 20 mcg ethinylestradiol/2 mg cyproterone and Selmevit Receives: Drug: 35 mcg ethinylestradiol/2 mg cyproterone and Selmevit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Activated recalcification time
Measured: Baseline, 1, 3, 6 and 12 cycles of 4 weeks (between days 18 and 21 of each cycle)
Change from Baseline in Activated partial thromboplastin time
Measured: Baseline, 1, 3, 6 and 12 cycles of 4 weeks (between days 18 and 21 of each cycle)
Change from Baseline in Prothrombin time
Measured: Baseline, 1, 3, 6 and 12 cycles of 4 weeks (between days 18 and 21 of each cycle)
Change from Baseline in International normalized ratio
Measured: Baseline, 1, 3, 6 and 12 cycles of 4 weeks (between days 18 and 21 of each cycle)
Change from Baseline in D-dimer concentration
Measured: Baseline, 1, 3, 6 and 12 cycles of 4 weeks (between days 18 and 21 of each cycle)
Change from Baseline in Fibrinogen concentration
Measured: Baseline, 1, 3, 6 and 12 cycles of 4 weeks (between days 18 and 21 of each cycle)
Change from Baseline in Soluble fibrin-monomer complexes concentration
Measured: Baseline, 1, 3, 6 and 12 cycles of 4 weeks (between days 18 and 21 of each cycle)
Change from Baseline in Platelet aggregation
Measured: Baseline, 1, 3, 6 and 12 cycles of 4 weeks (between days 18 and 21 of each cycle)
Change from Baseline in Antithrombin III activity
Measured: Baseline, 1, 3, 6 and 12 cycles of 4 weeks (between days 18 and 21 of each cycle)
Change from Baseline in Reserve plasminogen index
Measured: Baseline, 1, 3, 6 and 12 cycles of 4 weeks (between days 18 and 21 of each cycle)
Change from Baseline in Erythrocyte Lipoperoxidation products, extractable in heptane and isopropanol
Measured: Baseline, 1, 3, 6 and 12 cycles of 4 weeks (between days 18 and 21 of each cycle)
Change from Baseline in Malondialdehyde Concentration in Erythrocytes
Measured: Baseline, 1, 3, 6 and 12 cycles of 4 weeks (between days 18 and 21 of each cycle)
Change from Baseline in Glutathion-S-transferase Activity in Erythrocytes
Measured: Baseline, 1, 3, 6 and 12 cycles of 4 weeks (between days 18 and 21 of each cycle)
Change from Baseline in Superoxide dismutase Activity in Erythrocytes
Measured: Baseline, 1, 3, 6 and 12 cycles of 4 weeks (between days 18 and 21 of each cycle)
Vitamin A and E plasma concentration
Measured: Baseline, 1, 3, 6 and 12 cycles of 4 weeks (between days 18 and 21 of each cycle)
Secondary outcomes (2)
Frequency of adverse effects
Measured: 12 cycles of 4 weeks
Subjective tolerability of contraceptives
Measured: 12 cycles of 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2014 (estimated)
- Study startDec 2013
- Primary completionMar 2015 (estimated)
- Study completionOct 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovarian SyndromeStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tyumen State Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Khvoschina Tatyana N., Tyumen State Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02027337
- Sponsor's protocol ID
- 01200707998
- Status last verified
- Jan 2014
- First submitted
- 26 Dec 2013
- Last updated
- 21 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Changes of Hemocoagulation and Lipoperoxidation in Women Using Combined Oral Contraceptives With Antiandrogenic Activity, Correction by Antioxidants
- ClinicalTrials.gov ID
- NCT02027337
- Acronym / sponsor ID
- 01200707998
- Keywords
- combined oral contraceptives, drospirenone, cyproterone, hemostasis, antioxidants
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Tyumen State Medical UniversityUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Mar 2015 (estimated)
- Study completion
- Oct 2015 (estimated)
- First posted
- 6 Jan 2014 (estimated)
- 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.
We investigate parameters of hemocoagulation and lipoperoxidation in women using combined oral contraceptives with antiandrogenic activity (containing drospirenone with 20 or 30 mcg ethinylestradiol; or cyproterone acetate); correction of these changes by antioxidants
Detailed description
It is well known that hormonal contraceptives using increase risk of thrombosis. We conduct parameters of hemostasis in women that use combined oral contraceptives with antiandrogenic activity for contraception and treatment. Considering relationship between lipoperoxidation in platelets and hemostasis we expect that limitation of lipoperoxidation by antioxidants can restrict hypercoagulation and decrease risk of thrombosis.
The purpose of this study is decrease of thrombosis risk in women that use combined oral contraceptives containing 20 mcg ethinylestradiol/3 mg drospirenone, 30 mcg ethinylestradiol/3 mg drospirenone, 35 mcg ethinylestradiol/2mg cyproterone acetate. Half of the women of each arm (group) receive only combined oral contraceptives (COC), other women receive combined oral contraceptives and antioxidant complex Selmevit.
The blood tests conduct on 19-21 days of the menstrual cycle before COC use (control group) or on 19-21 days of COC use after 1, 3, 6 and 12 cycles.
Also we investigate subjective tolerability, therapeutic effects, menstrual cycle control and adverse effects of COCs in women that have or have no antioxidant complex Selmevit
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Healthy women that no use combined oral contraceptives |
| 20 mcg EE/3 mg drospirenone | Experimental | Drug: 20 mcg ethinylestradiol /3 mg drospirenoneWomen that use combined oral contraceptives containing 20 mcg ethinylestradiol/3 mg drospirenone (Yaz) |
| 20 mcg EE/3 mg drospirenone and Selmevit | Experimental | Drug: 20 mcg ethinylestradiol/3 mg drospirenone and SelmevitWomen that use combined oral contraceptives containing 20 mcg ethinylestradiol/3 mg drospirenone (Yaz) and antioxidant complex Selmevit |
| 30 mcg EE/3 mg drospirenone | Experimental | Drug: 30 mcg ethinylestradiol/3 mg drospirenoneWomen that use combined oral contraceptives containing 30 mcg ethinylestradiol/3 mg drospirenone (Yasmin) |
| 30 mcg EE/3 mg drospirenone and Selmevit | Experimental | Drug: 30 mcg ethinylestradiol/3 mg drospirenone and SelmevitWomen that use combined oral contraceptives containing 30 mcg ethinylestradiol/3 mg drospirenone (Yasmin) and antioxidant complex Selmevit |
| 35 mcg EE/2mg cyproterone | Experimental | Drug: 35 mcg ethinylestradiol/2 mg cyproteroneWomen that use combined oral contraceptives containing 35 mcg ethinylestradiol/2 mg cyproterone |
| 35 mcg EE/2 mg cyproterone and Selmevit | Experimental | Drug: 35 mcg ethinylestradiol/2 mg cyproterone and SelmevitWomen that use combined oral contraceptives containing 20 mcg ethinylestradiol/2 mg cyproterone and Selmevit |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Women aged 18-35 years
- Absence of contraindications for COC use
- Informed voluntary consent for examination
Key exclusion criteria (10 listed)
- Age younger than 18 and older than 35 years
- Refusal or failure to comply with the study protocol
- Drug or alcohol dependence
- Psychiatric diseases
- Severe somatic and allergic diseases
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 |
|---|---|---|
| 20 mcg ethinylestradiol /3 mg drospirenoneAlso: YazOne contraceptive pill in each day of 28 day cycle. Number of Cycles: 12 | Drug | 20 mcg EE/3 mg drospirenone |
| 20 mcg ethinylestradiol/3 mg drospirenone and SelmevitAlso: Yaz, SelmevitOne contraceptive pill in each day of 28 day cycle. Number of Cycles: 12. Two pills of Selmevit in each day during 30 days, repeat of the course every 3 months. | Drug | 20 mcg EE/3 mg drospirenone and Selmevit |
| 30 mcg ethinylestradiol/3 mg drospirenoneAlso: YasminOne contraceptive pill in each of 21 days, than 7 days break. Number of Cycles: 12 | Drug | 30 mcg EE/3 mg drospirenone |
| 30 mcg ethinylestradiol/3 mg drospirenone and SelmevitAlso: Yasmin, SelmevitOne contraceptive pill in each of 21 days, than 7 days break. Number of Cycles: 12 Two pills of Selmevit in each day during 30 days, repeat of the course every 3 months. | Drug | 30 mcg EE/3 mg drospirenone and Selmevit |
| 35 mcg ethinylestradiol/2 mg cyproteroneAlso: Diane-35, Chloe1 contraceptive pill in each day of 28 day cycle. Number of Cycles: 12 | Drug | 35 mcg EE/2mg cyproterone |
| 35 mcg ethinylestradiol/2 mg cyproterone and SelmevitAlso: Diane-35, Chloe, SelmevitOne contraceptive pill in each day of 28 day cycle. Number of Cycles: 12. Two pills of Selmevit in each day during 30 days, repeat of the course every 3 months. | Drug | 35 mcg EE/2 mg cyproterone and Selmevit |
Primary outcome
Change from Baseline in Activated recalcification time
Time frame: Baseline, 1, 3, 6 and 12 cycles of 4 weeks (between days 18 and 21 of each cycle)
Change from Baseline in Activated partial thromboplastin time
Time frame: Baseline, 1, 3, 6 and 12 cycles of 4 weeks (between days 18 and 21 of each cycle)
Change from Baseline in Prothrombin time
Time frame: Baseline, 1, 3, 6 and 12 cycles of 4 weeks (between days 18 and 21 of each cycle)
Change from Baseline in International normalized ratio
Time frame: Baseline, 1, 3, 6 and 12 cycles of 4 weeks (between days 18 and 21 of each cycle)
Change from Baseline in D-dimer concentration
Time frame: Baseline, 1, 3, 6 and 12 cycles of 4 weeks (between days 18 and 21 of each cycle)
Change from Baseline in Fibrinogen concentration
Time frame: Baseline, 1, 3, 6 and 12 cycles of 4 weeks (between days 18 and 21 of each cycle)
Change from Baseline in Soluble fibrin-monomer complexes concentration
Time frame: Baseline, 1, 3, 6 and 12 cycles of 4 weeks (between days 18 and 21 of each cycle)
Change from Baseline in Platelet aggregation
Time frame: Baseline, 1, 3, 6 and 12 cycles of 4 weeks (between days 18 and 21 of each cycle)
Change from Baseline in Antithrombin III activity
Time frame: Baseline, 1, 3, 6 and 12 cycles of 4 weeks (between days 18 and 21 of each cycle)
Change from Baseline in Reserve plasminogen index
Time frame: Baseline, 1, 3, 6 and 12 cycles of 4 weeks (between days 18 and 21 of each cycle)
Change from Baseline in Erythrocyte Lipoperoxidation products, extractable in heptane and isopropanol
Time frame: Baseline, 1, 3, 6 and 12 cycles of 4 weeks (between days 18 and 21 of each cycle)
Change from Baseline in Malondialdehyde Concentration in Erythrocytes
Time frame: Baseline, 1, 3, 6 and 12 cycles of 4 weeks (between days 18 and 21 of each cycle)
Change from Baseline in Glutathion-S-transferase Activity in Erythrocytes
Time frame: Baseline, 1, 3, 6 and 12 cycles of 4 weeks (between days 18 and 21 of each cycle)
Change from Baseline in Superoxide dismutase Activity in Erythrocytes
Time frame: Baseline, 1, 3, 6 and 12 cycles of 4 weeks (between days 18 and 21 of each cycle)
Vitamin A and E plasma concentration
Time frame: Baseline, 1, 3, 6 and 12 cycles of 4 weeks (between days 18 and 21 of each cycle)
2 secondary outcomes
Frequency of adverse effects
Time frame: 12 cycles of 4 weeks
Subjective tolerability of contraceptives
Time frame: 12 cycles of 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2014.
Related trials for Polycystic Ovarian Syndrome
Recruiting
The Effects of the Mediterranean Diet and Synbiotics in Polycystic Ovary Syndrome
PCOS (Polycystic Ovary Syndrome)
Recruiting
Brown Adipose Tissue Modulation in Polycystic Ovary Syndrome Using Infrared Thermography
Polycystic Ovary Syndrome (PCOS)
Active, not recruiting
Mindfulness-Based Education For Women With Polycystic Ovary Syndrome
Polycystic Ovary Syndrome (PCOS), Menstrual Symptoms
Not yet recruitingObservational study
Chinese Overweight/Obesity Cohort: Metabolic & Comorbidity Risks
Obesity & Overweight, Diabetes Mellitus, Type 2
RecruitingPhase 1
Safety of Cultured Allogeneic Adult Umbilical Cord or Placental Derived Mesenchymal Stem Cells for PCOS
Polycystic Ovary Syndrome (PCOS), Polycystic Ovary Syndrome
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.
Tatyana N Khvoschina contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 20 mcg ethinylestradiol /3 mg drospirenone, 20 mcg ethinylestradiol/3 mg drospirenone and Selmevit and 30 mcg ethinylestradiol/3 mg drospirenone in people with Polycystic Ovarian Syndrome and Hyperandrogenism, run by Tyumen State Medical University at 1 site in Russia.
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 10 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: status not confirmed, as of the sponsor's last update on 21 Nov 2014. 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 Russia. 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tatyana N Khvoschina (hvoschina-t@yandex.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Activated recalcification time (time frame: Baseline, 1, 3, 6 and 12 cycles of 4 weeks (between days 18 and 21 of each cycle)). The study lists 15 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 21 Nov 2014.