<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/NCT03831165</url>
  </required_header>
  <id_info>
    <org_study_id>1215208</org_study_id>
    <nct_id>NCT03831165</nct_id>
  </id_info>
  <brief_title>Melatonin Effects on Genital Herpes in Brazilian Women</brief_title>
  <official_title>Effects of Melatonin in the Treatment of Genital Herpes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Sao Paulo General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Sao Paulo General Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Genital herpes is a common and increasingly-common infection worldwide. The annual incidence&#xD;
      in the United States is 1.75 per 1000 inhabitants. The etiologic agent is the herpes type 1&#xD;
      and 2 strains simplex virus. Classical Treatment is with acyclovir which decreases the&#xD;
      duration of the disease and prevents rashes but has no curative effect. Also, studies show&#xD;
      herpes resistance to acyclovir which has stimulating research into new drugs to treat this&#xD;
      condition. Authors suggest melatonin way be a therapeutic agent in herpetic disease due to&#xD;
      its modulatory action in immune and inflammatory responses when administered in adequate&#xD;
      doses. Therefore, the aim of this study is to evaluate the effects of melatonin in the&#xD;
      treatment of genital herpes as well as compare it to acyclovir in a double-blind, prospective&#xD;
      and randomized, investigation. Outcome measures will include clinical evaluation of patients&#xD;
      and laboratory endpoints.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The authors have investigate the relationship of estrogen-dependent malignant tumors with&#xD;
      reduced levels of melatonin. It is speculated that the indoleamine can be classified as&#xD;
      anti-estrogenic drug, both by its action on estrogen synthesis with aromatase inhibition and&#xD;
      by its interference with estrogen receptors. Experimentally melatonin prevents promotion and&#xD;
      growth of mammary tumors in rodents, probably by interacting with epithelial cell receptor;&#xD;
      increasing local immunity by acting as an antioxidant agent and by inhibiting telomerase&#xD;
      activity in tumor cells .&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2, 2015</start_date>
  <completion_date type="Actual">December 28, 2021</completion_date>
  <primary_completion_date type="Actual">September 2021</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <intervention_model_description>The patients will be divided into three groups. One group (group A) will receive a bottle with 360 pills of acyclovir 200 mg. These individuals will be instructed to take 2 tablets of 200mg acyclovir (400 mg) twice daily for 90 days. Group B will receive 90 tablets of 30 mg of melatonin, the tablet will be used as 01 tablet daily for 90 days. Group C will receive 90 tablets of melatonin 3mg, and 360 tablets of acyclovir dose is 1 tablet per day for 90 days.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
    <masking_description>The patients will be treated at the Clinic of Gynecology, University of Sao Paulo during a total of 04 visits. In the first and fourth visits, patients will be sent to the laboratory of the University Hospital for collecting the cluster of differentiation 4 cells, interleukin-2 and serology for herpes.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Clinical disease activity</measure>
    <time_frame>2 years</time_frame>
    <description>Number of participants with clinical signals of herpes genial activity</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">90</enrollment>
  <condition>Genital Herpes</condition>
  <arm_group>
    <arm_group_label>melatonin 3mg + Acyclovir 400mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group I - melatonin 3mg + Acyclovir 400mg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Acyclovir 400mg</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Group II - Acyclovir 400mg twice a day</description>
  </arm_group>
  <arm_group>
    <arm_group_label>placebo + melatonin 3mg</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Group III - placebo + melatonin 3mg</description>
  </arm_group>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>Melatonin 3 mg</intervention_name>
    <description>melatonin and placebo</description>
    <arm_group_label>Acyclovir 400mg</arm_group_label>
    <arm_group_label>melatonin 3mg + Acyclovir 400mg</arm_group_label>
    <arm_group_label>placebo + melatonin 3mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Acyclovir</intervention_name>
    <description>Only acyclovir 200 mg twice a day</description>
    <arm_group_label>Acyclovir 400mg</arm_group_label>
    <arm_group_label>melatonin 3mg + Acyclovir 400mg</arm_group_label>
    <arm_group_label>placebo + melatonin 3mg</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  clinical and laboratory diagnosis of genital herpes&#xD;
&#xD;
          -  real time polymerase chain reaction for herpes type 2&#xD;
&#xD;
          -  serology&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  immunodeficiencies&#xD;
&#xD;
          -  pregnant women&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Female only</gender_description>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>49 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Edmund C Baracat, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Universidade de Sao Paulo General Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Avenida Doutor Eneas Carvalho de Aguiar 255 10 andar</name>
      <address>
        <city>São Paulo</city>
        <state>SP</state>
        <zip>05403000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo</name>
      <address>
        <city>Sao Paulo</city>
        <zip>05403000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>July 3, 2018</study_first_submitted>
  <study_first_submitted_qc>February 1, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 5, 2019</study_first_posted>
  <last_update_submitted>January 5, 2022</last_update_submitted>
  <last_update_submitted_qc>January 5, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 11, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>acyclovir</keyword>
  <keyword>melatonin</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Herpes Simplex</mesh_term>
    <mesh_term>Herpes Genitalis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acyclovir</mesh_term>
    <mesh_term>Melatonin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03831165
org study id: 1215208
nct id: NCT03831165
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: Yes
is us export: Yes
Genital herpes is a common and increasingly-common infection worldwide. The annual incidence
      in the United States is 1.75 per 1000 inhabitants. The etiologic agent is the herpes type 1
      and 2 strains simplex virus. Classical Treatment is with acyclovir which decreases the
      duration of the disease and prevents rashes but has no curative effect. Also, studies show
      herpes resistance to acyclovir which has stimulating research into new drugs to treat this
      condition. Authors suggest melatonin way be a therapeutic agent in herpetic disease due to
      its modulatory action in immune and inflammatory responses when administered in adequate
      doses. Therefore, the aim of this study is to evaluate the effects of melatonin in the
      treatment of genital herpes as well as compare it to acyclovir in a double-blind, prospective
      and randomized, investigation. Outcome measures will include clinical evaluation of patients
      and laboratory endpoints.
The authors have investigate the relationship of estrogen-dependent malignant tumors with
      reduced levels of melatonin. It is speculated that the indoleamine can be classified as
      anti-estrogenic drug, both by its action on estrogen synthesis with aromatase inhibition and
      by its interference with estrogen receptors. Experimentally melatonin prevents promotion and
      growth of mammary tumors in rodents, probably by interacting with epithelial cell receptor;
      increasing local immunity by acting as an antioxidant agent and by inhibiting telomerase
      activity in tumor cells .
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: The patients will be divided into three groups. One group (group A) will receive a bottle with 360 pills of acyclovir 200 mg. These individuals will be instructed to take 2 tablets of 200mg acyclovir (400 mg) twice daily for 90 days. Group B will receive 90 tablets of 30 mg of melatonin, the tablet will be used as 01 tablet daily for 90 days. Group C will receive 90 tablets of melatonin 3mg, and 360 tablets of acyclovir dose is 1 tablet per day for 90 days.
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
masking description: The patients will be treated at the Clinic of Gynecology, University of Sao Paulo during a total of 04 visits. In the first and fourth visits, patients will be sent to the laboratory of the University Hospital for collecting the cluster of differentiation 4 cells, interleukin-2 and serology for herpes.
measure: Clinical disease activity
time frame: 2 years
description: Number of participants with clinical signals of herpes genial activity
arm group label: melatonin 3mg + Acyclovir 400mg
arm group type: Experimental
description: Group I - melatonin 3mg + Acyclovir 400mg
arm group label: Acyclovir 400mg
arm group type: Active Comparator
description: Group II - Acyclovir 400mg twice a day
arm group label: placebo + melatonin 3mg
arm group type: Placebo Comparator
description: Group III - placebo + melatonin 3mg
intervention type: Combination Product
intervention name: Melatonin 3 mg
description: melatonin and placebo
arm group label: Acyclovir 400mg
arm group label: melatonin 3mg + Acyclovir 400mg
arm group label: placebo + melatonin 3mg
intervention type: Drug
intervention name: Acyclovir
description: Only acyclovir 200 mg twice a day
arm group label: Acyclovir 400mg
arm group label: melatonin 3mg + Acyclovir 400mg
arm group label: placebo + melatonin 3mg
criteria: 
gender: Female
gender based: Yes
gender description: Female only
minimum age: 15 Years
maximum age: 49 Years
healthy volunteers: No
last name: Edmund C Baracat, PhD
role: Study Director
affiliation: Universidade de Sao Paulo General Hospital
facility: 
facility: 
country: Brazil
responsible party type: Sponsor
mesh term: Herpes Simplex
mesh term: Herpes Genitalis
mesh term: Acyclovir
mesh term: Melatonin
sharing ipd: No