<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/NCT04433559</url>
  </required_header>
  <id_info>
    <org_study_id>LITA-004</org_study_id>
    <nct_id>NCT04433559</nct_id>
  </id_info>
  <brief_title>Study of Pharmacological Treatment in Women With Female Sexual Interest/Arousal Disorder (FSIAD).</brief_title>
  <acronym>FSIAD</acronym>
  <official_title>Randomized, Double-blind, Two-arms Study With Parallel Groups to Determine the Effect of a Phosphodiesterase Inhibitor for 14 Weeks of Treatment Versus Placebo in Women With FSIAD.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lidia Larrañaga</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Laboratorios LITAPHAR, S.L.</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This clinical trial is a prospective, randomized, double-blind Phase III study with two arms&#xD;
      to determine the efficacy and safety of the use of an IPDE in women with FSIAD.&#xD;
&#xD;
      Patients who meet all inclusion criteria and do not meet any of the exclusion criteria will&#xD;
      enter the study and receive active product or placebo for 14 weeks.&#xD;
&#xD;
      Patients will be assigned to each treatment group in a randomized and parallel manner. In&#xD;
      addition, all volunteers participating in the study will receive medical advice during the&#xD;
      study.&#xD;
&#xD;
      The study will have a duration of minimum of 18 weeks and will consist of 3 periods.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This clinical trial is a prospective, randomized, double-blind Phase III study with two arms&#xD;
      to determine the efficacy and safety of the use of an IPDE in women with FSIAD.&#xD;
&#xD;
      Patients who meet all inclusion criteria and do not meet any of the exclusion criteria will&#xD;
      enter the study and receive active product or placebo for 14 weeks.&#xD;
&#xD;
      Patients will be assigned to each treatment group in a randomized and parallel manner. In&#xD;
      addition, all volunteers participating in the study will receive medical advice during the&#xD;
      study.&#xD;
&#xD;
      The study will have a duration of minimum of 18 weeks and will consist of 3 periods&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">August 2020</start_date>
  <completion_date type="Anticipated">August 2021</completion_date>
  <primary_completion_date type="Anticipated">August 2021</primary_completion_date>
  <phase>Phase 3</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>Effect of IPDE (Tadalafile) according to FSFI (Female Sexual Function Index)</measure>
    <time_frame>14 weeks</time_frame>
    <description>To determine the effect of IPDE at a dose of 1.5 mg versus placebo in women with disorders of interest and sexual arousal using the FSFI (Female Sexual Function Index).&#xD;
FSFI contains 19 questions, with each questions with a value minimum of 0 and maximum of 6 points, beeing 0 the worst scenario y 6 the best scenario.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Comparative IPDE Vs placebo according to FSFI</measure>
    <time_frame>14 weeks</time_frame>
    <description>To compare the effect of IPDE with respect to placebo in women with disorders of interest and sexual arousal using the FSFI (Female Sexual Function Index).&#xD;
FSFI contains 19 questions, with each questions with a value minimum of 0 and maximum of 6 points, beeing 0 the worst scenario y 6 the best scenario.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparaive of IPDE Vs placebo according NSSS-Short (New Sexual Satisfaction Scale)</measure>
    <time_frame>14 weeks</time_frame>
    <description>To compare the effect of IPDE with respect to placebo in women with disorders of interest and sexual arousal using the questionnaire &quot;The New Sexual Satisfaction Scale&quot; (NSSS-Short).&#xD;
NSSS-Short (New Sexual Satisfaction Scale) contains 7 questions, with each questions with a value minimum of 0 and maximum of 100 points, beeing 0 the worst scenario y 100 the best scenario.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparative IPDE Vs placebo according to the TSQM (Treatment Satisfaction questionnaire for Medication)</measure>
    <time_frame>14 weeks</time_frame>
    <description>To compare the effect of IPDE with respect to placebo in women with disorders of interest and sexual arousal using the &quot;Treatment Satisfaction questionnaire for Medication&quot; (TSQM) version 1.4.&#xD;
TSQM (Treatment Satisfaction questionnaire for Medication) contains 14 questions with each questions with a value minimum of 0 and maximum of 80 points, beeing 0 the worst scenario y 80 the best scenario.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparative of IPDE Vs placebo according to number of sexual events</measure>
    <time_frame>14 weeks</time_frame>
    <description>To compare the effect of IPDE with respect to placebo in women with sexual interest and arousal disorder by measuring the number of sexual events recorded in the weekly diary.&#xD;
The diary will be fullfilled by the women according to the number of sexual events.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparative of IPDE Vs placebo according to the sexual satisfaction</measure>
    <time_frame>14 weeks</time_frame>
    <description>To compare the effect of IPDE with respect to placebo in women with sexual interest and arousal disorder by measuring the sexual satisfaction of sexual intercourse.&#xD;
The scale will contain 3 questions, with a visual analog scale. This visual analog scale will contain a scale with different visual easy identificable progesion faces, from very sad face to very happy face, beeging the first sad face, the no satisfaction point, and the last very happy face the very satisfactory sexual event point.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparative of IPDE Vs placebo according to ease of arousal</measure>
    <time_frame>14 weeks</time_frame>
    <description>To compare the effect of IPDE with respect to placebo in women with disorder of interest and sexual arousal by measuring the ease of arousal during sexual intercourse determined using an analog visual scale.&#xD;
The scale will contain 3 questions, with a visual analog scale. This visual analog scale will contain a scale with different visual easy identificable progesion faces, from very sad face to very happy face, beeging the first sad face, the no satisfaction point, and the last very happy face the very satisfactory sexual event point.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Sexual Dysfunctions, Psychological</condition>
  <arm_group>
    <arm_group_label>Group Active Tadalafile</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>One oral tablet of 1.5 mg IPDE daily for 14 weeks of treatment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>One oral tablet of placebo daily for 14 weeks of treatment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tadalafil 1,5 mg oral tablets</intervention_name>
    <description>Use of tadalafil in the treatment of FSIAD</description>
    <arm_group_label>Group Active Tadalafile</arm_group_label>
    <other_name>Tadalafil</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo oral tablets</intervention_name>
    <description>Use of placebo in control group</description>
    <arm_group_label>Group Placebo</arm_group_label>
    <other_name>Placebo</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Women between 18 and 65 years old. Women of childbearing age (premenopausal, not&#xD;
             surgically sterilized at least 3 months before the Selection Visit) must be used&#xD;
             during the study a highly effective contraceptive method such as:&#xD;
&#xD;
               -  contraceptive methods or partner vasectomy, and confirm who are not pregnant by&#xD;
                  pregnancy test negative in the Selection Consultation.&#xD;
&#xD;
                  2. Signature of the informed consent obtained in writing,including a data&#xD;
                  protection declaration before the participation in the study.&#xD;
&#xD;
                  3. Women with disorders of interest and sexual arousal diagnosed using a&#xD;
                  semi-structured questionnaire of 5 questions based on DSM-V criteria.&#xD;
&#xD;
        Exclusion Criteria :&#xD;
&#xD;
          1. The following groups of patients with cardiovascular risk:&#xD;
&#xD;
               -  Patients who had suffered myocardial infarction in the 90s previous days,&#xD;
&#xD;
               -  Patients with unstable angina or angina produced during sexual activity,&#xD;
&#xD;
               -  Patients with heart failure corresponding to class II or higher than the New York&#xD;
                  Heart Association classification (NYHA) in the previous 6 months,&#xD;
&#xD;
               -  Patients with uncontrolled arrhythmias,&#xD;
&#xD;
               -  Patients who had suffered a stroke in the previous 6 months.&#xD;
&#xD;
          2. Patients with disorders of female sexual arousal of origin neurogenic.&#xD;
&#xD;
          3. Patients with female sexual dysfunction associated with disorders psychiatric.&#xD;
&#xD;
          4. Patients with a partner who suffers from sexual dysfunction.&#xD;
&#xD;
          5. Patients with dysphoric excitation disorder and / or with sensation unpleasant genital&#xD;
             thickening.&#xD;
&#xD;
          6. Patients with a history of severe thromboembolic disease, hepatic, renal, or&#xD;
             neoplastic.&#xD;
&#xD;
          7. Uncontrolled diabetic patients (HbA1c&gt; 8% in the last control).&#xD;
&#xD;
          8. Patients with depression and / or taking antidepressants.&#xD;
&#xD;
          9. Lactation&#xD;
&#xD;
         10. Hypersensitivity to tadalafil and / or drugs and products related (including&#xD;
             excipients of the formulation).&#xD;
&#xD;
         11. Patients undergoing treatment with any form of organic nitrate.&#xD;
&#xD;
         12. Patients on treatment with potent CYP3A4 inhibitors (ritonavir, ketoconazole,&#xD;
             itraconazole, clarithromycin, erythromycin, and saquinavir) and strong CYP3A4 inducers&#xD;
             (carbamazepine, phenytoin, phenobarbital, St. John's wort, rifampin).&#xD;
&#xD;
         13. Patients who have loss of vision in one eye a consequence of anterior ischemic optic&#xD;
             neuropathy not arteritic.&#xD;
&#xD;
         14. Patients with any pelvic surgery in the previous 6 months.&#xD;
&#xD;
         15. Known history of drug and / or alcohol abuse in the 6 months prior to the selection&#xD;
             consultation.&#xD;
&#xD;
         16. Participation in another study in the 3 months prior to the consultation of selection.&#xD;
&#xD;
         17. Any illness that, in the investigator's judgment, can interfere with compliance with&#xD;
             study procedures or study evaluations.&#xD;
&#xD;
         18. Patient with any medical or surgical condition that may interfere with absorption,&#xD;
             distribution, metabolism or excretion of the study drug according to the criteria of&#xD;
             the researcher.&#xD;
&#xD;
         19. Patients in judicial or police custody.&#xD;
&#xD;
         20. Patients with difficulties in understanding the language in which they gives the&#xD;
             information to the subject.&#xD;
&#xD;
         21. Patients who do not agree to the transmission of their anonymous data regarding the&#xD;
             documentation and notification functions.&#xD;
&#xD;
         22. Study center, sponsor or CRO staff, their own researcher or relatives of the same.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>May 6, 2020</study_first_submitted>
  <study_first_submitted_qc>June 12, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>June 12, 2020</last_update_submitted>
  <last_update_submitted_qc>June 12, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Laboratorios LITAPHAR, S.L.</investigator_affiliation>
    <investigator_full_name>Lidia Larrañaga</investigator_full_name>
    <investigator_title>Clinical Trial Coordinator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sexual Dysfunctions, Psychological</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tadalafil</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/NCT04433559
org study id: LITA-004
nct id: NCT04433559
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
This clinical trial is a prospective, randomized, double-blind Phase III study with two arms
      to determine the efficacy and safety of the use of an IPDE in women with FSIAD.

      Patients who meet all inclusion criteria and do not meet any of the exclusion criteria will
      enter the study and receive active product or placebo for 14 weeks.

      Patients will be assigned to each treatment group in a randomized and parallel manner. In
      addition, all volunteers participating in the study will receive medical advice during the
      study.

      The study will have a duration of minimum of 18 weeks and will consist of 3 periods.
This clinical trial is a prospective, randomized, double-blind Phase III study with two arms
      to determine the efficacy and safety of the use of an IPDE in women with FSIAD.

      Patients who meet all inclusion criteria and do not meet any of the exclusion criteria will
      enter the study and receive active product or placebo for 14 weeks.

      Patients will be assigned to each treatment group in a randomized and parallel manner. In
      addition, all volunteers participating in the study will receive medical advice during the
      study.

      The study will have a duration of minimum of 18 weeks and will consist of 3 periods
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Effect of IPDE (Tadalafile) according to FSFI (Female Sexual Function Index)
time frame: 14 weeks
description: To determine the effect of IPDE at a dose of 1.5 mg versus placebo in women with disorders of interest and sexual arousal using the FSFI (Female Sexual Function Index).
FSFI contains 19 questions, with each questions with a value minimum of 0 and maximum of 6 points, beeing 0 the worst scenario y 6 the best scenario.
measure: Comparative IPDE Vs placebo according to FSFI
time frame: 14 weeks
description: To compare the effect of IPDE with respect to placebo in women with disorders of interest and sexual arousal using the FSFI (Female Sexual Function Index).
FSFI contains 19 questions, with each questions with a value minimum of 0 and maximum of 6 points, beeing 0 the worst scenario y 6 the best scenario.
measure: Comparaive of IPDE Vs placebo according NSSS-Short (New Sexual Satisfaction Scale)
time frame: 14 weeks
description: To compare the effect of IPDE with respect to placebo in women with disorders of interest and sexual arousal using the questionnaire "The New Sexual Satisfaction Scale" (NSSS-Short).
NSSS-Short (New Sexual Satisfaction Scale) contains 7 questions, with each questions with a value minimum of 0 and maximum of 100 points, beeing 0 the worst scenario y 100 the best scenario.
measure: Comparative IPDE Vs placebo according to the TSQM (Treatment Satisfaction questionnaire for Medication)
time frame: 14 weeks
description: To compare the effect of IPDE with respect to placebo in women with disorders of interest and sexual arousal using the "Treatment Satisfaction questionnaire for Medication" (TSQM) version 1.4.
TSQM (Treatment Satisfaction questionnaire for Medication) contains 14 questions with each questions with a value minimum of 0 and maximum of 80 points, beeing 0 the worst scenario y 80 the best scenario.
measure: Comparative of IPDE Vs placebo according to number of sexual events
time frame: 14 weeks
description: To compare the effect of IPDE with respect to placebo in women with sexual interest and arousal disorder by measuring the number of sexual events recorded in the weekly diary.
The diary will be fullfilled by the women according to the number of sexual events.
measure: Comparative of IPDE Vs placebo according to the sexual satisfaction
time frame: 14 weeks
description: To compare the effect of IPDE with respect to placebo in women with sexual interest and arousal disorder by measuring the sexual satisfaction of sexual intercourse.
The scale will contain 3 questions, with a visual analog scale. This visual analog scale will contain a scale with different visual easy identificable progesion faces, from very sad face to very happy face, beeging the first sad face, the no satisfaction point, and the last very happy face the very satisfactory sexual event point.
measure: Comparative of IPDE Vs placebo according to ease of arousal
time frame: 14 weeks
description: To compare the effect of IPDE with respect to placebo in women with disorder of interest and sexual arousal by measuring the ease of arousal during sexual intercourse determined using an analog visual scale.
The scale will contain 3 questions, with a visual analog scale. This visual analog scale will contain a scale with different visual easy identificable progesion faces, from very sad face to very happy face, beeging the first sad face, the no satisfaction point, and the last very happy face the very satisfactory sexual event point.
arm group label: Group Active Tadalafile
arm group type: Active Comparator
description: One oral tablet of 1.5 mg IPDE daily for 14 weeks of treatment.
arm group label: Group Placebo
arm group type: Placebo Comparator
description: One oral tablet of placebo daily for 14 weeks of treatment.
intervention type: Drug
intervention name: Tadalafil 1,5 mg oral tablets
description: Use of tadalafil in the treatment of FSIAD
arm group label: Group Active Tadalafile
other name: Tadalafil
intervention type: Drug
intervention name: Placebo oral tablets
description: Use of placebo in control group
arm group label: Group Placebo
other name: Placebo
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
responsible party type: Sponsor-Investigator
investigator affiliation: Laboratorios LITAPHAR, S.L.
investigator full name: Lidia Larrañaga
investigator title: Clinical Trial Coordinator
mesh term: Sexual Dysfunctions, Psychological
mesh term: Tadalafil
sharing ipd: No