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

Lidia Larrañaga

Status and phase: Unknown; Phase 3

Conditions: Sexual Dysfunctions, Psychological

Treatments: Drug: Placebo oral tablets; Drug: Tadalafil 1,5 mg oral tablets

Study type: Interventional

Funder types: Industry

Identifiers

NCT04433559

LITA-004

Details and patient eligibility

About

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.

Full 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

Enrollment: 80 estimated patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups, including a placebo group

Group Active Tadalafile

Active Comparator group

Description:

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

Treatment:

Drug: Tadalafil 1,5 mg oral tablets

Group Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo oral tablets