<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/NCT02215434</url>
  </required_header>
  <id_info>
    <org_study_id>UNP/CNPq02</org_study_id>
    <nct_id>NCT02215434</nct_id>
  </id_info>
  <brief_title>Safety Study of Transdermal Testosterone for Low Libido in Pre and Postmenopausal Women</brief_title>
  <acronym>TESTOSTERONE</acronym>
  <official_title>Phase 2 Study of Transdermal Testosterone for Low Libido in Pre and Postmenopausal Women</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Potiguar</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Universidade Federal do Ceara</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Federal Institute of Science and Technology of Ceara</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Potiguar</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Female sexual dysfunction (FSD) is an established side effect of Selective serotonin reuptake&#xD;
      inhibitors (SSRIs) and serotonin noradrenalin reuptake inhibitors (SNRIs), causing symptoms&#xD;
      such as loss of libido, arousal difficulties, or delayed orgasm or anorgasmia.&#xD;
&#xD;
      Efficacy of testosterone therapy for the treatment of hypoactive sexual desire disorder&#xD;
      (HSDD) in women has been demonstrated in studies including naturally and surgically&#xD;
      menopausal women, either alone or in combination with estrogen, with or without progestin&#xD;
      therapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Recent studies have reported an increase in the number of satisfactory sexual events recorded&#xD;
      in a 4-week daily diary, as a primary outcome, and reduction in associated personal distress.&#xD;
&#xD;
      There is also evidence that testosterone therapy results in a similar improvement in sexual&#xD;
      function in premenopausal women with loss of libido.&#xD;
&#xD;
      Testosterone therapy has been associated with significantly improved well-being in studies in&#xD;
      which the participants had low well-being at enrollment.&#xD;
&#xD;
      Trials of testosterone for HSDD in women have excluded those with clinical depression, as&#xD;
      well as those taking antidepressants.&#xD;
&#xD;
      Whether testosterone will benefit women with HSDD who are taking an antidepressant is not&#xD;
      known.&#xD;
&#xD;
      The primary aim of this study was to examine the effects of transdermal testosterone therapy&#xD;
      with a nanoemulsion BIOLIPID B2 on sexual function in women at midlife, who were experiencing&#xD;
      treatment-emergent low libido. The primary study outcome was the change in the total score of&#xD;
      the Sabbatsberg Sexual Self-rating Scale (SSS).&#xD;
&#xD;
      In line with previous studies of women without depression, efficacy was measured by the&#xD;
      change in the frequency of SSEs over 4 weeks, as well as the domains of the SSS, general&#xD;
      well-being, depression, and mood status.&#xD;
&#xD;
      In this present study these factors will be analized in 12 weeks interval&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2009</start_date>
  <completion_date type="Actual">August 2014</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>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>satisfactory sexual events</measure>
    <time_frame>12 weeks</time_frame>
    <description>Recent studies have reported an increase in the number of satisfactory sexual events (SSEs) recorded in a 4-week daily diary, as a primary outcome, and reduction in associated personal distress.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Total testosterone and SHBG levels at screening and after 12 weeks of treatment.</measure>
    <time_frame>12 weeks</time_frame>
    <description>Total testosterone and SHBG levels were determined at screening and week 12.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Safety of transdermal Testosterone Biolipid B2 effects</measure>
    <time_frame>12 weeks</time_frame>
    <description>Safety is assessed by comparing the rates of adverse events in the two treatment groups. Androgenic side effects including the frequency of facial depilation per month, hirsutism by the Ferriman-Gallwey scale (range 0-4 for each of nine body regions), acne by the Palatsi scale and clitoromegaly by examination were assessed at screening and the final visit.&#xD;
We also monitor vital signs and concomitant medications.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Sex Behavior</condition>
  <arm_group>
    <arm_group_label>Biolipid B2 (blanked/placebo)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>The study is a single-center, single-blind, placebo-controlled, parallel group trial.&#xD;
It consists of a 4-week screening period plus a 12-week treatment phase. At the screening visit, all participants underwent a physical examination including vital signs and breast and pelvic examination.&#xD;
They were randomly assigned in a 1:1 ratio to receive a transdermal vehicle biolipid B2 (identical placebo) provided by Evidence Pharmaceuticals Inc, SP,BRAZIL.&#xD;
The testosterone and placebo emulsion were alcohol-free matrixes that were applied topically to the forearm daily for the period of 12 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Testosterone, Transdermal, Behavior</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Testosterone 0.5%, daily, 3 months</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Biolipid B2 (blanked/placebo)</intervention_name>
    <description>the intervention will be the comparison effects of both emulsions</description>
    <arm_group_label>Biolipid B2 (blanked/placebo)</arm_group_label>
    <arm_group_label>Testosterone, Transdermal, Behavior</arm_group_label>
    <other_name>Biolipid B2 0.5% testosterone, Evidence, Fortaleza, Brazil</other_name>
    <other_name>Biolipid B2 0.5% testosterone, Pharmacom, São Paulo, Brazil</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Testosterone, Transdermal, Behavior</intervention_name>
    <description>Transdermal 0.5% testosterone Biolipid/B2</description>
    <arm_group_label>Biolipid B2 (blanked/placebo)</arm_group_label>
    <arm_group_label>Testosterone, Transdermal, Behavior</arm_group_label>
    <other_name>Transdermal testosterone Biolipid/B2</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  a body mass index between 18 and 35 kg/m2&#xD;
&#xD;
          -  diminished libido complaints&#xD;
&#xD;
          -  no evidence of severe clinical depression&#xD;
&#xD;
          -  participants in good health based on history and physical examination.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  a past history of neurological disorder&#xD;
&#xD;
          -  recent psychiatric or systemic illness&#xD;
&#xD;
          -  use of psychoactive medications&#xD;
&#xD;
          -  alcohol excess consumption or any other drug abuse.&#xD;
&#xD;
          -  women who had under gone treatment for cardiovascular disease, genital bleeding, acne,&#xD;
             depression, dyspareunia or those who had received oral androgen therapy in the&#xD;
             previous 3 months were excluded&#xD;
&#xD;
          -  in addition women taking medications known to interfere with sex steroid metabolism&#xD;
             were also excluded.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>89 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>MARCO A BOTELHO, M.Sc., Ph.D</last_name>
    <role>Study Director</role>
    <affiliation>University Potiguar</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Dinalva B Queiroz, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Potiguar</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Potiguar</name>
      <address>
        <city>Natal</city>
        <state>RN</state>
        <zip>59060</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <link>
    <url>http://www.scielo.br/scielo.php?script=sci_arttext&amp;pid=S1807-59322014000200075&amp;lng=en&amp;nrm=iso&amp;tlng=en</url>
    <description>Article</description>
  </link>
  <results_reference>
    <citation>Botelho MA, Queiroz DB, Barros G, Guerreiro S, Fechine P, Umbelino S, Lyra A, Borges B, Freitas A, Queiroz DC, Ruela R, Almeida JG, Quintans L Jr. Nanostructured transdermal hormone replacement therapy for relieving menopausal symptoms: a confocal Raman spectroscopy study. Clinics (Sao Paulo). 2014 Feb;69(2):75-82. doi: 10.6061/clinics/2014(02)01.</citation>
    <PMID>24519196</PMID>
  </results_reference>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 12, 2014</study_first_submitted>
  <study_first_submitted_qc>August 12, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 13, 2014</study_first_posted>
  <last_update_submitted>August 12, 2014</last_update_submitted>
  <last_update_submitted_qc>August 12, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 13, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Libido; Sexual Dysfunction; 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>
  <!-- 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/NCT02215434
org study id: UNP/CNPq02
nct id: NCT02215434
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
Female sexual dysfunction (FSD) is an established side effect of Selective serotonin reuptake
      inhibitors (SSRIs) and serotonin noradrenalin reuptake inhibitors (SNRIs), causing symptoms
      such as loss of libido, arousal difficulties, or delayed orgasm or anorgasmia.

      Efficacy of testosterone therapy for the treatment of hypoactive sexual desire disorder
      (HSDD) in women has been demonstrated in studies including naturally and surgically
      menopausal women, either alone or in combination with estrogen, with or without progestin
      therapy.
Recent studies have reported an increase in the number of satisfactory sexual events recorded
      in a 4-week daily diary, as a primary outcome, and reduction in associated personal distress.

      There is also evidence that testosterone therapy results in a similar improvement in sexual
      function in premenopausal women with loss of libido.

      Testosterone therapy has been associated with significantly improved well-being in studies in
      which the participants had low well-being at enrollment.

      Trials of testosterone for HSDD in women have excluded those with clinical depression, as
      well as those taking antidepressants.

      Whether testosterone will benefit women with HSDD who are taking an antidepressant is not
      known.

      The primary aim of this study was to examine the effects of transdermal testosterone therapy
      with a nanoemulsion BIOLIPID B2 on sexual function in women at midlife, who were experiencing
      treatment-emergent low libido. The primary study outcome was the change in the total score of
      the Sabbatsberg Sexual Self-rating Scale (SSS).

      In line with previous studies of women without depression, efficacy was measured by the
      change in the frequency of SSEs over 4 weeks, as well as the domains of the SSS, general
      well-being, depression, and mood status.

      In this present study these factors will be analized in 12 weeks interval
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: satisfactory sexual events
time frame: 12 weeks
description: Recent studies have reported an increase in the number of satisfactory sexual events (SSEs) recorded in a 4-week daily diary, as a primary outcome, and reduction in associated personal distress.
measure: Total testosterone and SHBG levels at screening and after 12 weeks of treatment.
time frame: 12 weeks
description: Total testosterone and SHBG levels were determined at screening and week 12.
measure: Safety of transdermal Testosterone Biolipid B2 effects
time frame: 12 weeks
description: Safety is assessed by comparing the rates of adverse events in the two treatment groups. Androgenic side effects including the frequency of facial depilation per month, hirsutism by the Ferriman-Gallwey scale (range 0-4 for each of nine body regions), acne by the Palatsi scale and clitoromegaly by examination were assessed at screening and the final visit.
We also monitor vital signs and concomitant medications.
arm group label: Biolipid B2 (blanked/placebo)
arm group type: Placebo Comparator
description: The study is a single-center, single-blind, placebo-controlled, parallel group trial.
It consists of a 4-week screening period plus a 12-week treatment phase. At the screening visit, all participants underwent a physical examination including vital signs and breast and pelvic examination.
They were randomly assigned in a 1:1 ratio to receive a transdermal vehicle biolipid B2 (identical placebo) provided by Evidence Pharmaceuticals Inc, SP,BRAZIL.
The testosterone and placebo emulsion were alcohol-free matrixes that were applied topically to the forearm daily for the period of 12 weeks.
arm group label: Testosterone, Transdermal, Behavior
arm group type: Active Comparator
description: Testosterone 0.5%, daily, 3 months
intervention type: Drug
intervention name: Biolipid B2 (blanked/placebo)
description: the intervention will be the comparison effects of both emulsions
arm group label: Biolipid B2 (blanked/placebo)
arm group label: Testosterone, Transdermal, Behavior
other name: Biolipid B2 0.5% testosterone, Evidence, Fortaleza, Brazil
other name: Biolipid B2 0.5% testosterone, Pharmacom, São Paulo, Brazil
intervention type: Drug
intervention name: Testosterone, Transdermal, Behavior
description: Transdermal 0.5% testosterone Biolipid/B2
arm group label: Biolipid B2 (blanked/placebo)
arm group label: Testosterone, Transdermal, Behavior
other name: Transdermal testosterone Biolipid/B2
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 89 Years
healthy volunteers: Accepts Healthy Volunteers
last name: MARCO A BOTELHO, M.Sc., Ph.D
role: Study Director
affiliation: University Potiguar
last name: Dinalva B Queiroz, PhD
role: Principal Investigator
affiliation: University Potiguar
facility: 
country: Brazil
url: http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1807-59322014000200075&lng=en&nrm=iso&tlng=en
description: Article
citation: Botelho MA, Queiroz DB, Barros G, Guerreiro S, Fechine P, Umbelino S, Lyra A, Borges B, Freitas A, Queiroz DC, Ruela R, Almeida JG, Quintans L Jr. Nanostructured transdermal hormone replacement therapy for relieving menopausal symptoms: a confocal Raman spectroscopy study. Clinics (Sao Paulo). 2014 Feb;69(2):75-82. doi: 10.6061/clinics/2014(02)01.
PMID: 24519196
responsible party type: Sponsor
mesh term: Methyltestosterone
mesh term: Testosterone
mesh term: Testosterone undecanoate
mesh term: Testosterone enanthate
mesh term: Testosterone 17 beta-cypionate