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

June 12, 2020 updated by: Lidia Larrañaga

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.

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.

Study Overview

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

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group Active Tadalafile
One oral tablet of 1.5 mg IPDE daily for 14 weeks of treatment.
Use of tadalafil in the treatment of FSIAD
Other Names:
  • Tadalafil
Placebo Comparator: Group Placebo
One oral tablet of placebo daily for 14 weeks of treatment.
Use of placebo in control group
Other Names:
  • Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of IPDE (Tadalafile) according to FSFI (Female Sexual Function Index)
Time Frame: 14 weeks

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.

14 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparative IPDE Vs placebo according to FSFI
Time Frame: 14 weeks

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.

14 weeks
Comparaive of IPDE Vs placebo according NSSS-Short (New Sexual Satisfaction Scale)
Time Frame: 14 weeks

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.

14 weeks
Comparative IPDE Vs placebo according to the TSQM (Treatment Satisfaction questionnaire for Medication)
Time Frame: 14 weeks

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.

14 weeks
Comparative of IPDE Vs placebo according to number of sexual events
Time Frame: 14 weeks

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.

14 weeks
Comparative of IPDE Vs placebo according to the sexual satisfaction
Time Frame: 14 weeks

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.

14 weeks
Comparative of IPDE Vs placebo according to ease of arousal
Time Frame: 14 weeks

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.

14 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 1, 2020

Primary Completion (Anticipated)

August 1, 2021

Study Completion (Anticipated)

August 1, 2021

Study Registration Dates

First Submitted

May 6, 2020

First Submitted That Met QC Criteria

June 12, 2020

First Posted (Actual)

June 16, 2020

Study Record Updates

Last Update Posted (Actual)

June 16, 2020

Last Update Submitted That Met QC Criteria

June 12, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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