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

Phase 3

• Conditions: Sexual Dysfunctions, Psychological
• Interventions: Drug: Tadalafil 1,5 mg oral tablets; Drug: Placebo oral tablets

• Registration Number: NCT04433559
• Lead Sponsor: Lidia Larrañaga

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

Study Timeline

• Study First Submitted: 2020-05-06
• Status Verified: 2020-06
• Study First Submitted QC: 2020-06-12
• Last Update Submitted: 2020-06-12
• Study First Posted: 2020-06-16
• Last Update Posted: 2020-06-16
• Study Start: 2020-08
• Primary Completion: 2021-08
• Study Completion: 2021-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 80

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group Active Tadalafile	Tadalafil 1,5 mg oral tablets	One oral tablet of 1.5 mg IPDE daily for 14 weeks of treatment.
Group Placebo	Placebo oral tablets	One oral tablet of placebo daily for 14 weeks of treatment.

Primary Outcome Measures

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

Secondary Outcome Measures

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