<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/NCT04498013</url>
  </required_header>
  <id_info>
    <org_study_id>453190</org_study_id>
    <nct_id>NCT04498013</nct_id>
  </id_info>
  <brief_title>Study of the Effects of Cyclodynon on Reducing the Cumulative Risk of Breast Cancer Development in a Female Aged 40-52</brief_title>
  <acronym>BIO-CYCL</acronym>
  <official_title>A Clinical Study of the Effects of Cyclodynon® Compared With a Control Group on Reducing the Cumulative Risk of Breast Cancer Development in a Female Population Aged 40-52 Years With Mastodynia and BI-RADS Category 3</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dr. Struk Tetiana</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Bionorica SE</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>National University of Pharmacy</source>
  <oversight_info>
    <has_dmc>No</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>
      Increased mammographic density of mammary gland tissues and hyperprolactinaemia are regarded&#xD;
      as one of the risk factors for the development of breast cancer in women aged 40 to 52 years,&#xD;
      which necessitates closer monitoring of the mammary gland and can be considered as&#xD;
      modifiable. The herbal drug Cyclodynone® has a dopaminergic effect on the hypothalamus, which&#xD;
      causes its inhibitory effect on the secretion of prolactin. At present, a significant&#xD;
      positive clinical and scientific experience has been accumulated in the use of the&#xD;
      Cyclodynone® for the treatment of benign breast dysplasias against a background of mild&#xD;
      hyperprolactinaemia in women of reproductive age. Demonstration of the positive effect of&#xD;
      this drug on the reduction of hyperprolactinemia, mammographic density of MF, evaluation on&#xD;
      the scale BI-RADS would justify its application for the modification of this risk factor in&#xD;
      women aged 40 to 52 years.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Hypothesis: Increased mammographic density of mammary gland tissues and hyperprolactinaemia&#xD;
      are regarded as one of the risk factors for the development of breast cancer in women aged 40&#xD;
      to 52 years, which necessitates closer monitoring of the mammary gland. However, this risk&#xD;
      factor can be considered as modifiable. The drug Cyclodynone® (contains 4 mg of special&#xD;
      extract of dried fruits of Chaste Berry (Vitex agnus-castus)) has a dopaminergic effect on&#xD;
      the hypothalamus, which causes its inhibitory effect on the secretion of prolactin. At&#xD;
      present, a significant positive clinical and scientific experience has been accumulated in&#xD;
      the use of the Cyclodynone® for the treatment of benign breast dysplasias against a&#xD;
      background of mild hyperprolactinaemia in women of reproductive age. However, the experience&#xD;
      of using Cyclodynone® in women older than 40-52 years with increased density or dyshormonal&#xD;
      pathology of breast cancer is limited. Demonstration of the positive effect of this drug on&#xD;
      the reduction of hyperprolactinemia, mammographic density of MF, evaluation on the scale&#xD;
      BI-RADS would justify its application for the modification of this risk factor in women aged&#xD;
      40 to 52 years.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 22, 2020</start_date>
  <completion_date type="Anticipated">May 1, 2022</completion_date>
  <primary_completion_date type="Anticipated">April 1, 2022</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>Parallel Assignment</intervention_model>
    <intervention_model_description>Female patients aged 40 to 52 years (inclusive) with mastodynia and BI-RADS category 3, who meet the requirements of inclusion/exclusion criteria will be randomized in 2 groups. The main group will be treated with Cyclodynon 1 tab per day - 6 month in addition to lifestyle modification. The control group lifestyle modification only. Dynamics of mammographic breast density (changing in BI-RADS score of category 3).</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mammographic density</measure>
    <time_frame>6 month</time_frame>
    <description>Decrease in the mammographic density determined by a mammographic breast examination at Visit 5 compared to baseline (Visit 1).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>BI-RADS indicator</measure>
    <time_frame>6 month</time_frame>
    <description>Dynamics of BI-RADS indicator determined by a mammographic breast examination.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Mammographic Breast Density</condition>
  <arm_group>
    <arm_group_label>Treatment group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will be treated with Cyclodynon 1 tablet per day 6 month in addition to lifestyle modification</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Lifestyle modification only</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cyclodynon</intervention_name>
    <description>Cyclodynon 1 tablet a day during 6 menthes period.</description>
    <arm_group_label>Treatment group</arm_group_label>
    <other_name>Chaste Berry (Vitex agnus-castus) Extact , 4 mg.</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Lifestyl modification</intervention_name>
    <description>Measures to normalize the hygiene of work and rest. A diet aimed at achieving an optimal body mass index. Teaching relaxation techniques to increase resistance to chronic stress.</description>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_label>Treatment group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female patients aged 40 to 52 years (inclusive) with mastodynia and BI-RADS category&#xD;
             3.&#xD;
&#xD;
          -  The patient's written informed consent to participate in any study-related procedures.&#xD;
&#xD;
          -  According to the Investigator, the patient's ability to comply with all the&#xD;
             requirements of the study protocol, i.e. the patient's ability to cooperate&#xD;
             adequately.&#xD;
&#xD;
          -  Patients who do not have chronic diseases of the cardiovascular system, neuroendocrine&#xD;
             system, kidneys, liver, gastrointestinal tract, respiratory system, skin in the&#xD;
             decompensation stage.&#xD;
&#xD;
          -  Consent to use reliable, evidence-based contraceptive methods (double containing the&#xD;
             following types: hormonal, barrier, intrauterine spiral, etc.) throughout the study&#xD;
             (from the time of the Informed Consent to Visit 6) .&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Hypersensitivity to the components of the IMP.&#xD;
&#xD;
          -  Burdened history of allergies.&#xD;
&#xD;
          -  Participation in another clinical study less than 90 days before signing the informed&#xD;
             consent form.&#xD;
&#xD;
          -  History of cancer.&#xD;
&#xD;
          -  Pregnancy or lactation.&#xD;
&#xD;
          -  Administration of dopamine agonists, dopamine antagonists, oestrogens and&#xD;
             antiestrogens, dopamine.&#xD;
&#xD;
          -  Secondary amenorrhoea within 6 months or more.&#xD;
&#xD;
          -  Surgical, pharmacological or physiological menopause (except hysterectomy).&#xD;
&#xD;
          -  The prolactin level is more than 80 ng/mL.&#xD;
&#xD;
          -  Other reasons which make the patient's participation in the study undesirable,&#xD;
             according to the Investigator.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Research refers to the study of a pathological condition that occurs (applicable) only in the female population.</gender_description>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>52 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tetiana Struk, Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>NFAU</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Tetiana Struk, Ph.D.</last_name>
    <phone>+380507335050</phone>
    <email>struk.tatyana.kh@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Popov Alexet, Ph.D</last_name>
    <phone>+380973631791</phone>
    <email>oleksii.s.popov@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Clinical and diagnostics center</name>
      <address>
        <city>Kharkiv</city>
        <zip>61057</zip>
        <country>Ukraine</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Tetiana Struk, Ph.D</last_name>
      <phone>+380507335050</phone>
      <email>struk.tatyana.kh@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Oleksii Popov, Ph.D</last_name>
      <phone>+380973631791</phone>
      <email>oleksii.s.popov@gmail.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Ukraine</country>
  </location_countries>
  <reference>
    <citation>Lee CI, Chen LE, Elmore JG. Risk-based Breast Cancer Screening: Implications of Breast Density. Med Clin North Am. 2017 Jul;101(4):725-741. doi: 10.1016/j.mcna.2017.03.005.</citation>
    <PMID>28577623</PMID>
  </reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 31, 2020</study_first_submitted>
  <study_first_submitted_qc>July 31, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2020</study_first_posted>
  <last_update_submitted>July 31, 2020</last_update_submitted>
  <last_update_submitted_qc>July 31, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>National University of Pharmacy</investigator_affiliation>
    <investigator_full_name>Dr. Struk Tetiana</investigator_full_name>
    <investigator_title>Associate professor</investigator_title>
  </responsible_party>
  <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/NCT04498013
org study id: 453190
nct id: NCT04498013
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Increased mammographic density of mammary gland tissues and hyperprolactinaemia are regarded
      as one of the risk factors for the development of breast cancer in women aged 40 to 52 years,
      which necessitates closer monitoring of the mammary gland and can be considered as
      modifiable. The herbal drug Cyclodynone® has a dopaminergic effect on the hypothalamus, which
      causes its inhibitory effect on the secretion of prolactin. At present, a significant
      positive clinical and scientific experience has been accumulated in the use of the
      Cyclodynone® for the treatment of benign breast dysplasias against a background of mild
      hyperprolactinaemia in women of reproductive age. Demonstration of the positive effect of
      this drug on the reduction of hyperprolactinemia, mammographic density of MF, evaluation on
      the scale BI-RADS would justify its application for the modification of this risk factor in
      women aged 40 to 52 years.
Hypothesis: Increased mammographic density of mammary gland tissues and hyperprolactinaemia
      are regarded as one of the risk factors for the development of breast cancer in women aged 40
      to 52 years, which necessitates closer monitoring of the mammary gland. However, this risk
      factor can be considered as modifiable. The drug Cyclodynone® (contains 4 mg of special
      extract of dried fruits of Chaste Berry (Vitex agnus-castus)) has a dopaminergic effect on
      the hypothalamus, which causes its inhibitory effect on the secretion of prolactin. At
      present, a significant positive clinical and scientific experience has been accumulated in
      the use of the Cyclodynone® for the treatment of benign breast dysplasias against a
      background of mild hyperprolactinaemia in women of reproductive age. However, the experience
      of using Cyclodynone® in women older than 40-52 years with increased density or dyshormonal
      pathology of breast cancer is limited. Demonstration of the positive effect of this drug on
      the reduction of hyperprolactinemia, mammographic density of MF, evaluation on the scale
      BI-RADS would justify its application for the modification of this risk factor in women aged
      40 to 52 years.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Female patients aged 40 to 52 years (inclusive) with mastodynia and BI-RADS category 3, who meet the requirements of inclusion/exclusion criteria will be randomized in 2 groups. The main group will be treated with Cyclodynon 1 tab per day - 6 month in addition to lifestyle modification. The control group lifestyle modification only. Dynamics of mammographic breast density (changing in BI-RADS score of category 3).
primary purpose: Treatment
masking: None (Open Label)
measure: Mammographic density
time frame: 6 month
description: Decrease in the mammographic density determined by a mammographic breast examination at Visit 5 compared to baseline (Visit 1).
measure: BI-RADS indicator
time frame: 6 month
description: Dynamics of BI-RADS indicator determined by a mammographic breast examination.
arm group label: Treatment group
arm group type: Experimental
description: Patients will be treated with Cyclodynon 1 tablet per day 6 month in addition to lifestyle modification
arm group label: Control group
arm group type: Other
description: Lifestyle modification only
intervention type: Drug
intervention name: Cyclodynon
description: Cyclodynon 1 tablet a day during 6 menthes period.
arm group label: Treatment group
other name: Chaste Berry (Vitex agnus-castus) Extact , 4 mg.
intervention type: Behavioral
intervention name: Lifestyl modification
description: Measures to normalize the hygiene of work and rest. A diet aimed at achieving an optimal body mass index. Teaching relaxation techniques to increase resistance to chronic stress.
arm group label: Control group
arm group label: Treatment group
criteria: 
gender: Female
gender based: Yes
gender description: Research refers to the study of a pathological condition that occurs (applicable) only in the female population.
minimum age: 40 Years
maximum age: 52 Years
healthy volunteers: No
last name: Tetiana Struk, Ph.D
role: Principal Investigator
affiliation: NFAU
last name: Tetiana Struk, Ph.D.
phone: +380507335050
email: struk.tatyana.kh@gmail.com
last name: Popov Alexet, Ph.D
phone: +380973631791
email: oleksii.s.popov@gmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: Ukraine
citation: Lee CI, Chen LE, Elmore JG. Risk-based Breast Cancer Screening: Implications of Breast Density. Med Clin North Am. 2017 Jul;101(4):725-741. doi: 10.1016/j.mcna.2017.03.005.
PMID: 28577623
responsible party type: Sponsor-Investigator
investigator affiliation: National University of Pharmacy
investigator full name: Dr. Struk Tetiana
investigator title: Associate professor
sharing ipd: No