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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
80
Use of tadalafil in the treatment of FSIAD
Use of placebo in control group
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.
Time frame: 14 weeks
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.
Time frame: 14 weeks
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.
Time frame: 14 weeks
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.
Time frame: 14 weeks
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.
Time frame: 14 weeks
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.
Time frame: 14 weeks
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.
Time frame: 14 weeks
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