<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03281655</url>
  </required_header>
  <id_info>
    <org_study_id>REFEEL-1</org_study_id>
    <nct_id>NCT03281655</nct_id>
  </id_info>
  <brief_title>Visnadine, Prenylflavonoids and Bovine Colostrum to Treat Vulvovaginal Atrophy in Postmenopausal Women</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Messina</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Victoria</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Athens</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Messina</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The effects of a new vaginal cream containing visnadine (0.30%), prenylflavonoids (0.10%) and&#xD;
      bovine colostrum (1%) will be evaluated in post-menopausal sexually active women affected by&#xD;
      vulvovaginal atrophy (VVA).&#xD;
&#xD;
      In a prospective cohort study, post-menopausal women affected by VVA will be enrolled. All&#xD;
      women will undergo vaginal health index score (VHIS) evaluation and will complete the female&#xD;
      sexual function index (FSFI) questionnaire at baseline evaluation (T0) and following 15 days&#xD;
      of vaginal cream treatment with one application per day (T1). All the side effects will be&#xD;
      recorded and an independent data safety and monitoring committee will evaluate the results of&#xD;
      the study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Sexual health plays a key role during women's lives from puberty to post-menopausal period&#xD;
      and, for this reason, it has increasingly received public health, pharmaceutical, and medical&#xD;
      attention. According to the study of women's health across the nation (SWAN), more than 75%&#xD;
      of the middle-aged women reported that sex was moderately to extremely important; in&#xD;
      addition, the menopausal transition was characterized by increasing pain during sexual&#xD;
      intercourse and consequent decrease of sexual desire. Individual general health status,&#xD;
      diabetes mellitus, cardiovascular diseases, other genitourinary diseases,&#xD;
      psychiatric/psychological disorders, other chronic diseases and socio-demographic conditions&#xD;
      may all influence post-menopausal sexual health. Although aging could be considered an&#xD;
      independent risk factor for sexual dysfunction accumulating evidence suggests that&#xD;
      vulvovaginal atrophy (VVA) is strongly associated with female sexual dysfunction (FSD) among&#xD;
      sexually active postmenopausal women: in particular, VVA was found to be significantly&#xD;
      associated with a global indication of FSD and difficulties with sexual desire, arousal, and&#xD;
      orgasm. VVA often results from postmenopausal estrogen loss, which acts as a double-edged&#xD;
      sword: on the one hand, it plays a detrimental action on woman's desire and arousal; on the&#xD;
      other hand, it decreases the lubrication of the vagina before sexual activity and,&#xD;
      consequently, causes pain during intercourse, precludes satisfaction and further decreases&#xD;
      arousal.&#xD;
&#xD;
      Although several pharmacological approaches have been evaluated for the relief of VVA. Local&#xD;
      estrogens are considered a safe option for VVA, although many clinicians are hesitant to&#xD;
      prescribe them and many women reluctant to use them. In addition, non-hormonal treatments&#xD;
      such as moisturizers and precoital vaginal lubricants could be considered a safer&#xD;
      alternative, even in cancer patients. In this regard, visnadine, an active ingredient of the&#xD;
      fruit of Ammi visnaga, showed powerful vasodilatory activity, due to the inhibitory effects&#xD;
      on vascular smooth muscles mediated by Ca2+ entry through voltage-gated L-type Ca2+ channels.&#xD;
      In addition, visnadine improves both female sexual function index (FSFI) and color Doppler&#xD;
      sonography of clitoral blood flow. Furthermore, prenylflavonoids and phytoestrogens play a&#xD;
      potent role as estrogen receptor (ER)-alpha selective agonist, thus they may counteract the&#xD;
      effects of postmenopausal estrogen loss. Finally, a vaginal cream containing bovine colostrum&#xD;
      has been shown to be effective in relieving vaginal dryness and other VVA symptoms in&#xD;
      postmenopausal women, after 8 weeks of treatment. Based on this information, the&#xD;
      investigators aim to evaluate the effects of a new vaginal cream containing visnadine,&#xD;
      prenylflavonoids and bovine colostrum on vaginal health index score (VHIS) and FSFI in a&#xD;
      cohort of postmenopausal sexually active women affected by VVA.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2016</start_date>
  <completion_date type="Actual">January 2018</completion_date>
  <primary_completion_date type="Actual">May 2017</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Single cohort study</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Vaginal health index score (VHIS) evaluation</measure>
    <time_frame>Post-treatment (15 days)</time_frame>
    <description>Elasticity, fluid volume and consistency, pH, epithelial integrity and moisture.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Female sexual function index (FSFI) questionnaire</measure>
    <time_frame>Post-treatment (15 days)</time_frame>
    <description>Desire, arousal, lubrication, orgasm, satisfaction and pain.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Side effects</measure>
    <time_frame>Post-treatment (15 days)</time_frame>
    <description>Number of side effects during/after the treatment.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">54</enrollment>
  <condition>Vulvovaginal Atrophy</condition>
  <condition>Menopause</condition>
  <arm_group>
    <arm_group_label>Vulvovaginal atrophy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Visnadine, prenylflavonoids and bovine colostrum</intervention_name>
    <description>15 days, 1 application per day, with a vaginal cream containing visnadine, prenylflavonoids and bovine colostrum.</description>
    <arm_group_label>Vulvovaginal atrophy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  postmenopausal sexually active women affected by vulvovaginal atrophy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  relevant comorbidities (chronic cardiovascular, immune, endocrine and metabolic&#xD;
             diseases and cancers);&#xD;
&#xD;
          -  smokers;&#xD;
&#xD;
          -  who used any other kind of pharmacologic treatment (including the substances tested in&#xD;
             this study) in the previous 3 months.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Antonio Simone Laganà, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Messina</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Salvatore Giovanni Vitale, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Messina</affiliation>
  </overall_official>
  <reference>
    <citation>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.</citation>
    <PMID>24559553</PMID>
  </reference>
  <reference>
    <citation>Schwenkhagen 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.</citation>
    <PMID>17394594</PMID>
  </reference>
  <reference>
    <citation>McCabe 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.</citation>
    <PMID>26953829</PMID>
  </reference>
  <reference>
    <citation>Avis 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.</citation>
    <PMID>19212271</PMID>
  </reference>
  <reference>
    <citation>Avis 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.</citation>
    <PMID>19436224</PMID>
  </reference>
  <reference>
    <citation>Dennerstein 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.</citation>
    <PMID>16422789</PMID>
  </reference>
  <reference>
    <citation>Hayes 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.</citation>
    <PMID>16422862</PMID>
  </reference>
  <reference>
    <citation>Levine 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.</citation>
    <PMID>18698279</PMID>
  </reference>
  <reference>
    <citation>Nappi 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.</citation>
    <PMID>27451325</PMID>
  </reference>
  <reference>
    <citation>Castelo-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.</citation>
    <PMID>26071816</PMID>
  </reference>
  <reference>
    <citation>Lethaby 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.</citation>
    <PMID>27577677</PMID>
  </reference>
  <reference>
    <citation>Derzko 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.</citation>
    <PMID>18087605</PMID>
  </reference>
  <reference>
    <citation>Bassino 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.</citation>
    <PMID>26936689</PMID>
  </reference>
  <reference>
    <citation>Caruso 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.</citation>
    <PMID>28749253</PMID>
  </reference>
  <reference>
    <citation>Schaefer 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.</citation>
    <PMID>12711023</PMID>
  </reference>
  <reference>
    <citation>Nappi RE, Cagnacci A, Becorpi AM, Nappi C, Paoletti AM, Busacca M, Martella S, Bellafronte M, Tredici Z, Di Carlo C, Corda V, Vignali M, Bagolan M, Sardina M. Monurelle Biogel(R) vaginal gel in the treatment of vaginal dryness in postmenopausal women. Climacteric. 2017 Oct;20(5):467-475. doi: 10.1080/13697137.2017.1335703. Epub 2017 Jun 28.</citation>
    <PMID>28657769</PMID>
  </reference>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>September 8, 2017</study_first_submitted>
  <study_first_submitted_qc>September 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 13, 2017</study_first_posted>
  <last_update_submitted>March 23, 2020</last_update_submitted>
  <last_update_submitted_qc>March 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 25, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Messina</investigator_affiliation>
    <investigator_full_name>Antonio Simone Laganà</investigator_full_name>
    <investigator_title>Medical Doctor</investigator_title>
  </responsible_party>
  <keyword>Visnadine</keyword>
  <keyword>Prenylflavonoids</keyword>
  <keyword>Bovine colostrum</keyword>
  <keyword>Sexual wellbeing</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atrophy</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03281655
org study id: REFEEL-1
nct id: NCT03281655
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Single cohort study
primary purpose: Treatment
masking: None (Open Label)
measure: Vaginal health index score (VHIS) evaluation
time frame: Post-treatment (15 days)
description: Elasticity, fluid volume and consistency, pH, epithelial integrity and moisture.
measure: Female sexual function index (FSFI) questionnaire
time frame: Post-treatment (15 days)
description: Desire, arousal, lubrication, orgasm, satisfaction and pain.
measure: Side effects
time frame: Post-treatment (15 days)
description: Number of side effects during/after the treatment.
arm group label: Vulvovaginal atrophy
arm group type: Experimental
description: 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.
intervention type: Drug
intervention name: Visnadine, prenylflavonoids and bovine colostrum
description: 15 days, 1 application per day, with a vaginal cream containing visnadine, prenylflavonoids and bovine colostrum.
arm group label: Vulvovaginal atrophy
criteria: 
gender: Female
minimum age: 45 Years
maximum age: 70 Years
healthy volunteers: No
last name: Antonio Simone Laganà, M.D.
role: Principal Investigator
affiliation: University of Messina
last name: Salvatore Giovanni Vitale, M.D.
role: Principal Investigator
affiliation: University of Messina
citation: 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.
PMID: 24559553
citation: Schwenkhagen 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.
PMID: 17394594
citation: McCabe 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.
PMID: 26953829
citation: Avis 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.
PMID: 19212271
citation: Avis 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.
PMID: 19436224
citation: Dennerstein 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.
PMID: 16422789
citation: Hayes 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.
PMID: 16422862
citation: Levine 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.
PMID: 18698279
citation: Nappi 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.
PMID: 27451325
citation: Castelo-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.
PMID: 26071816
citation: Lethaby 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.
PMID: 27577677
citation: Derzko 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.
PMID: 18087605
citation: Bassino 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.
PMID: 26936689
citation: Caruso 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.
PMID: 28749253
citation: Schaefer 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.
PMID: 12711023
citation: Nappi RE, Cagnacci A, Becorpi AM, Nappi C, Paoletti AM, Busacca M, Martella S, Bellafronte M, Tredici Z, Di Carlo C, Corda V, Vignali M, Bagolan M, Sardina M. Monurelle Biogel(R) vaginal gel in the treatment of vaginal dryness in postmenopausal women. Climacteric. 2017 Oct;20(5):467-475. doi: 10.1080/13697137.2017.1335703. Epub 2017 Jun 28.
PMID: 28657769
responsible party type: Principal Investigator
investigator affiliation: University of Messina
investigator full name: Antonio Simone Laganà
investigator title: Medical Doctor
mesh term: Atrophy
sharing ipd: Undecided