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

NCT04433559 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2020-06-16

No results posted yet for this study

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

Interventions

DRUG

Tadalafil 1,5 mg oral tablets

Use of tadalafil in the treatment of FSIAD

DRUG

Placebo oral tablets

Use of placebo in control group

Sponsors & Collaborators

  • Lidia Larrañaga

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-31
Primary Completion
2021-08-31
Completion
2021-08-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04433559 on ClinicalTrials.gov