drugset / Trial / NCT04433559

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

NCT04433559

Phase 3 Unknown 80 enrolled Lidia Larrañaga
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2020-08
Primary completion
2021-08
Completion
2021-08

Drugs

EvaluationDrugModalityDoseRoute
Comparator Tadalafil Small molecule 1.5 mg Oral

Indications