Vulvovaginal AtrophyPhase 2NCT03281655
Visnadine, Prenylflavonoids and Bovine Colostrum to Treat Vulvovaginal Atrophy in Postmenopausal Women
A Phase 2 study testing Visnadine, prenylflavonoids and bovine colostrum in people with Vulvovaginal Atrophy and Menopause, run by University of Messina.
Trial summary
The effects of a new vaginal cream containing visnadine (0.30%), prenylflavonoids (0.10%) and bovine colostrum (1%) will be evaluated in post-menopausal sexually active women affected by vulvovaginal atrophy (VVA). In a prospective cohort study, post-menopausal women affected by VVA will be enrolled. Read more about this study
- Who is it for?
- Ages 45 to 70 years, women only
- Conditions the study is for
- Vulvovaginal Atrophy, Menopause
- What is being tested?
- Visnadine, prenylflavonoids and bovine colostrum
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- No sites listed yet
- Study dates
- Dec 2016to Jan 2018
- Phase
- Phase 2
- 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 45 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- postmenopausal sexually active women affected by vulvovaginal atrophy.
Who cannot join
- relevant comorbidities (chronic cardiovascular, immune, endocrine and metabolic diseases and cancers);
- smokers;
- who used any other kind of pharmacologic treatment (including the substances tested in this study) in the previous 3 months.
About this study
Official title: Effects of a New Vaginal Cream Containing Visnadine, Prenylflavonoids and Bovine Colostrum in Postmenopausal Sexually Active Women Affected by Vulvovaginal Atrophy: a Prospective Cohort Analysis
The effects of a new vaginal cream containing visnadine (0.30%), prenylflavonoids (0.10%) and bovine colostrum (1%) will be evaluated in post-menopausal sexually active women affected by vulvovaginal atrophy (VVA).
In a prospective cohort study, post-menopausal women affected by VVA will be enrolled. All women will undergo vaginal health index score (VHIS) evaluation and will complete the female sexual function index (FSFI) questionnaire at baseline evaluation (T0) and following 15 days of vaginal cream treatment with one application per day (T1). All the side effects will be recorded and an independent data safety and monitoring committee will evaluate the results of the study.
Read the detailed description
Sexual health plays a key role during women's lives from puberty to post-menopausal period and, for this reason, it has increasingly received public health, pharmaceutical, and medical attention. According to the study of women's health across the nation (SWAN), more than 75% of the middle-aged women reported that sex was moderately to extremely important; in addition, the menopausal transition was characterized by increasing pain during sexual intercourse and consequent decrease of sexual desire. Individual general health status, diabetes mellitus, cardiovascular diseases, other genitourinary diseases, psychiatric/psychological disorders, other chronic diseases and socio-demographic conditions may all influence post-menopausal sexual health. Although aging could be considered an independent risk factor for sexual dysfunction accumulating evidence suggests that vulvovaginal atrophy (VVA) is strongly associated with female sexual dysfunction (FSD) among sexually active postmenopausal women: in particular, VVA was found to be significantly associated with a global indication of FSD and difficulties with sexual desire, arousal, and orgasm. VVA often results from postmenopausal estrogen loss, which acts as a double-edged sword: on the one hand, it plays a detrimental action on woman's desire and arousal; on the other hand, it decreases the lubrication of the vagina before sexual activity and, consequently, causes pain during intercourse, precludes satisfaction and further decreases arousal.
Although several pharmacological approaches have been evaluated for the relief of VVA. Local estrogens are considered a safe option for VVA, although many clinicians are hesitant to prescribe them and many women reluctant to use them. In addition, non-hormonal treatments such as moisturizers and precoital vaginal lubricants could be considered a safer alternative, even in cancer patients. In this regard, visnadine, an active ingredient of the fruit of Ammi visnaga, showed powerful vasodilatory activity, due to the inhibitory effects on vascular smooth muscles mediated by Ca2+ entry through voltage-gated L-type Ca2+ channels. In addition, visnadine improves both female sexual function index (FSFI) and color Doppler sonography of clitoral blood flow. Furthermore, prenylflavonoids and phytoestrogens play a potent role as estrogen receptor (ER)-alpha selective agonist, thus they may counteract the effects of postmenopausal estrogen loss. Finally, a vaginal cream containing bovine colostrum has been shown to be effective in relieving vaginal dryness and other VVA symptoms in postmenopausal women, after 8 weeks of treatment. Based on this information, the investigators aim to evaluate the effects of a new vaginal cream containing visnadine, prenylflavonoids and bovine colostrum on vaginal health index score (VHIS) and FSFI in a cohort of postmenopausal sexually active women affected by VVA.
- Conditions
- Vulvovaginal Atrophy, Menopause
- Being tested
- Visnadine, prenylflavonoids and bovine colostrum
- Keywords
- Visnadine, Prenylflavonoids, Bovine colostrum, Sexual wellbeing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visnadine, prenylflavonoids and bovine colostrumDrug
15 days, 1 application per day, with a vaginal cream containing visnadine, prenylflavonoids and bovine colostrum.
| Study group | Role | What they receive |
|---|---|---|
| Vulvovaginal atrophy | Experimental | Postmenopausal sexually active women affected by vulvovaginal atrophy undergoing treatment (15 days, 1 application per day) with a vaginal cream containing visnadine, prenylflavonoids and bovine colostrum. Receives: Drug: Visnadine, prenylflavonoids and bovine colostrum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaginal health index score (VHIS) evaluation
Elasticity, fluid volume and consistency, pH, epithelial integrity and moisture.
Measured: Post-treatment (15 days)
Female sexual function index (FSFI) questionnaire
Desire, arousal, lubrication, orgasm, satisfaction and pain.
Measured: Post-treatment (15 days)
Secondary outcomes (1)
Side effects
Number of side effects during/after the treatment.
Measured: Post-treatment (15 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2017
- Study startDec 2016
- Primary completionMay 2017
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Vulvovaginal AtrophyStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single cohort study
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Messina
- Sponsor type
- University, hospital or other
- Collaborators
- University of Victoria, University of Athens
- Responsible party
- Principal investigator, Antonio Simone Laganà, University of Messina
- Investigators
- Antonio Simone Laganà, M.D., Principal investigator, University of MessinaSalvatore Giovanni Vitale, M.D., Principal investigator, University of Messina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03281655
- Sponsor's protocol ID
- REFEEL-1
- Status last verified
- Mar 2020
- First submitted
- 8 Sep 2017
- Last updated
- 25 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Slater C, Robinson AJ. Sexual health in adolescents. Clin Dermatol. 2014 Mar-Apr;32(2):189-95. doi: 10.1016/j.clindermatol.2013.08.002.
PubMed 24559553Schwenkhagen A. Hormonal changes in menopause and implications on sexual health. J Sex Med. 2007 Mar;4 Suppl 3:220-6. doi: 10.1111/j.1743-6109.2007.00448.x.
PubMed 17394594McCabe MP, Sharlip ID, Lewis R, Atalla E, Balon R, Fisher AD, Laumann E, Lee SW, Segraves RT. Incidence and Prevalence of Sexual Dysfunction in Women and Men: A Consensus Statement from the Fourth International Consultation on Sexual Medicine 2015. J Sex Med. 2016 Feb;13(2):144-52. doi: 10.1016/j.jsxm.2015.12.034.
PubMed 26953829Avis NE, Brockwell S, Randolph JF Jr, Shen S, Cain VS, Ory M, Greendale GA. Longitudinal changes in sexual functioning as women transition through menopause: results from the Study of Women's Health Across the Nation. Menopause. 2009 May-Jun;16(3):442-52. doi: 10.1097/gme.0b013e3181948dd0.
PubMed 19212271Avis NE, Colvin A, Bromberger JT, Hess R, Matthews KA, Ory M, Schocken M. Change in health-related quality of life over the menopausal transition in a multiethnic cohort of middle-aged women: Study of Women's Health Across the Nation. Menopause. 2009 Sep-Oct;16(5):860-9. doi: 10.1097/gme.0b013e3181a3cdaf.
PubMed 19436224Dennerstein L, Hayes RD. Confronting the challenges: epidemiological study of female sexual dysfunction and the menopause. J Sex Med. 2005 Sep;2 Suppl 3:118-32. doi: 10.1111/j.1743-6109.2005.00128.x.
PubMed 16422789Hayes R, Dennerstein L. The impact of aging on sexual function and sexual dysfunction in women: a review of population-based studies. J Sex Med. 2005 May;2(3):317-30. doi: 10.1111/j.1743-6109.2005.20356.x.
PubMed 16422862Levine KB, Williams RE, Hartmann KE. Vulvovaginal atrophy is strongly associated with female sexual dysfunction among sexually active postmenopausal women. Menopause. 2008 Jul-Aug;15(4 Pt 1):661-6. doi: 10.1097/gme.0b013e31815a5168.
PubMed 18698279Nappi RE, Palacios S, Particco M, Panay N. The REVIVE (REal Women's VIews of Treatment Options for Menopausal Vaginal ChangEs) survey in Europe: Country-specific comparisons of postmenopausal women's perceptions, experiences and needs. Maturitas. 2016 Sep;91:81-90. doi: 10.1016/j.maturitas.2016.06.010. Epub 2016 Jun 15.
PubMed 27451325Castelo-Branco C, Biglia N, Nappi RE, Schwenkhagen A, Palacios S. Characteristics of post-menopausal women with genitourinary syndrome of menopause: Implications for vulvovaginal atrophy diagnosis and treatment selection. Maturitas. 2015 Aug;81(4):462-9. doi: 10.1016/j.maturitas.2015.05.007. Epub 2015 May 30.
PubMed 26071816Lethaby A, Ayeleke RO, Roberts H. Local oestrogen for vaginal atrophy in postmenopausal women. Cochrane Database Syst Rev. 2016 Aug 31;2016(8):CD001500. doi: 10.1002/14651858.CD001500.pub3.
PubMed 27577677Derzko C, Elliott S, Lam W. Management of sexual dysfunction in postmenopausal breast cancer patients taking adjuvant aromatase inhibitor therapy. Curr Oncol. 2007 Dec;14 Suppl 1(Suppl 1):S20-40. doi: 10.3747/co.2007.151.
PubMed 18087605Bassino E, Antoniotti S, Gasparri F, Munaron L. Effects of flavonoid derivatives on human microvascular endothelial cells. Nat Prod Res. 2016 Dec;30(24):2831-2834. doi: 10.1080/14786419.2016.1154053. Epub 2016 Mar 2.
PubMed 26936689Caruso S, Mauro D, Cariola M, Fava V, Rapisarda AMC, Cianci A. Randomized crossover study investigating daily versus on-demand vulvar Visnadine spray in women affected by female sexual arousal disorder. Gynecol Endocrinol. 2018 Feb;34(2):110-114. doi: 10.1080/09513590.2017.1354366. Epub 2017 Jul 27.
PubMed 28749253Schaefer O, Humpel M, Fritzemeier KH, Bohlmann R, Schleuning WD. 8-Prenyl naringenin is a potent ERalpha selective phytoestrogen present in hops and beer. J Steroid Biochem Mol Biol. 2003 Feb;84(2-3):359-60. doi: 10.1016/s0960-0760(03)00050-5. No abstract available.
PubMed 12711023
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a New Vaginal Cream Containing Visnadine, Prenylflavonoids and Bovine Colostrum in Postmenopausal Sexually Active Women Affected by Vulvovaginal Atrophy: a Prospective Cohort Analysis
- ClinicalTrials.gov ID
- NCT03281655
- Acronym / sponsor ID
- REFEEL-1
- Conditions
- Vulvovaginal Atrophy, Menopause
- Keywords
- Visnadine, Prenylflavonoids, Bovine colostrum, Sexual wellbeing
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- University of MessinaUniversity, hospital or other
- Collaborators
- University of Victoria, University of Athens
- Study start
- Dec 2016 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 13 Sep 2017 (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 effects of a new vaginal cream containing visnadine (0.30%), prenylflavonoids (0.10%) and bovine colostrum (1%) will be evaluated in post-menopausal sexually active women affected by vulvovaginal atrophy (VVA).
In a prospective cohort study, post-menopausal women affected by VVA will be enrolled. All women will undergo vaginal health index score (VHIS) evaluation and will complete the female sexual function index (FSFI) questionnaire at baseline evaluation (T0) and following 15 days of vaginal cream treatment with one application per day (T1). All the side effects will be recorded and an independent data safety and monitoring committee will evaluate the results of the study.
Detailed description
Sexual health plays a key role during women's lives from puberty to post-menopausal period and, for this reason, it has increasingly received public health, pharmaceutical, and medical attention. According to the study of women's health across the nation (SWAN), more than 75% of the middle-aged women reported that sex was moderately to extremely important; in addition, the menopausal transition was characterized by increasing pain during sexual intercourse and consequent decrease of sexual desire. Individual general health status, diabetes mellitus, cardiovascular diseases, other genitourinary diseases, psychiatric/psychological disorders, other chronic diseases and socio-demographic conditions may all influence post-menopausal sexual health. Although aging could be considered an independent risk factor for sexual dysfunction accumulating evidence suggests that vulvovaginal atrophy (VVA) is strongly associated with female sexual dysfunction (FSD) among sexually active postmenopausal women: in particular, VVA was found to be significantly associated with a global indication of FSD and difficulties with sexual desire, arousal, and orgasm. VVA often results from postmenopausal estrogen loss, which acts as a double-edged sword: on the one hand, it plays a detrimental action on woman's desire and arousal; on the other hand, it decreases the lubrication of the vagina before sexual activity and, consequently, causes pain during intercourse, precludes satisfaction and further decreases arousal.
Although several pharmacological approaches have been evaluated for the relief of VVA. Local estrogens are considered a safe option for VVA, although many clinicians are hesitant to prescribe them and many women reluctant to use them. In addition, non-hormonal treatments such as moisturizers and precoital vaginal lubricants could be considered a safer alternative, even in cancer patients. In this regard, visnadine, an active ingredient of the fruit of Ammi visnaga, showed powerful vasodilatory activity, due to the inhibitory effects on vascular smooth muscles mediated by Ca2+ entry through voltage-gated L-type Ca2+ channels. In addition, visnadine improves both female sexual function index (FSFI) and color Doppler sonography of clitoral blood flow. Furthermore, prenylflavonoids and phytoestrogens play a potent role as estrogen receptor (ER)-alpha selective agonist, thus they may counteract the effects of postmenopausal estrogen loss. Finally, a vaginal cream containing bovine colostrum has been shown to be effective in relieving vaginal dryness and other VVA symptoms in postmenopausal women, after 8 weeks of treatment. Based on this information, the investigators aim to evaluate the effects of a new vaginal cream containing visnadine, prenylflavonoids and bovine colostrum on vaginal health index score (VHIS) and FSFI in a cohort of postmenopausal sexually active women affected by VVA.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single cohort study
| Arm | Type | Receives |
|---|---|---|
| Vulvovaginal atrophy | Experimental | Drug: Visnadine, prenylflavonoids and bovine colostrumPostmenopausal sexually active women affected by vulvovaginal atrophy undergoing treatment (15 days, 1 application per day) with a vaginal cream containing visnadine, prenylflavonoids and bovine colostrum. |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- postmenopausal sexually active women affected by vulvovaginal atrophy.
Key exclusion criteria (3 listed)
- relevant comorbidities (chronic cardiovascular, immune, endocrine and metabolic diseases and cancers);
- smokers;
- who used any other kind of pharmacologic treatment (including the substances tested in this study) in the previous 3 months.
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 |
|---|---|---|
| Visnadine, prenylflavonoids and bovine colostrum15 days, 1 application per day, with a vaginal cream containing visnadine, prenylflavonoids and bovine colostrum. | Drug | Vulvovaginal atrophy |
Primary outcome
Vaginal health index score (VHIS) evaluation
Time frame: Post-treatment (15 days)
Elasticity, fluid volume and consistency, pH, epithelial integrity and moisture.
Female sexual function index (FSFI) questionnaire
Time frame: Post-treatment (15 days)
Desire, arousal, lubrication, orgasm, satisfaction and pain.
1 secondary outcome
Side effects
Time frame: Post-treatment (15 days)
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 25 Mar 2020.
- Background: PubMed 24559553Slater C, Robinson AJ. Sexual health in adolescents. Clin Dermatol. 2014 Mar-Apr;32(2):189-95. doi: 10.1016/j.clindermatol.2013.08.002.
- Background: PubMed 17394594Schwenkhagen A. Hormonal changes in menopause and implications on sexual health. J Sex Med. 2007 Mar;4 Suppl 3:220-6. doi: 10.1111/j.1743-6109.2007.00448.x.
- Background: PubMed 26953829McCabe MP, Sharlip ID, Lewis R, Atalla E, Balon R, Fisher AD, Laumann E, Lee SW, Segraves RT. Incidence and Prevalence of Sexual Dysfunction in Women and Men: A Consensus Statement from the Fourth International Consultation on Sexual Medicine 2015. J Sex Med. 2016 Feb;13(2):144-52. doi: 10.1016/j.jsxm.2015.12.034.
- Background: PubMed 19212271Avis NE, Brockwell S, Randolph JF Jr, Shen S, Cain VS, Ory M, Greendale GA. Longitudinal changes in sexual functioning as women transition through menopause: results from the Study of Women's Health Across the Nation. Menopause. 2009 May-Jun;16(3):442-52. doi: 10.1097/gme.0b013e3181948dd0.
- Background: PubMed 19436224Avis NE, Colvin A, Bromberger JT, Hess R, Matthews KA, Ory M, Schocken M. Change in health-related quality of life over the menopausal transition in a multiethnic cohort of middle-aged women: Study of Women's Health Across the Nation. Menopause. 2009 Sep-Oct;16(5):860-9. doi: 10.1097/gme.0b013e3181a3cdaf.
- Background: PubMed 16422789Dennerstein L, Hayes RD. Confronting the challenges: epidemiological study of female sexual dysfunction and the menopause. J Sex Med. 2005 Sep;2 Suppl 3:118-32. doi: 10.1111/j.1743-6109.2005.00128.x.
- Background: PubMed 16422862Hayes R, Dennerstein L. The impact of aging on sexual function and sexual dysfunction in women: a review of population-based studies. J Sex Med. 2005 May;2(3):317-30. doi: 10.1111/j.1743-6109.2005.20356.x.
- Background: PubMed 18698279Levine KB, Williams RE, Hartmann KE. Vulvovaginal atrophy is strongly associated with female sexual dysfunction among sexually active postmenopausal women. Menopause. 2008 Jul-Aug;15(4 Pt 1):661-6. doi: 10.1097/gme.0b013e31815a5168.
- Background: PubMed 27451325Nappi RE, Palacios S, Particco M, Panay N. The REVIVE (REal Women's VIews of Treatment Options for Menopausal Vaginal ChangEs) survey in Europe: Country-specific comparisons of postmenopausal women's perceptions, experiences and needs. Maturitas. 2016 Sep;91:81-90. doi: 10.1016/j.maturitas.2016.06.010. Epub 2016 Jun 15.
- Background: PubMed 26071816Castelo-Branco C, Biglia N, Nappi RE, Schwenkhagen A, Palacios S. Characteristics of post-menopausal women with genitourinary syndrome of menopause: Implications for vulvovaginal atrophy diagnosis and treatment selection. Maturitas. 2015 Aug;81(4):462-9. doi: 10.1016/j.maturitas.2015.05.007. Epub 2015 May 30.
- Background: PubMed 27577677Lethaby A, Ayeleke RO, Roberts H. Local oestrogen for vaginal atrophy in postmenopausal women. Cochrane Database Syst Rev. 2016 Aug 31;2016(8):CD001500. doi: 10.1002/14651858.CD001500.pub3.
- Background: PubMed 18087605Derzko C, Elliott S, Lam W. Management of sexual dysfunction in postmenopausal breast cancer patients taking adjuvant aromatase inhibitor therapy. Curr Oncol. 2007 Dec;14 Suppl 1(Suppl 1):S20-40. doi: 10.3747/co.2007.151.
- Individual participant dataSharing planned: Undecided
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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.
Antonio Simone Laganà, M.D. principal investigator
University of Messina
Salvatore Giovanni Vitale, M.D. principal investigator
University of Messina
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Visnadine, prenylflavonoids and bovine colostrum in people with Vulvovaginal Atrophy and Menopause, run by University of Messina.
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 1 inclusion and 3 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 25 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Vaginal health index score (VHIS) evaluation (time frame: Post-treatment (15 days)). 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 NCT03281655, which also lists 16 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 25 Mar 2020.