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Study of Pharmacological Treatment in Women With Female Sexual Interest/Arousal Disorder (FSIAD). (FSIAD)

Primary Purpose

Sexual Dysfunctions, Psychological

Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Tadalafil 1,5 mg oral tablets
Placebo oral tablets
Sponsored by
Lidia Larrañaga
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sexual Dysfunctions, Psychological

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Women between 18 and 65 years old. Women of childbearing age (premenopausal, not surgically sterilized at least 3 months before the Selection Visit) must be used during the study a highly effective contraceptive method such as:

    • contraceptive methods or partner vasectomy, and confirm who are not pregnant by pregnancy test negative in the Selection Consultation.

      2. Signature of the informed consent obtained in writing,including a data protection declaration before the participation in the study.

      3. Women with disorders of interest and sexual arousal diagnosed using a semi-structured questionnaire of 5 questions based on DSM-V criteria.

Exclusion Criteria :

  1. The following groups of patients with cardiovascular risk:

    • Patients who had suffered myocardial infarction in the 90s previous days,
    • Patients with unstable angina or angina produced during sexual activity,
    • Patients with heart failure corresponding to class II or higher than the New York Heart Association classification (NYHA) in the previous 6 months,
    • Patients with uncontrolled arrhythmias,
    • Patients who had suffered a stroke in the previous 6 months.
  2. Patients with disorders of female sexual arousal of origin neurogenic.
  3. Patients with female sexual dysfunction associated with disorders psychiatric.
  4. Patients with a partner who suffers from sexual dysfunction.
  5. Patients with dysphoric excitation disorder and / or with sensation unpleasant genital thickening.
  6. Patients with a history of severe thromboembolic disease, hepatic, renal, or neoplastic.
  7. Uncontrolled diabetic patients (HbA1c> 8% in the last control).
  8. Patients with depression and / or taking antidepressants.
  9. Lactation
  10. Hypersensitivity to tadalafil and / or drugs and products related (including excipients of the formulation).
  11. Patients undergoing treatment with any form of organic nitrate.
  12. Patients on treatment with potent CYP3A4 inhibitors (ritonavir, ketoconazole, itraconazole, clarithromycin, erythromycin, and saquinavir) and strong CYP3A4 inducers (carbamazepine, phenytoin, phenobarbital, St. John's wort, rifampin).
  13. Patients who have loss of vision in one eye a consequence of anterior ischemic optic neuropathy not arteritic.
  14. Patients with any pelvic surgery in the previous 6 months.
  15. Known history of drug and / or alcohol abuse in the 6 months prior to the selection consultation.
  16. Participation in another study in the 3 months prior to the consultation of selection.
  17. Any illness that, in the investigator's judgment, can interfere with compliance with study procedures or study evaluations.
  18. Patient with any medical or surgical condition that may interfere with absorption, distribution, metabolism or excretion of the study drug according to the criteria of the researcher.
  19. Patients in judicial or police custody.
  20. Patients with difficulties in understanding the language in which they gives the information to the subject.
  21. Patients who do not agree to the transmission of their anonymous data regarding the documentation and notification functions.
  22. Study center, sponsor or CRO staff, their own researcher or relatives of the same.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Group Active Tadalafile

    Group Placebo

    Arm Description

    One oral tablet of 1.5 mg IPDE daily for 14 weeks of treatment.

    One oral tablet of placebo daily for 14 weeks of treatment.

    Outcomes

    Primary Outcome Measures

    Effect of IPDE (Tadalafile) according to FSFI (Female Sexual Function Index)
    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.

    Secondary Outcome Measures

    Comparative IPDE Vs placebo according to FSFI
    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.
    Comparaive of IPDE Vs placebo according NSSS-Short (New Sexual Satisfaction Scale)
    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.
    Comparative IPDE Vs placebo according to the TSQM (Treatment Satisfaction questionnaire for Medication)
    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.
    Comparative of IPDE Vs placebo according to number of sexual events
    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.
    Comparative of IPDE Vs placebo according to the sexual satisfaction
    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.
    Comparative of IPDE Vs placebo according to ease of arousal
    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.

    Full Information

    First Posted
    May 6, 2020
    Last Updated
    June 12, 2020
    Sponsor
    Lidia Larrañaga
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04433559
    Brief Title
    Study of Pharmacological Treatment in Women With Female Sexual Interest/Arousal Disorder (FSIAD).
    Acronym
    FSIAD
    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.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    August 2020 (Anticipated)
    Primary Completion Date
    August 2021 (Anticipated)
    Study Completion Date
    August 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Lidia Larrañaga

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Sexual Dysfunctions, Psychological

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    80 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Group Active Tadalafile
    Arm Type
    Active Comparator
    Arm Description
    One oral tablet of 1.5 mg IPDE daily for 14 weeks of treatment.
    Arm Title
    Group Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    One oral tablet of placebo daily for 14 weeks of treatment.
    Intervention Type
    Drug
    Intervention Name(s)
    Tadalafil 1,5 mg oral tablets
    Other Intervention Name(s)
    Tadalafil
    Intervention Description
    Use of tadalafil in the treatment of FSIAD
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo oral tablets
    Other Intervention Name(s)
    Placebo
    Intervention Description
    Use of placebo in control group
    Primary Outcome Measure Information:
    Title
    Effect of IPDE (Tadalafile) according to FSFI (Female Sexual Function Index)
    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.
    Time Frame
    14 weeks
    Secondary Outcome Measure Information:
    Title
    Comparative IPDE Vs placebo according to FSFI
    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.
    Time Frame
    14 weeks
    Title
    Comparaive of IPDE Vs placebo according NSSS-Short (New Sexual Satisfaction Scale)
    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.
    Time Frame
    14 weeks
    Title
    Comparative IPDE Vs placebo according to the TSQM (Treatment Satisfaction questionnaire for Medication)
    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.
    Time Frame
    14 weeks
    Title
    Comparative of IPDE Vs placebo according to number of sexual events
    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.
    Time Frame
    14 weeks
    Title
    Comparative of IPDE Vs placebo according to the sexual satisfaction
    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.
    Time Frame
    14 weeks
    Title
    Comparative of IPDE Vs placebo according to ease of arousal
    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.
    Time Frame
    14 weeks

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Women between 18 and 65 years old. Women of childbearing age (premenopausal, not surgically sterilized at least 3 months before the Selection Visit) must be used during the study a highly effective contraceptive method such as: contraceptive methods or partner vasectomy, and confirm who are not pregnant by pregnancy test negative in the Selection Consultation. 2. Signature of the informed consent obtained in writing,including a data protection declaration before the participation in the study. 3. Women with disorders of interest and sexual arousal diagnosed using a semi-structured questionnaire of 5 questions based on DSM-V criteria. Exclusion Criteria : The following groups of patients with cardiovascular risk: Patients who had suffered myocardial infarction in the 90s previous days, Patients with unstable angina or angina produced during sexual activity, Patients with heart failure corresponding to class II or higher than the New York Heart Association classification (NYHA) in the previous 6 months, Patients with uncontrolled arrhythmias, Patients who had suffered a stroke in the previous 6 months. Patients with disorders of female sexual arousal of origin neurogenic. Patients with female sexual dysfunction associated with disorders psychiatric. Patients with a partner who suffers from sexual dysfunction. Patients with dysphoric excitation disorder and / or with sensation unpleasant genital thickening. Patients with a history of severe thromboembolic disease, hepatic, renal, or neoplastic. Uncontrolled diabetic patients (HbA1c> 8% in the last control). Patients with depression and / or taking antidepressants. Lactation Hypersensitivity to tadalafil and / or drugs and products related (including excipients of the formulation). Patients undergoing treatment with any form of organic nitrate. Patients on treatment with potent CYP3A4 inhibitors (ritonavir, ketoconazole, itraconazole, clarithromycin, erythromycin, and saquinavir) and strong CYP3A4 inducers (carbamazepine, phenytoin, phenobarbital, St. John's wort, rifampin). Patients who have loss of vision in one eye a consequence of anterior ischemic optic neuropathy not arteritic. Patients with any pelvic surgery in the previous 6 months. Known history of drug and / or alcohol abuse in the 6 months prior to the selection consultation. Participation in another study in the 3 months prior to the consultation of selection. Any illness that, in the investigator's judgment, can interfere with compliance with study procedures or study evaluations. Patient with any medical or surgical condition that may interfere with absorption, distribution, metabolism or excretion of the study drug according to the criteria of the researcher. Patients in judicial or police custody. Patients with difficulties in understanding the language in which they gives the information to the subject. Patients who do not agree to the transmission of their anonymous data regarding the documentation and notification functions. Study center, sponsor or CRO staff, their own researcher or relatives of the same.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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