Clinical trial NCT04433559: Study of Pharmacological Treatment in Women With Female Sexual Interest/Arousal Disorder (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
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Sexual Dysfunctions, Psychological
Lead sponsor: Laboratorios LITAPHAR, S.L.
Sponsor class: INDUSTRY
First posted: 2020-06-16
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

Primary outcomes:
measure: Effect of IPDE (Tadalafile) according to FSFI (Female Sexual Function Index)
timeFrame: 14 weeks
Secondary outcomes:
measure: Comparative IPDE Vs placebo according to FSFI
timeFrame: 14 weeks
measure: Comparaive of IPDE Vs placebo according NSSS-Short (New Sexual Satisfaction Scale)
timeFrame: 14 weeks
measure: Comparative IPDE Vs placebo according to the TSQM (Treatment Satisfaction questionnaire for Medication)
timeFrame: 14 weeks
measure: Comparative of IPDE Vs placebo according to number of sexual events
timeFrame: 14 weeks
measure: Comparative of IPDE Vs placebo according to the sexual satisfaction
timeFrame: 14 weeks
measure: Comparative of IPDE Vs placebo according to ease of arousal
timeFrame: 14 weeks
Other outcomes:
Locations:
Study officials:
References: