<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/NCT01724658</url>
  </required_header>
  <id_info>
    <org_study_id>CU0115</org_study_id>
    <nct_id>NCT01724658</nct_id>
  </id_info>
  <brief_title>Effectiveness of Testosterone Undecanoate to Improve Sexual Function in Postmenopausal Women</brief_title>
  <official_title>Effectiveness of Testosterone Undecanoate to Improve Sexual Function in Postmenopausal Women</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chulalongkorn University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chulalongkorn University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Additional testosterone undecanoate can improve female sexual function in postmenopausal&#xD;
      women which one aspects of quality of life. The dose adjustment can reduce incidence of&#xD;
      adverse effects and low cost of treatment with effective outcome.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Research Question:&#xD;
&#xD;
      &quot; Does oral testosterone undecanoate improve sexual problem in postmenopausal women? &quot; Type&#xD;
      Research:Clinical research&#xD;
&#xD;
      Study design:&#xD;
&#xD;
      Randomized double-blinded placebo controlled trial&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2012</start_date>
  <completion_date type="Actual">May 2013</completion_date>
  <primary_completion_date type="Actual">April 2013</primary_completion_date>
  <phase>Phase 2</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>female sexual function index score</measure>
    <time_frame>8 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>adverse effects of the drug</measure>
    <time_frame>8 week</time_frame>
    <description>weight gain&#xD;
acne&#xD;
hirsutism.&#xD;
vaginal bleeding</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">70</enrollment>
  <condition>Female Sexual Dysfunction</condition>
  <arm_group>
    <arm_group_label>Testosterone undecanoate</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>testosterone undecanoate 40 mg orally twice a week plus progynova 1mg oral daily</description>
  </arm_group>
  <arm_group>
    <arm_group_label>placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>placebo twice a week with progynova 1 mg oral daily</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Testosterone undecanoate</intervention_name>
    <description>testosterone undecanoate 40 mg orally twice a week</description>
    <arm_group_label>Testosterone undecanoate</arm_group_label>
    <other_name>Andriol</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>placebo</intervention_name>
    <description>placebo orally twice a week with progynova 1 mg oral daily</description>
    <arm_group_label>placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  postmenopausal women with age between 40-60 years&#xD;
&#xD;
          -  Women complain about her sexual problem and her score of Female Sexual Function Index&#xD;
             ≤ 26.5&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  women with previous use of hormonal replacement or anti-psychiatric drugs within 3&#xD;
             months&#xD;
&#xD;
          -  women with history of or present premalignancies/malignancies&#xD;
&#xD;
          -  women present with liver disease or abnormal liver enzyme&#xD;
&#xD;
          -  women with active cardiovascular, cerebrovascular or thromboembolic disorders&#xD;
&#xD;
          -  women with Present psychiatric disease&#xD;
&#xD;
          -  Partner have sexual dysfunction&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Reuthairat Tungmunsakulchai, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Menopause unit of Chulalongkorn hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>King Chulalongkorn memorial hospital</name>
      <address>
        <city>Bankok</city>
        <zip>10330</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Thailand</country>
  </location_countries>
  <results_reference>
    <citation>Floter A, Nathorst-Boos J, Carlstrom K, von Schoultz B. Addition of testosterone to estrogen replacement therapy in oophorectomized women: effects on sexuality and well-being. Climacteric. 2002 Dec;5(4):357-65.</citation>
    <PMID>12626215</PMID>
  </results_reference>
  <verification_date>January 2014</verification_date>
  <study_first_submitted>October 12, 2012</study_first_submitted>
  <study_first_submitted_qc>November 7, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 12, 2012</study_first_posted>
  <last_update_submitted>January 28, 2014</last_update_submitted>
  <last_update_submitted_qc>January 28, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 29, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>female sexual function</keyword>
  <keyword>postmenopause</keyword>
  <keyword>testosterone</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Methyltestosterone</mesh_term>
    <mesh_term>Testosterone</mesh_term>
    <mesh_term>Testosterone undecanoate</mesh_term>
    <mesh_term>Testosterone enanthate</mesh_term>
    <mesh_term>Testosterone 17 beta-cypionate</mesh_term>
  </intervention_browse>
  <pending_results>
    <submitted>May 19, 2014</submitted>
    <submission_canceled>Unknown</submission_canceled>
    <submitted>January 23, 2015</submitted>
    <returned>February 6, 2015</returned>
  </pending_results>
  <!-- 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/NCT01724658
org study id: CU0115
nct id: NCT01724658
lead sponsor: 
has dmc: Yes
Additional testosterone undecanoate can improve female sexual function in postmenopausal
      women which one aspects of quality of life. The dose adjustment can reduce incidence of
      adverse effects and low cost of treatment with effective outcome.
Research Question:

      " Does oral testosterone undecanoate improve sexual problem in postmenopausal women? " Type
      Research:Clinical research

      Study design:

      Randomized double-blinded placebo controlled trial
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: female sexual function index score
time frame: 8 weeks
measure: adverse effects of the drug
time frame: 8 week
description: weight gain
acne
hirsutism.
vaginal bleeding
arm group label: Testosterone undecanoate
arm group type: Experimental
description: testosterone undecanoate 40 mg orally twice a week plus progynova 1mg oral daily
arm group label: placebo
arm group type: Placebo Comparator
description: placebo twice a week with progynova 1 mg oral daily
intervention type: Drug
intervention name: Testosterone undecanoate
description: testosterone undecanoate 40 mg orally twice a week
arm group label: Testosterone undecanoate
other name: Andriol
intervention type: Drug
intervention name: placebo
description: placebo orally twice a week with progynova 1 mg oral daily
arm group label: placebo
criteria: 
gender: Female
minimum age: 40 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Reuthairat Tungmunsakulchai, MD
role: Principal Investigator
affiliation: Menopause unit of Chulalongkorn hospital
facility: 
country: Thailand
citation: Floter A, Nathorst-Boos J, Carlstrom K, von Schoultz B. Addition of testosterone to estrogen replacement therapy in oophorectomized women: effects on sexuality and well-being. Climacteric. 2002 Dec;5(4):357-65.
PMID: 12626215
responsible party type: Sponsor
mesh term: Methyltestosterone
mesh term: Testosterone
mesh term: Testosterone undecanoate
mesh term: Testosterone enanthate
mesh term: Testosterone 17 beta-cypionate
submitted: May 19, 2014
submission canceled: Unknown
submitted: January 23, 2015
returned: February 6, 2015