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

NCT04433559 | Unknown Phase 3

• 1 other identifier: LITA-004
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Sexual Dysfunctions, Psychological

Outcome Measures

Primary Outcomes (1)

• 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.

  14 weeks

Secondary Outcomes (6)

• Comparative IPDE Vs placebo according to FSFI

  14 weeks

• Comparaive of IPDE Vs placebo according NSSS-Short (New Sexual Satisfaction Scale)

  14 weeks

• Comparative IPDE Vs placebo according to the TSQM (Treatment Satisfaction questionnaire for Medication)

  14 weeks

• Comparative of IPDE Vs placebo according to number of sexual events

  14 weeks

• Comparative of IPDE Vs placebo according to the sexual satisfaction

  14 weeks

Study Arms (2)

Group Active Tadalafile

ACTIVE COMPARATOR

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

Drug: Tadalafil 1,5 mg oral tablets

Group Placebo

PLACEBO COMPARATOR

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

Drug: Placebo oral tablets

Interventions

Tadalafil 1,5 mg oral tablets DRUG

Use of tadalafil in the treatment of FSIAD

Also known as: Tadalafil

Group Active Tadalafile

Placebo oral tablets DRUG

Use of placebo in control group

Also known as: Placebo

Group Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• \. Signature of the informed consent obtained in writing,including a data protection declaration before the participation in the study.
• \. Women with disorders of interest and sexual arousal diagnosed using a semi-structured questionnaire of 5 questions based on DSM-V criteria.

You may not qualify if:

• 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.
• Patients with disorders of female sexual arousal of origin neurogenic.
• Patients with female sexual dysfunction associated with disorders psychiatric.
• Patients with a partner who suffers from sexual dysfunction.
• Patients with dysphoric excitation disorder and / or with sensation unpleasant genital thickening.
• Patients with a history of severe thromboembolic disease, hepatic, renal, or neoplastic.
• Uncontrolled diabetic patients (HbA1c\> 8% in the last control).
• Patients with depression and / or taking antidepressants.
• Lactation
• Hypersensitivity to tadalafil and / or drugs and products related (including excipients of the formulation).

Sponsors & Collaborators

• Lidia Larrañaga: lead

MeSH Terms

Conditions

Sexual Dysfunctions, Psychological

Interventions

Tadalafil

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Carbolines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indole Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Trial Coordinator

Study Record Dates

• First Submitted: May 6, 2020
• First Posted: June 16, 2020
• Study Start: August 1, 2020
• Primary Completion: August 1, 2021
• Study Completion: August 1, 2021
• Last Updated: June 16, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share